Funded Projects

Project # Project Title Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
1R44NS115196-01
A single dose long-acting non-addictive polymer conjugate formulation of buprenorphine that provides immediate and prolonged analgesia for post-operative pain Cross-Cutting Research Small Business Programs NINDS SERINA THERAPEUTICS, INC. VIEGAS, TACEY XAVIER; MOREADITH, RANDALL W Huntsville, AL 2019
FOA 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)
FOA Number: PA-18-574
Summary:

SER-227 is a long-acting polymer pro-drug of buprenorphine that is being developed to treat post- operative pain following major surgeries such as bunionectomy, abdominoplasty, thoracotomy and knee and hip surgery. The ultimate goal is to demonstrate that SER-227 can be manufactured and tested preclinically to show that it is safe for use in a Phase I clinical study. Aims include 1.SER-227 chemistry and process optimization to generate a technical package, 2. SER-227 manufactured under current Good Manufacturing Practices, 3. Evaluated in formal toxicology studies in rodent and non-rodent animals so that justifications can be made to support a ‘first-in-man’ study, and 4. Submission of an Investigational New Drug application (IND) along with a Phase I clinical  protocol in normal volunteers to measure the safety, tolerability and pharmacokinetics of  buprenorphine that is released from SER-227.