Clearmind Medicine (CMND, Financial) has officially initiated its U.S. clinical trial site at Yale School of Medicine, marking a significant milestone in its Phase I/IIa trial focusing on Alcohol Use Disorder (AUD). This activation completes the setup of all planned sites, enabling the commencement of patient enrollment. The company has meticulously prepared for this trial, securing necessary approvals from the U.S. Food and Drug Administration (FDA) and Institutional Review Boards, and implementing an Electronic Data Capture system. The trial will evaluate the drug candidate CMND-100 across prestigious institutions including Johns Hopkins University and Israel’s IMCA Center.
In a parallel development, Compass Pathways (CMPS) announced the completion of dosing for Part A of its COMP005 phase 3 trial, targeting treatment-resistant depression (TRD). The study, conducted across 32 U.S. sites, tested a single dose of either 25 mg of COMP360 or a placebo on 258 participants. Results of the primary endpoint are anticipated in June.
Moreover, Cybin (CYBN) has expanded its clinical partnerships, now engaging 18 sites for its Phase 3 program evaluating CYB003 for Major Depressive Disorder. This strategic alliance aims to streamline trial operations and expedite completion. Additionally, Cybin has partnered with Osmind to bolster preparations for commercializing its clinical programs.
In other news, MIRA Pharmaceuticals (MIRA) reported completion of in vitro release testing for its Ketamir-2 topical formulation. This 5% ointment showed stable, dose-proportional release, and the formulation is under preclinical evaluation for pain-related conditions. MIRA aims to address the pain market with both oral and topical solutions, offering safer, targeted treatments.
The psychedelic stocks space continues to evolve with numerous companies like Algernon Pharmaceuticals (AGNPF) and Seelos Therapeutics (SEEL) seeking breakthroughs in mental health treatment.
