Gilgamesh describes GM-3009 as “a novel, cardiac-safe ibogaine analog” that could “revolutionize” the treatment of opioid-use disorder.
The National Institute on Drug Abuse has awarded a multi-year $14 million grant to Gilgamesh Pharmaceuticals for the company to develop GM-3009.
Gilgamesh, a clinical-stage neuroscience company, describes GM-3009 as “a novel, cardiac-safe ibogaine analog for the treatment of substance-use disorders.”
“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,” New York City-based Gilgamesh said in a news release. “Gilgamesh’s novel approach mitigates the known cardiovascular risks of ibogaine, while potentially increasing its efficacy. GM-3009 may revolutionize the treatment of [opioid-use disorder].”
The grant provides non-dilutive funding to support IND-enabling toxicology studies, GMP manufacturing and Phase 1/1B clinical trials in healthy volunteers and patients with opioid-use disorder, according to Gilgamesh.
The planned clinical work will seek to confirm that GM-3009 eliminates the cardiovascular risks associated with ibogaine and demonstrate proof-of-concept efficacy in attenuating symptoms associated with opioid-use disorder, the company noted.
Following completion of the funded development, GM-3009 will be ready to enter larger Phase 2 efficacy studies.
“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,” Gilgamesh CEO Jonathan Sporn said. “By funding these critical early-stage studies, NIDA is facilitating the translation of innovative scientific research into tangible treatments that can significantly impact public health.”
GM-3009 is part of a library of more than 200 ibogaine analogs from multiple scaffolds developed by Gilgamesh founders Andrew Kruegel and Dalibor Sames. Kruegel is a medicinal chemist; Sames is a professor of chemistry at Columbia University.
“Dr. Sames has deep expertise in the therapeutic effects of ibogaine, having researched compounds in this class for over 15 years,” said Beth Kauderer, senior technology licensing officer at Columbia Technology Ventures. “We are pleased this grant from NIDA will advance GM-3009 to the clinic, allowing the discoveries made by Dr. Sames to be one step closer to benefitting patients suffering from addiction.”