Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s) Sort descending	Investigator(s)	Location(s)	Year Awarded
1R41NS118992-01 Show Summary	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.
1R44GM140795-01A1 Show Summary	Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh	Cross-Cutting Research	Small Business Programs	NIGMS	21MEDTECH, LLC	ALFARO, ARTHUR	Durham, NC	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: There is an urgent need for non-opioid post-operative pain management solutions. This research is developing a naturally absorbable polymer film that can release controlled amounts of the non-opioid analgesic bupivacaine – aiming to manage pain for several days following surgery. Project objectives are to optimize the timing of drug release, develop manufacturing standards, determine effective dosage for preserving motor function, and determine safety and efficacy in mouse models of neuropathic pain. Continued development of this film delivery system may lead to a new, non-opioid therapeutic strategy that could be combined with local anesthesia for up to 4 days after surgery to reduce or potentially eliminate opioids use.
1U44NS115692-01 Show Summary	Development and Optimization of MNK Inhibitors for the Treatment of Neuropathic Pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	4E THERAPEUTICS INC.	SAHN, JAMES JEFFREY	Austin, TX	2019
NOFO Title: HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-020 Summary: MNK-eIF4E signaling is activated in nociceptors upon exposure to pain or peripheral nerve injury, promoting cytokines and growth factors and increasing nociceptor excitability, which leads to neuropathic pain. Genetic or pharmacological inhibition of MNK signaling blocks and reverses nociceptor hyperexcitability as well as behavioral signs of neuropathic pain. A clinical phase drug for cancer shows strong specificity as an MNK inhibitor but requires optimization because MNK inhibition in the central nervous system (CNS) may lead to depression, an unacceptable side effect for a neuropathic pain drug. The research team plans a targeted medicinal chemistry and screening campaign directed at generating a MNK-inhibitor-based neuropathic pain treatment with the goal of restricting its CNS penetration while retaining potency, specificity, and in vivo bioavailability and efficacy.
3U44NS115692-01S1 Show Summary	Development and Optimization of MNK Inhibitors for the Treatment of Neuropathic Pain	Preclinical and Translational Research in Pain Management	Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain	NINDS	4E THERAPEUTICS INC.	SAHN, JAMES JEFFREY	Austin, TX	2020
NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome NOFO Number: NOT-TR-20-008 Summary: There is an urgent unmet need for more efficacious analgesics that act via a non-opioid pathway. Mitogen Activated Protein Kinase-interacting kinase 2 (MNK2) is an enzyme that has been implicated in pain signaling, and there is compelling evidence that inhibiting MNK2 has significant pain-reducing effects with few side-effects. Since MNK2 selective inhibitors have not yet been identified, selective inhibition of MNK2 with a small molecule has not been possible. The development of such compounds will enable studies that will illuminate key differences between MNK2 and MNK1. More importantly, from a therapeutic standpoint, highly selective MNK2 inhibitors may prove to have enhanced efficacy and a more favorable side-effect profile than molecules that inhibit both MNK2 and MNK1. This project will support the design and synthesis of at least one MNK2 inhibitor, with >100-fold selectivity over MNK1, that may be developed into a lead compound for treating neuropathic pain.
1R43NS110117-01 Show Summary	Development of a novel anti-migraine therapeutics	Cross-Cutting Research	Small Business Programs	NINDS	ADEPTHERA, LLC	HSU, SHEAU-YU TEDDY	Palo Alto, 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: New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents.