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Gilgamesh Pharmaceuticals Successfully Completes Phase 1 SAD/MAD Clinical Trials of GM-1020

Single and multiple oral doses of GM-1020, a novel non-competitive NMDA channel blocker, were well-tolerated with no serious or severe adverse events observed and confirmed target engagement via EEG.

NEW YORK, Sept. 21, 2023 /PRNewswire/ — Gilgamesh Pharma, a cutting-edge clinical-stage biotechnology company proudly announces the successful completion of its Phase 1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trials for GM-1020, the only novel oral, small-molecule NMDA receptor channel blocker currently in clinical development. This next-generation therapy is poised to potentially transform the treatment landscape for major depression, bipolar disorder, obsessive-compulsive disorder (OCD), and other debilitating mental health conditions.

GM-1020 distinguishes itself from existing ketamine-based therapies through its convenient oral formulation (>60% oral bioavailability), dose proportional pharmacokinetics (PK) with ~20% CV, dose dependent subjective effects and expected efficacy at non-dissociative doses based on extensive pre-clinical data and supported by Phase 1 EEG and other biomarkers. This pioneering therapy builds on the foundation laid by existing ketamine treatments, offering the potential for a convenient, well-tolerated, and home-based treatment option. Additional details to be presented at ACNP in December.

“GM-1020 is a novel, oral NMDA receptor antagonist with the potential of advancing a new treatment option for patients with major depressive disorders and other neuropsychiatric conditions,” says Maurizio Fava, Psychiatrist-In-Chief, Department of Psychiatry, Massachusetts General Hospital, and Associate Dean for Clinical and Translational Research, Harvard Medical School.

Following the successful completion of the Phase 1 SAD/MAD trials, Gilgamesh Pharma will initiate a Phase 2a study in major depressive disorder (MDD) patients during the second half of 2023. The aim of the Phase 2a study will be to refine the dosing regimen, confirm safety, and demonstrate an early efficacy signal of GM-1020.

Gilgamesh Pharma is dedicated to revolutionizing mental health care by developing innovative new chemical entities (NCEs) that target the root causes of diseases, moving away from symptom management towards rapid-acting and long-lasting therapies.

“The successful completion of our Phase 1a SAD/MAD trials marks a significant milestone for Gilgamesh Pharma and the mental health community,” says Jonathan Sporn, CEO and Founder of Gilgamesh. “GM-1020’s unique properties hold immense promise for millions of patients suffering from mental health conditions, enabling a new era of accessible, effective, and transformative treatment options.”

Gilgamesh Pharma’s team of seasoned biotech veterans and innovative entrepreneurs boast a wealth of expertise spanning medicinal chemistry, neurobiology, translational science, clinical research, and commercial development. With their collective experience, the company is well-equipped to usher GM-1020 through the development pipeline and ultimately bring this life-changing therapy to patients in need.

About Gilgamesh Pharmaceuticals

Gilgamesh is a clinical-stage biotech focused on neuroscience aiming to fundamentally improve how mental illnesses are treated by shifting away from symptom management to a focus on rapid-acting and durable therapies targeting the fundamental drivers of disease. We do this by designing best-in-class new chemical entities (NCEs) acting through proven mechanisms, which are optimized for safety, efficacy, and patient access. The Gilgamesh team brings together proven expertise in medicinal chemistry, neurobiology, translational science, clinical research, and commercial development. Our highly seasoned biotech veterans and proven entrepreneurs have the experience to ensure high quality and creative drug development to bring our new medicines rapidly and successfully to patients.

Gavin Mathis

SOURCE Gilgamesh Pharmaceuticals

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