Gilgamesh Announces Initiation of Phase 2a Trial of GM-1020 in Major Depressive Disorder

• Patient dosing has been initiated with GM-1020, a novel oral NMDA receptor antagonist
• Initial results of the Phase 2a trial anticipated to be available in the 2^nd half of 2024

NEW YORK, May 1, 2024 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a clinical-stage neuroscience company committed to developing best-in-class, rapid-acting treatments for central nervous system disorders, today announced the initiation of patient dosing with GM-1020 in a Phase 2a study in Major Depressive Disorder (MDD) to assess safety, tolerability, and efficacy. GM-1020 is a novel, orally bioavailable NMDA receptor antagonist with reduced sedative and dissociative side effects. The study will include an initial placebo-controlled crossover phase followed by a 2-week multiple dose period.

Despite the widespread use of decades old SSRI/SNRIs the prevalence of severe depression continues to increase, harming not just patients, but their friends and family. This alarming trend highlights the urgent need for treatments that are faster, safer, and more widely accessible. "Current treatments which block the serotonin transporter can take 4-6 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," said Jonathan Sporn, Founder and CEO of Gilgamesh.

Gilgamesh believes that GM-1020 will provide much-needed innovation to address this unmet medical need. GM-1020's potentially best-in-class profile improves upon established NMDA receptor antagonists, such as ketamine and Spravato™, by combining their rapid and robust clinical efficacy with oral dosing and an improved safety/tolerability profile. These innovations should enable broader patient access, including the potential for at home use.

Further, like all Gilgamesh programs, GM-1020 is protected by composition of matter intellectual property (IP) rights. This level of patent protection will be essential to future partnerships with large pharmaceutical companies to bolster broad scale promotion and patient uptake. This approach stands in contrast to many competitors which focus on minor formulation tweaks of existing molecules resulting in less innovative clinical profiles and weaker IP.

About Gilgamesh Pharmaceuticals

Gilgamesh Pharmaceuticals is a clinical stage neuroscience biotech developing innovative, best-in-class new chemical entities (NCEs) that target the root causes of CNS diseases, moving away from symptom management towards rapid-acting and long-lasting therapies. We do this by designing best-in-class NCEs acting through proven mechanisms, which are optimized for safety, efficacy, and patient access. Currently, our flagship clinical programs, GM-1020 and GM-2505, are advancing through Phase 2 trials targeting Major Depressive Disorder, marking significant milestones in our commitment to pioneering rapid-acting and enduring therapies. Discover the full scope of Gilgamesh's therapeutic innovations at https://www.gilgameshpharmaceutical.com/.

Media: Gavin Mathis, [email protected]

Investors: Laszlo Kiss, [email protected]

SOURCE Gilgamesh Pharmaceuticals