In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a clinical site initiation, an FDA authorization and an analyst initiation.
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CLEARMIND INITIATES U.S. SITE FOR CMND-100 TRIAL: Clearmind Medicine (CMND) announced Thursday that it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of Medicine. The first-in-human clinical trial will investigate the safety, tolerability and full pharmacokinetic profile of Clearmind’s treatment, CMND-100, in Alcohol Use Disorder patients. This study is the first clinical application of the company’s proprietary CMND-100 platform and marks a significant milestone in the company’s mission to provide innovative solutions for addictions, weight loss and mental health disorders such as depression and anxiety. The study will be led by the principal investigator, Jennifer Ellis, PhD, Associate Professor of Psychiatry and Behavioral Sciences, JHU School of Medicine and by co-investigator Professor Eric Strain, Director, Behavioral Pharmacology Research Unit, JHU School of Medicine.
Adi Zuloff-Shani, CEO, commented, “The initiation of our clinical trial at Johns Hopkins, one of the most respected research institutions in the world, is a significant step in our journey toward FDA approval. The involvement of such esteemed clinical sites in our clinical trial, reflects the growing recognition of CMND-100’s potential as a breakthrough treatment for AUD. With additional clinical sites launching the trial including Yale and IMCA in Israel, we are establishing a strong foundation to evaluate the clinical potential of our psychedelic-based therapeutic platform.”
The company also announced on Tuesday the publication of an international patent application in collaboration with Yissum Research Development Company of the Hebrew University of Jerusalem. The patent application covers psychedelic-based compounds designed for the treatment of mental health disorders and addiction.
FILAMENT REPORTS FDA AUTHORIZATION OF PHASE 2 TRIAL: Filament Health (FLHLF) announced Wednesday that the U.S. Food and Drug Administration has authorized a phase 2 clinical trial study of its lead drug candidate, PEX010, at the University of Pennsylvania. The trial will study the effects of psychedelic-assisted psychotherapy in the treatment of opioid use disorder, and is funded by the Wellcome Leap as part of its Untangling Addiction Program. Preliminary findings with PEX010 in alcohol use disorder have encouraged testing in the opioid domain. The studies with PEX010 in OUD will be an important initial step in determining the medication’s promise in addressing the opioid crisis. The clinical trial at the University of Pennsylvania will focus on the impact of PEX010 on clinical outcomes, with additional measures to help predict which patients may be most likely to benefit from this treatment option. The trial at the University of Pennsylvania is expected to begin dosing in by Q3.
“Opioid use disorder is a significant public health issue and a major contributor to the growing overdose crisis in North America,” said Dr. Anna Rose Childress, Director of the Brain-Behavioral Vulnerabilities Laboratory at the Perelman School of Medicine and Principal Investigator for the trial. “This trial will assess the safety and feasibility of delivering natural psilocybin in the treatment of OUD and evaluate potential changes in participants’ opioid use. We are grateful to Filament Health for facilitating this important research.”
ATAI LIFE SCIENCES INITIATED WITH POSITIVE RATING: On Friday, Berenberg initiated coverage of atai Life Sciences (ATAI) with a Positive rating. Atai has an “exciting” portfolio of psychedelic drug candidates that offer a novel approach to treating mental health disorders with high unmet need and large addressable populations, the analyst said. The firm added success for just one candidate could offer significant upside to the company’s current market cap.
ALGERNON RECEIVES NOTICE OF ALLOWANCE: Algernon Pharmaceuticals (AGNPF) announced Tuesday that it has received a notice of allowance from the European Patent Office for patent application 19827430.0 for its lead chronic kidney disease program drug NP-251. The invention claims the use of Repirinast, either alone or in combination with telmisartan, for the treatment or prophylaxis of renal fibrosis or kidney disease. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The company previously announced the allowance of this patent application in the U.S., Japan and China. The patent is currently pending in Canada. Repirinast is the Company’s lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51% with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction mouse model.
“This is our first patent issued by the EPO and marks another key milestone for the company,” said Christopher Moreau, CEO.
REVIVE TO INVESTIGATE BUCILLAMINE IN CANCER: Revive Therapeutics (RVVTF) announced Thursday that it has been contacted by a clinical researcher from a U.S. University Cancer Institute. The researcher aims to investigate Bucillamine’s potential as a cancer treatment, particularly for boosting anti-tumor effects in patients with advanced solid tumors. This evaluation of Bucillamine in solid tumors would be integrated into a broader study, supported by funding from the NIH and/or other government entities. This proposed research builds on the strategy of evaluating novel uses of Bucillamine in academic and government supporting studies, including the partnership with Defence R&D Canada – Suffield Research Centre, evaluating Bucillamine as a potential treatment for nerve agent exposure. Results from this study are expected shortly.
Michael Frank, CEO, commented, “We look forward to collaborating with a top U.S. cancer institute to investigate Bucillamine’s potential for solid tumors, confirming its anti-inflammatory and antioxidant effects, since inflammation and oxidative stress are recognized contributors to cancer initiation and growth.”
OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Cybin (CYBN), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), 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), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).
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