Fed Agency Grants $14M To Gilgamesh For Cardiac-Safe Ibogaine Analog Targeting Opioid Use Disorder

Clinical-stage neuroscience company Gilgamesh Pharmaceuticals has been awarded a multi-year $14 million grant from the National Institute on Drug Abuse (NIDA) to develop GM-3009, a novel, reportedly cardiac-safe ibogaine analog for the treatment of substance use disorders. 

As recently reported in the York Times, the plant-derived psychoactive compound ibogaine holds accumulated data from trials and case reports that point to its robust efficacy as a treatment for substance use disorders. 

(See 2024 Stanford study on ibogaine therapy showing promising outcomes for veterans with trauma brain injury.)

Nonetheless, ibogaine's pharmaceutical development has been hindered by its significant cardiovascular toxicity. 

This is where the federal grant comes in by providing funding to support IND-enabling toxicology studies, GMP manufacturing and Phase 1/1b clinical trials in healthy volunteers and Opioid Use Disorder (OUD) patients for GM-3009. 

Potential Impact

In the developers’ words, "GM-3009 represents a potential pivotal advance in the fight against the opioid epidemic, which claimed the lives of more than 100,000 Americans in 2023, as a rapid-acting, effective, durable, and safe treatment." 

Gilgamesh’s novel approach is believed to mitigate the known cardiovascular risks of ibogaine, while potentially increasing its efficacy to the point where it may transform OUD treatment.

The planned clinical work aims to confirm that GM-3009 eliminates the cardiovascular risks associated with ibogaine and to show proof-of-concept efficacy in attenuating symptoms associated with OUD. 

Following completion of the funded development, GM-3009 would be set to enter larger Phase 2 efficacy studies.

Gilgamesh CEO Jonathan Sporn views the NIDA grant as "an important endorsement of the company's scientific rigor and commitment to addressing one of the most pressing public health crises of our time." 

Sporn says that by funding the early-stage studies, the federal agency "is facilitating the translation of innovative scientific research into tangible treatments that can significantly impact public health.”

Gilgamesh's Work

GM-3009 is part of a library of reportedly 200+ ibogaine analogs from multiple scaffolds developed by Gilgamesh founders Andrew Kruegel and Dalibor Sames, Professor of Chemistry at Columbia University, and licensed from Columbia.

As a clinical-stage biotech developing innovative new chemical entities (NCEs) that target the root causes of neurological diseases, Gilgamesh's compounds aim to move away from symptom management and toward rapid-acting and long-lasting therapies. Its designed best-in-class NCEs act through proven mechanisms, which are optimized for safety, efficacy and patient access. 

The company's two lead clinical programs, GM-1020 and GM-2505 have begun Phase 2 studies in Major Depressive Disorder (MDD.)

The company’s goal is to move toward a new era in addiction treatment marked by safer, more effective and scientifically validated therapies.

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