|Project #||Project Title||Research Focus Area||Research Program||Administering IC(s)||Institution(s)||Investigator(s)||Location(s)||Year Awarded|
|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
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.