Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) Sort descending | Location(s) | Year Awarded |
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1R43NS132623-01
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Optogenetic Pain Modulator for Non-Opioid Chronic Pain Management | Cross-Cutting Research | Small Business Programs | NINDS | OPSIN BIOTHERAPEUTICS, INC. | NARCISSE, DARRYL | Bedford, TX | 2023 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Optogenetics is a method of controlling nerve or brain activity using light-sensitive cell receptors (opsins). Optogenetics has been used in brain research for decades, allowing researchers to understand the brain and its associated disorders by selectively turning on and off specific nerve cells. This project will develop and refine use of an opsin and a light-stimulation device to control nerve cells contributing to the sensation of pain. |
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1R44DA056251-01
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Booth™ by Opio™: Developing Technology to Expand the Reach of Opioid Treatment Programs into Rural and Underserved Areas | Cross-Cutting Research | Small Business Programs | NIDA | OPIO CONNECT, INC. | NORBECK, AMBER | Whitefish, MT | 2022 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: People with opioid use disorder living in rural and underserved areas often have limited access to treatment. This project will develop a robotic treatment booth that allows opioid treatment centers to dispense opioid use disorder medications, while providing medical observation via real-time telehealth services. This new technology will provide a contactless patient–provider experience and leverage the expertise to expand treatment access to additional rural and underserved areas. |
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1R43NS115294-01
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Developing EXP-1801 as an imaging agent to quantify pain and analgesia | Cross-Cutting Research | Small Business Programs | NINDS | EXPESICOR, INC. | NORWOOD, BRAXTON | Kalispell, MT | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: The use of a pain imaging technology would allow for objective efficacy data (both pre-clinically and in clinical trials), and reduce costs by enabling smaller sample sizes due to more homogeneous populations; i.e. with a particular “pain signal,” and more accurate measurement of analgesic effects. This research team recently invented a novel positron emission tomography (PET) imaging agent as a tool to address these issues in pain care and therapy development. Although the ability of PET to detect pathological changes for (early) disease detection is widely used in cancer and neurological diseases, it has not yet been used for pain indications. The goals of this project are: 1) to change the evaluation of (experimental) pain therapies, and 2) the standard of care in pain assessment through molecular imaging. The proposed study is designed to determine the feasibility of our imaging agent to objectively measure pain in rodents. This will set the stage for a Phase II study that further develops this agent into a tool for quantifying pain/analgesia. |
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1R41NS118992-01
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Development of selective calpain-1 inhibitors for chronic pain | Cross-Cutting Research | Small Business Programs | NINDS | 1910 GENETICS, INC. | NWANKWO, JENNIFER | Cambridge, MA | 2021 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: NS-20-011 Summary: The need to develop non-opioid therapeutics for chronic pain is greater than ever. One option being explored is inhibiting the activity of calpains – enzymes that have been shown to cause pain in animal models of chronic pain. Using an artificial intelligence (AI)-driven drug discovery platform, researchers have uncovered and validated four calpain-1 inhibitors using biochemical assays. This study by 1910 Genetics Inc. hopes to synthesize multiple analogs of its most potent discovered calpain-1 inhibitor and determine its effectiveness against calpain-2 and certain enzymes that break down proteins. Findings that successfully significantly inhibit calpain-1 in at least one animal model of chronic pain could lead to the first oral, central nervous system penetrating selective calpain-1 inhibitor [non-opioid therapeutic] for chronic pain. |
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1R44NS125745-01A1
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Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) | Cross-Cutting Research | Small Business Programs | NINDS | EVON MEDICS, LLC | NWAOKOBIA, CHARLES CHIEDU (contact); NWULIA, EVARISTUS A | Elkridge, MD | 2022 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010 Summary: Research shows that individuals with chronic pain may experience brain changes that contribute to anxiety, depression, and cognitive impairment. This project will test a user-friendly, home-based device to treat chronic pain. The device stimulates the brain through olfactory training: repetitive daily stimulation with specific smells. The research will optimize a treatment approach and test the device in a clinical study. |
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R41DA055405-01
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Virtual Reality Facilitation of Recovery from Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | Relate XR LLC | OBERLIN, BRANDON G (contact); NELSON, ANDREW | Indianapolis, IN | 2022 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-020 Summary: Relapse is common in people with opioid use disorder, and recovery attempts often fail within 6 months. This research project will test a novel virtual reality intervention to improve recovery outcomes for people recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes. |
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1R44DA058531-01
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BoostPrime, A Novel Digital Therapeutic for Craving Mitigation in Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | NXTECH, INC. | PATEL, SALIL | Patchogue, NY | 2023 |
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-021 Summary: Cravings and impulsivity are key contributors that lead people to return to opioid misuse, but are not addressed by currently available treatments and tools. This project will develop and validate BoostPrime, a customized digital therapeutic software tool that delivers novel cognitive training exercises. The tool aims to help address cravings and strengthen momentary self-control for people with opioid use disorder by incorporating. |
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2R44DA044062-02
