Gilgamesh Announces Clinical Candidates for Two Programs with First-in-Human Dosing Beginning in Late 2022

New treatments for depression and other neuropsychiatric disorders

NEW YORK, March 24, 2022 /PRNewswire/ — Gilgamesh Pharmaceuticals, a mental health-focused biotech company developing novel drugs related to psychedelics, today announced the appointment of two lead clinical candidates for the treatment of debilitating neuropsychiatric disorders such as depression, anxiety, PTSD and substance use disorders.

The first clinical candidate, GM1020, is an orally bioavailable, non-competitive N-methyl-D-aspartate receptor antagonist with the potential for rapid and sustained antidepressant activity. GM1020 is expected to have a favorable side effect profile allowing for potential home use.

The second clinical candidate, GM2505, is a new, fast-acting, short-acting 5HT2A agonist and 5HT releaser that is expected to have rapid therapeutic effect in a wide range of psychiatric disorders that includes the properties of both classic psychedelic DMT and of the empathogen MDMA. The optimized pharmacokinetic profile of GM2505 enables convenient and economical treatment. GM1020 and GM2505 will soon complete IND-enabling toxicology studies with Phase 1 trials expected to begin in the second half of 2022.

Additionally, Gilgamesh is pleased to announce a partnership with Colombia University to study and expand its extensive library of ibogaine analogs. Gilgamesh will continue to characterize these compounds and expects to nominate a lead candidate with improved potency and cardiovascular safety profile later in 2022.

“We have made significant progress with our core programs, generated and filed new IP, built a world-class team, and established key academic partnerships with Harvard and NYU which will serve as the core of our scientific platform. Gilgamesh has a uniquely innovative pipeline of innovative and transformational medicines that will improve the lives of people with debilitating neuropsychiatric disorders,” said CEO and co-founder Dr. Jonathan Sport.

“The pharmaceutical industry and the way we treat depression and substance abuse disorders will be revolutionized by advances in psychedelic medicine. Thanks to the tireless work of companies like Gilgamesh, researchers are demonstrating that psychedelic compounds have the potential not only treat mental health issues, but also be disease-modifying or potentially curative,” said Amy Kruse, Prime Movers Lab General Partner and Gilgamesh Board Member. “These candidates represent hope and real progress in the race to cure the hundreds of millions of people around the world suffering from mental health problems.

About Gilgamesh Pharmaceuticals

Gilgamesh is a pioneering biotechnology company focused on mental health sciences. We are focused on developing innovative new chemical entities (NCEs) by leveraging a unique combination of medicinal chemistry, intellectual property strategy, neuroscience and neurobiology, and drug development expertise. We are an experienced team, with proven success in biotech releases and inventions. For more information visit: www.gilgameshpharmaceutical.com.

Contact: Gavin Mathis406-539-7277

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SOURCEGilgamesh Pharmaceuticals