The trial aims to evaluate the safety, tolerability, and efficacy of GM-1020 to treat major depressive disorder. Credit: ESB Professional / Shutterstock.

Gilgamesh Pharmaceuticals has commenced subject dosing in a Phase IIa clinical trial of GM-1020 to treat major depressive disorder (MDD).

This clinical trial aims to evaluate the safety, tolerability, and efficacy of GM-1020 given as single and multiple oral doses.

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The study is designed as a randomised, two-part, controlled trial, starting with an initial placebo-controlled crossover phase, followed by a two-week multiple-dose period.

Gilgamesh anticipates that initial data from the Phase IIa trial will be available in the second half of this year.

An orally bioavailable NMDA receptor antagonist, GM-1020 is claimed to enhance upon established NMDA receptor antagonists by combining their quick and strong clinical efficacy with oral dosing and an enhanced safety/tolerability profile. 

Gilgamesh founder and CEO Jonathan Sporn said: “Current treatments which block the serotonin transporter can take four to six weeks to show even a limited benefit and have significant and often limiting side effects, including blunted emotions, weight gain, sleep disturbance, and sexual dysfunction.”

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In addition to GM-1020, Gilgamesh is advancing another asset, GM-2505, through Phase II trials for MDD.

In March, the company received a substantial boost with a multi-year $14m grant from the US National Institute on Drug Abuse to develop GM-3009, a cardiac-safe ibogaine analogue for treating substance use disorders.

The grant will provide non-dilutive funding to back IND-enabling toxicology studies, GMP manufacturing, and execute Phase I/Ib clinical trials of GM-3009 in healthy volunteers and opioid use disorder patients.

In December 2023, Gilgamesh stated its plans to initiate a Phase IIa trial of GM-2505 in Q1 2024.