Gilgamesh Announces Clinical Candidates For Two Programs With First In Human Dosing to Begin in Late 2022

Novel treatments for depression and other neuropsychiatric disorders

NEW YORK, March 24, 2022 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a mental health-focused biotechnology company developing novel psychedelic-related medicines, today announced the nomination 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 at-home use.

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

In addition, Gilgamesh is pleased to announce a partnership with Columbia University to investigate and develop its extensive library of ibogaine analogs. Gilgamesh will continue characterizing these compounds and plans to nominate a lead candidate with improved potency and cardiovascular safety profile later in 2022.

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

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

About Gilgamesh Pharmaceuticals

Gilgamesh is a pioneering mental health science-focused, biotechnology company. We have a disciplined focus on developing innovative new chemical entities (NCE's) leveraging a unique combination of medicinal chemistry, intellectual property strategy, neuroscience & neurobiology, and drug development expertise. We are an experienced team, with proven success in biotech exits and inventions. For more information, visit: www.gilgameshpharmaceutical.com.

Contact: Gavin Mathis, 406-539-7277

SOURCE Gilgamesh Pharmaceuticals