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LEVERAGING PREDICTIVE ANALYTICS WITHIN SOCIAL NETWORKS TO MAXIMIZE DRUG ANDALCOHOL TREATMENT EFFICACY AND RELAPSE PREVENTION | Cross-Cutting Research | Small Business Programs | NIDA | Sober Grid | Pesce, Christopher Neil | Boston, MA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573 Summary: Sober Grid™ has developed a smartphone-based mobile application currently in use by more than 120,000 individuals worldwide who are in, or seeking, recovery from drug and alcohol addiction. The “Grid,” as it is known, is a mobile-based, social recovery community providing rapid context-specific peer support, efficient help seeking, motivational enhancement exercises, and member ratings of support content—all aimed to prevent relapse. The overarching goal of this phase II project is to extend the current capabilities of the Sober Grid app to achieve a comprehensive social recovery support app featuring intelligent, context-appropriate resource matching and 24/7 rapid-response peer coaching that is effective in reducing disordered substance use and is cost-effective. This projects tests whether providing this functionality to high-risk members will be acceptable, feasible, increase access to and engagement with resources, and have a positive effect in increasing time to relapse and days of consecutive abstinence. |
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R44DA056280-01
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Reducing Opioid Use and Adverse Effects through Proactive Precision Pain Management Following Spine Surgery | Cross-Cutting Research | Small Business Programs | NIDA | Opalgenix, Inc. | PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR | Carmel, IN | 2022 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: Lumbar spinal surgery, an increasingly common surgery in adults with severe chronic back pain, is associated with acute post-surgical pain, costly postoperative opioid-related adverse effects, long hospital stays, high-risk for chronic post-surgical back pain, and persistent opioid use and dependence. Each individual responds differently to opioids based on their unique genetic and clinical factors, and the current trial-and-error approach to opioid use and prescribing promotes excessive opioid use, costly adverse outcomes, and poor surgical pain management. To address this issue, this research project will develop a preoperative diagnostic test that will use genetic and clinical information to proactively assess each person’s risk for opioid-related adverse events and chronic post-operative pain. The results will help clinicians provide personalized pain management to maximize pain relief while minimizing opioid-related safety risks, including opioid dependence. |
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1R43HL167661-01A1
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Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions | Cross-Cutting Research | Small Business Programs | NHLBI | OPALGENIX, INC. | PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR | Indianapolis, IN | 2023 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 |
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1R43HL167661-01A1
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Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions | Cross-Cutting Research | Small Business Programs | NHLBI | OPALGENIX, INC. | PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR | Carmel, IN | 2023 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery. |
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1R43DA058430-01
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Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy | Cross-Cutting Research | Small Business Programs | NIDA | OPALGENIX, INC. | PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR | Carmel, IN | 2023 |
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-021 Summary: There is an urgent and unmet clinical need for a reliable technology to prevent maternal opioid use relapse and neonatal opioid withdrawal syndrome (NOWS) in their infants. This project aims to assess risk for these outcomes based on individual genetic and clinical factors. The research will expand previous studies of genetic and clinical predictors of opioid-related adverse outcomes. The goal is to develop a risk predictor algorithm and software tool for use in an electronic health record, toward personalized risk assessment and prevention of maternal relapse and NOWS. |
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2R44NS115460-02
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Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches | Cross-Cutting Research | Small Business Programs | NINDS | THERMAQUIL, INC. | POPIELARSKI, STEPHEN (contact); YUAN, HSIANGKUO | Philadelphia, PA | 2021 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010 Summary: Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks. |
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1R44DA050357-01
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An optimized screening platform for identifying and quantifying biased agonists as drugs for the treatment of Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | MONTANA MOLECULAR, LLC | QUINN, ANNE MARIE (contact); HUGHES, THOMAS E | Bozeman, MT | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: As the opioid crisis claims more and more lives, there is a need to develop new, safer analgesics. Biased agonists could activate beneficial signaling pathways while avoiding those that cause adverse effects. This project aims to speed the discovery of non-addictive analgesics by providing drug discovery teams with simpler, more robust, more quantitative assays for agonist bias. The goal is to optimize and test new assays for agonist bias at NOP, D3 dopamine, CB1 cannabinoid, and OPRM1 opioid receptors, which couple to both the Gi and ?-arrestin signaling pathway, and create new tools to improve the analysis of structure/activity relationships that can be used in drug discovery and distribute to researchers who are developing new drugs for OUD. |
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1R44DA058474-01
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Development of the OpiAID Strength Band Platform | Cross-Cutting Research | Small Business Programs | NIDA | OPIAID, INC. | REESER, DAVID (contact); MACQUEEN, DAVID ALDERSON; WASHINGTON, WENDY DONLIN | Wilmington, NC | 2023 |
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-021 Summary: Although medications for opioid use disorder are effective and available, providers currently lack methods to monitor patients and thus inform improved dosing. This project will develop Strength Band Platform, an innovative artificial intelligence-based digital platform. The wearable device will collect patient physiological characteristics to detect relapse and withdrawal during treatment with medications for opioid use disorder in real-world settings. |
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1R43NS120335-01
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Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain | Cross-Cutting Research | Small Business Programs | NINDS | QUANTUM NANOSTIM | REILLY, THOMAS | Treasure Island, FL | 2021 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain. |
