Subjective effects reached a peak intensity consistent with a full psychedelic experience, Gilgamesh noted, while the duration of those effects was limited to 60 to 90 minutes.
Gilgamesh Pharmaceuticals recently announced the successful completion of its Phase 1 Single Ascending Dose (SAD) trial of GM-2505, a novel 5-HT2A receptor agonist.
In the Phase 1 study, GM-2505 exhibited dose-proportional PK and dose-dependent effects on multiple pharmacodynamic measures, including subjective effects, electroencephalogram and neuroendocrine markers, according to the company.
Subjective effects reached a peak intensity consistent with a full psychedelic experience, Gilgamesh noted, while the duration of those effects was limited to 60 to 90 minutes.
“We were thrilled to obtain clinical confirmation of the short half-life and strong psychedelic effects of GM-2505 that were suggested by preclinical data and look forward to advancing this promising therapeutic candidate into patients,” said Andrew Kruegel, co-founder of Gilgamesh.
Gilgamesh initially developed GM-2505 for treatment-resistant depression and major depressive disorder (MDD). However, as R&D has progressed, the company has come to the conclusion that the drug “has the potential to enhance patient care and outcomes as a rapid-acting, durable, safe and intermittent therapeutic option across a broad range of other severe mental-health disorders, such as alcohol-use disorder, anxiety disorders and obsessive-compulsive disorder.”
“The successful completion of our GM-2505 Phase 1 SAD trial marks another significant milestone for Gilgamesh Pharmaceuticals,” Gilgamesh founder and CEO Jonathan Sporn said. “The progress across our pipeline shows that we are entering a new era of accessible, rapid-acting, intermittent and effective treatment options for mental health care.”
In a news release, the company said it “believes that GM-2505’s short duration of action will harness the impressive clinical efficacy of other 5-HT2A receptor agonists while better aligning with existing health care infrastructure and clinical workflow, which will broaden patient access [in] contrast to longer-acting agents such as psilocybin.”
On the heels of the Phase 1 SAD trial, Gilgamesh said it will initiate a Phase 2a study in MDD patients during the first quarter of 2024. The aim of the Phase 2a study will be to refine the dosing regimen, confirm safety and demonstrate an early efficacy signal of GM-2505.