Description
The Advanced Research Projects Agency for Health (ARPA-H) is seeking proposals for the development of innovative treatments for serious mental illnesses, specifically opioid use disorder (OUD). The agency is interested in supporting the early clinical development of ibogaine, a psychoplastogen that has shown potential in improving OUD outcomes. Proposers are encouraged to submit solution summaries that include plans for developing and submitting an Investigational New Drug (IND) application for ibogaine, as well as developing a safe clinical protocol for Phase 1 clinical trials and procuring sufficient quantities of good manufacturing practice (GMP)-grade clinical material.
• Development of an IND application for ibogaine
• Development of a safe clinical protocol for Phase 1 clinical trials
• Procurement of GMP-grade clinical material
The proposers should also include a regulatory consultant with relevant expertise in psychoplastogen drug development and provide rough plans to maintain affordability and price transparency following advanced clinical development.