Gilgamesh Pharma has completed the Phase I single ascending dose (SAD) and multiple ascending dose (MAD) trials of GM-1020 for the treatment of major depressive disorder (MDD) and other neuropsychiatric conditions.

GM-1020, a N-methyl-D-aspartate (NMDA) receptor channel blocker, was found to be well-tolerated in patients who received single and multiple oral doses during the study.

No serious or severe adverse events were reported, and the data confirmed evidence of target engagement through electroencephalogram (EEG).

Gilgamesh Pharma CEO and founder Jonathan Sporn said: “The successful completion of our Phase Ia SAD/MAD trials marks a significant milestone 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, enabling a new era of accessible, effective, and transformative treatment options.”

GM-1020 exhibited more than 60% oral bioavailability compared to existing ketamine-based therapies, based on the pre-clinical data and supported by Phase I EEG and other biomarkers.

The therapy also demonstrated dose proportional pharmacokinetics with approximately 20% CV and has dose dependent subjective effects with expected efficacy at non-dissociative doses.

The company also plans to commence a Phase IIa study in MDD patients in the second half of this year.

The objective of the study is to confirm safety, demonstrate an early efficacy signal, and determine the dosing regimen of GM-1020.