In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on site initiations, dosing completion and clinical site partnerships.
CLEARMIND COMPLETES SITE INITIATIONS FOR AUD TRIAL: Clearmind Medicine (CMND) announced Wednesday the initiation of its U.S. clinical trial site at the Yale School of Medicine’s Department of Psychiatry. With this initiation, the company has now activated all planned sites for its Phase I/IIa clinical trial in Alcohol Use Disorder and can begin patient enrollment. Clearmind has completed all necessary preparations for the clinical trial, including obtaining Investigational New Drug approval from the U.S. Food and Drug Administration, Institutional Review Board approvals from each clinical site, launch of its Electronic Data Capture system to support the clinical trial and the arrival of its drug candidate, CMND-100, into the United States following manufacturing. The trial in Yale School of Medicine’s Department of Psychiatry will be led by Dr. Anahita Bassir Nia. The trial will also be conducted at the Johns Hopkins University School of Medicine in the U.S. and at the IMCA Center in Israel.
“AUD remains one of the most urgent and underserved public health challenges globally,” said Dr. Adi Zuloff-Shani, CEO. “With millions affected and current treatments often falling short, the study initiation for our FDA-approved CMND-100 trial marks a critical step toward potentially transforming the treatment landscape for alcoholism. We are honored to collaborate with world renowned institutions such as Yale and Johns Hopkins as we advance our mission to potentially provide safe, effective, and innovative solutions for individuals those suffering from alcoholism.”
COMPASS COMPLETES DOSING FOR PART A OF PHASE 3 TRIAL: Compass Pathways (CMPS) announced Tuesday that all participants have completed dosing in Part A of the COMP005 phase 3 trial for treatment resistant depression. Following pre-dosing activities, including washout from anti-depressant medications, if needed, participants received a single dose of either 25 mg of COMP360 or placebo. The company is on track to disclose top-line 6-week primary endpoint results in late June. The COMP005 trial is a multi-center study of an investigational, synthesized psilocybin for the treatment of TRD. In this randomized, double-blinded, placebo-controlled study, 258 participants with moderate-to-severe depression that have not responded to at least two or more prior treatments were dosed across 32 sites in the United States. This study aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD.
“Completing dosing of all participants in Part A of our 005 trial marks a critical milestone in our mission to address the pressing unmet need in treatment resistant depression,” said Kabir Nath, CEO. “We are proud of this achievement which reflects our team’s commitment to scientific rigor, operational excellence and potential to deliver a new treatment option to patients who have long been underserved. We are incredibly grateful to the participants, investigators and clinical sites that are making this study possible. We look forward to sharing the results of the 6-week primary endpoint in late June.”
CYBIN ENTERS CLINICAL SITE PARTNERSHIPS: Cybin (CYBN) announced Wednesday additional strategic partnership agreements, bringing the total to 18 clinical sites engaged to advance Cybin’s multinational Phase 3 program evaluating CYB003 for the adjunctive treatment of Major Depressive Disorder. The APPROACH study is expected to include approximately 45 clinical sites.
“This SPA model serves to take advantage of the deep expertise of each individual site and ensure that protocols and best practices are shared consistently,” said Doug Drysdale, CEO. “This level of cooperation will streamline trial operations and has the potential to reduce time to completion. We are especially pleased that Kimball Johnson, M.D., Medical Director of CenExel iResearch Atlanta, who served as the principal investigator for our successful Phase 1/2a CYB003 trial, and Paul Thielking, CSO, Cedar Clinical Research, are participating in the SPA program. Our SPA partners are experienced in neuropsychiatric drug trials and share Cybin’s deep commitment to the highest quality standards of investigational clinical work, and to developing safe and effective next-generation treatments to improve patient outcomes.”
Additionally on Monday, Cybin announced a strategic partnership with Osmind.
“Preparation for the commercialization of our clinical stage programs is a top priority, and aligning ourselves with Osmind will help us accelerate our goals,” said Drysdale. “Osmind’s extensive network of over 800 psychiatry clinics in the U.S., combined with our expertise, allows us to align on and prepare for the operational infrastructure needs relevant for interventional treatments.”
MIRA REPORTS IVR DATA FOR TOPICAL KETAMIR-2: MIRA Pharmaceuticals (MIRA) announced Wednesday the completion of in vitro release testing for its topical formulation of Ketamir-2. The formulation is under investigation for localized application in pain-related conditions. The IVRT study assessed a 5% ointment formulation of Ketamir-2 using a validated Franz diffusion cell model. The formulation demonstrated consistent and dose-proportional release across multiple concentrations. The active compound remained stable within a hydrophobic base, and testing parameters followed FDA-recommended guidance for topical product evaluation. MIRA is currently advancing preclinical studies to evaluate the topical formulation in models of inflammatory and neuropathic pain. The goal of these studies is to further characterize in vivo performance and inform potential clinical development strategies.
“As we continue expanding the Ketamir-2 program, we remain committed to building long-term shareholder value through strategic innovation and disciplined execution,” said Erez Aminov, CEO. “The ability to develop both oral and a localized topical formulation positions us to address a much broader segment of the pain market, which represents a significant commercial opportunity and a clear path for differentiation in a space that urgently needs safer, more targeted treatment options.”
OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM) Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).
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