Pharma Focus Europe

Gilgamesh Pharmaceuticals Achieves Success in Phase 1 SAD/MAD Clinical Trials for GM-1020

Friday, September 22, 2023

Gilgamesh Pharma is delighted to announce the successful completion of its Phase 1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trials for GM-1020, a novel oral small-molecule NMDA receptor channel blocker currently undergoing clinical development. This promising therapy has the potential to transform the treatment landscape for major depression, bipolar disorder, obsessive-compulsive disorder (OCD), and other debilitating mental health conditions.

GM-1020 stands out from existing ketamine-based therapies due to its convenient oral formulation, which offers over 60% oral bioavailability. Additionally, its pharmacokinetics (PK) demonstrate dose proportionality with a low coefficient of variation of approximately 20% (CV), along with dose-dependent subjective effects. Extensive pre-clinical data, supported by Phase 1 EEG and other biomarker studies, validate the expected efficacy of GM-1020 at non-dissociative doses. This innovative therapy builds upon the foundation of existing ketamine treatments and offers the potential for a convenient, well-tolerated, and home-based treatment option. Further details about the trials will be presented at the upcoming ACNP conference in December.

Dr. Maurizio Fava, Psychiatrist-In-Chief at the Department of Psychiatry, Massachusetts General Hospital, and Associate Dean for Clinical and Translational Research at Harvard Medical School, expressed optimism about GM-1020: "GM-1020 is a novel oral NMDA receptor antagonist with the potential to provide a new treatment option for patients with major depressive disorders and other neuropsychiatric conditions."

Following the successful completion of the Phase 1 SAD/MAD trials, Gilgamesh Pharma plans to initiate a Phase 2a study focused on patients with major depressive disorder (MDD) in the latter half of 2023. The objectives of the Phase 2a study include refining the dosing regimen, confirming safety, and demonstrating early signs of efficacy for GM-1020.

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

Jonathan Sporn, CEO and Founder of Gilgamesh, emphasized the significance of this milestone: "The successful completion of our Phase 1a SAD/MAD trials marks a significant achievement for Gilgamesh Pharma and the mental health community. GM-1020's unique properties hold immense promise for millions of patients suffering from mental health conditions, ushering in a new era of accessible, effective, and transformative treatment options."

With a team of experienced biotech professionals and visionary entrepreneurs, Gilgamesh Pharma possesses a wealth of expertise spanning medicinal chemistry, neurobiology, translational science, clinical research, and commercial development. Leveraging this collective experience, the company is well-prepared to advance GM-1020 through the development pipeline, ultimately bringing this life-changing therapy to patients in need.

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