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1R44DA046151-01
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RAE (REALIZE, ANALYZE, ENGAGE)- A DIGITAL BIOMARKER BASED DETECTION AND INTERVENTION SYSTEM FOR STRESS AND CRAVING DURING RECOVERY FROM SUBSTANCE ABUSE DISORDERS | Cross-Cutting Research | Small Business Programs | NIDA | ContinueYou, LLC | Reinhardt, Megan Rois | Bristol, ME | 2019 |
NOFO Title: Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
NOFO Number: RFA-DA-18-010 Summary: For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individual’s support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse. |
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1R43NS120617-01A1
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Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials | Cross-Cutting Research | Small Business Programs | NINDS | PLUMERIA THERAPEUTICS, INC. | RICHARDSON, THOMAS P (contact); WANG, YIPING | Plainsboro, NJ | 2021 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor. |
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1R43DA047722-01
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PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR PAIN | Cross-Cutting Research | Small Business Programs | NIDA | Peptide Logic, LLC | Riviere, Pierre | SAN DIEGO, CA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drug’s efficacy and reducing potential side effects, and test the resulting molecule in animal models. |
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2R44DA045410-02
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Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain | Cross-Cutting Research | Small Business Programs | NIDA | PEPTIDE LOGIC, LLC | RIVIERE, PIERRE | San Diego, CA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy. Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development, validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies. |
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1R43DA050380-01
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Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy | Cross-Cutting Research | Small Business Programs | NIDA | QUASAR, INC. | ROBERTS, BROOKE | San Diego, CA | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that an NF training in VR would have synergistic effects, as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP), as this is a growing segment of chronic pain sufferers with a 39 percent worldwide lifetime prevalence, and whose sufferers have historically been heavy users of opiates; later stages of this project will expand this application to address other forms of pain. |
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1R44NS113749-01
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Micronized salsalate in a parenteral formulation is a safe and effective analgesic for acute postoperative pain management | Cross-Cutting Research | Small Business Programs | NINDS | RH NANOPHARMACUETICALS L.L.C. | ROSS, JOEL STEVEN | Monmouth Beach, NJ | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: There is an unmet need for an effective parenteral/oral analgesic for acute post- operative pain management without the risks of opioid addiction. Salsalate, a dimer or salicylic acid, is currently available in oral dosage for the treatment of osteoarthritis and rheumatoid arthritis. Salsalate works at multiple levels to target multiple steps along the surgical pain pathway. Salsalate through its active metabolite, salicylic acid (SA), reduces NF-?B activation via IKK-kinase beta inhibition, and has no direct binding to cyclooxygenase 1 (Cox-1); therefore, does not affect function of platelets, resulting in a safer hematological and gastrointestinal safety profile. RH Nano proposes a plan for manufacturing and pre- clinical testing of parenteral M-salsalate in two animal models to assess the efficacy and safety in the treatment of acute postoperative pain management. In this proposal, the team will develop the optimal formulation under strict Chemistry Manufacturing and Control guidelines. In Phase II, the team proposes to conduct the pharmacokinetics and toxicology studies of M-salsalate in two species of animals (rodent and non-rodent). Additionally, the project will use an animal pain model for preclinical efficacy studies, and an in vivo Receptor Occupancy assay in animal brain tissues to assess the opioid sparing properties of M-salsalate. |
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1R43NS124421-01A1
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Development of Nav1.7 Monoclonal Antibodies for Treating Pain | Cross-Cutting Research | Small Business Programs | NINDS | INTEGRAL MOLECULAR | RUCKER, JOSEPH BENJAMIN | Philadelphia, PA | 2021 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Many current pain relief treatments rely on use of opioid drugs. This research is conducting preclinical development on a non-addictive, non-opioid therapeutic that uses antibodies to target the sodium channel Nav1.7. This channel is known to be one of the primary routes for generating pain signals – thus it is a target for reducing pain. The antibody approach offers potential for greater specificity than small molecule approaches, potentially resulting in fewer side effects. |
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1R43DA050349-01
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A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence | Cross-Cutting Research | Small Business Programs | NIDA | CREATIVE BIO-PEPTIDES, INC. | RUFF, MICHAEL | Potomac, MD | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction—giving them a central role at the crossroads of chronic pain and the opioid crisis. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse. |
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2R44DA050349-02
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Development of a Novel Chemokine Receptor Antagonist as a Treatment for Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | CREATIVE BIO-PEPTIDES, INC. | RUFF, MICHAEL R | Potomac, MD | 2021 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction, giving them a central role at the crossroads of chronic pain and the opioid crisis. Blocking chemokines (rather than opioid receptors) provides an exciting treatment opportunity for both pain and opioid use disorder. This research continues previous work studying the efficacy of RAP-103, a small, orally stable chemokine receptor blocker. The previous research has shown that RAP-103 is safety and effective in preclinical models that mimic human drug-taking. This research will now optimize the dose required to achieve decreased motivation to maintain opioid use, establish manufacturing scale-up feasibility, provide RAP-103 for safety testing in animals, and conduct stability testing of RAP-103 toward the goal of submitting an Investigational New Drug application to the FDA. |