Gilgamesh Receives Grant To Combat Opioid Dependency

Gilgamesh Pharmaceuticals, located in New York, has recently received a significant financial boost with a $14 million grant from the National Institute on Drug Abuse (NIDA). This funding is set to propel the development of GM-3009, a novel substance engineered as a safer substitute to ibogaine, aiming to revolutionize the treatment of substance use disorders, with a keen focus on combating opioid dependency.

This innovative compound, GM-3009, is Gilgamesh’s brainchild, crafted to minimize the cardiovascular dangers tied to ibogaine, thereby offering a promising new direction in the treatment landscape. The generous grant from NIDA will facilitate the progression of GM-3009 through the necessary IND-enabling toxicology investigations and the initial Phase 1/1b clinical trials.

“The grant from NIDA not only acknowledges our scientific diligence and dedication to confronting a critical public health challenge but also propels us closer to transforming cutting-edge scientific discoveries into practical solutions that could vastly improve public health outcomes.”

– Jonathan Sporn, CEO of Gilgamesh Pharmaceuticals

Ibogaine, the substance that GM-3009 aims to replace, is derived from the root bark of the Tabernanthe iboga shrub native to Africa, renowned for its psychoactive effects, including altered states of perception, mood, and consciousness. Historically utilized in spiritual rituals within certain African cultures, ibogaine has garnered interest in the West as a potential addiction treatment, particularly for opioids, due to anecdotal evidence suggesting its ability to lessen withdrawal symptoms and curb cravings. Nonetheless, its adoption has been hindered by safety concerns, notably the risk of cardiac complications and other severe adverse effects.

The upcoming trials for GM-3009 seek to establish its safety and efficacy in alleviating opioid use disorder symptoms. Success in these studies could mark a significant step forward, potentially leading to larger Phase 2 trials and, ultimately, bringing this innovative treatment closer to regulatory approval and widespread availability.

Gilgamesh Pharmaceuticals emphasized the potential of GM-3009 as a groundbreaking solution in the ongoing battle against the opioid crisis, which has devastatingly claimed over 100,000 lives in the United States in 2023 alone. The company highlighted the drug’s potential to offer a rapid, effective, durable, and safe therapeutic option.

With a research portfolio that boasts over 200 ibogaine analogs, Gilgamesh Pharmaceuticals stands at the forefront of developing alternative treatments that could fundamentally alter the approach to addressing substance use disorders, offering hope for a future with more effective and safer treatment options.