Gilgamesh Pharmaceuticals has been awarded a $14 million grant from the National Institute on Drug Abuse (NIDA) to support the development of GM-3009, a novel, cardiac-safe analog of ibogaine, for the treatment of opioid use disorder (OUD). The funding will facilitate IND-enabling toxicology studies, GMP manufacturing, and Phase 1/1b clinical trials. These trials will evaluate the safety profile of GM-3009, specifically addressing the cardiovascular risks associated with ibogaine, and assess its efficacy in alleviating OUD symptoms.
Addressing Ibogaine's Cardiovascular Risks
Ibogaine, a psychoactive compound derived from plants, has shown promise in treating substance use disorders. However, its clinical development has been hampered by significant cardiovascular toxicity. GM-3009 is designed to eliminate these risks while preserving or enhancing ibogaine's therapeutic effects.
Clinical Development and Potential Impact
The planned Phase 1/1b trials will involve healthy volunteers and patients with OUD. The primary goal is to confirm the improved cardiovascular safety profile of GM-3009 and to demonstrate preliminary efficacy in reducing OUD symptoms. Successful completion of these early-stage studies will pave the way for larger Phase 2 efficacy trials.
Jonathan Sporn, CEO of Gilgamesh, emphasized the importance of the grant, stating, "Receiving this grant from NIDA is an important endorsement of Gilgamesh's scientific rigor and commitment to addressing one of the most pressing public health crises of our time... NIDA is facilitating the translation of innovative scientific research into tangible treatments that can significantly impact public health."
Novel Ibogaine Analogs
GM-3009 is part of a library of over 200 ibogaine analogs developed by Gilgamesh founders Andrew Kruegel and Dalibor Sames, Professor of Chemistry at Columbia University, and licensed from Columbia. This extensive research effort aims to identify compounds with improved safety and efficacy profiles compared to ibogaine.
The Opioid Epidemic
The development of GM-3009 is particularly timely given the ongoing opioid epidemic, which claimed the lives of over 100,000 Americans in 2023. There is a critical need for rapid-acting, effective, and safe treatments for OUD. GM-3009 has the potential to revolutionize OUD treatment by offering a safer and potentially more effective alternative to existing therapies.
