In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a site initiation, a notice of allowance and a supply partnership.
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CLEARMIND COMPLETES INITIATION FOR CMND-100 TRIAL: Clearmind Medicine (CMND) announced Wednesday the completion of site initiation at Tel Aviv Sourasky Medical Center for its Phase I/IIa clinical trial evaluating CMND-100, a proprietary oral drug candidate for Alcohol Use Disorder. The Phase I/IIa trial, already underway at sites including Yale School of Medicine and Johns Hopkins University in the United States and TASMC and Hadassah-University Medical Center in Israel, is a multinational, multi-center study assessing the safety, tolerability, and pharmacokinetic profile of CMND-100. It also explores early efficacy signals, such as reduced alcohol cravings and consumption, in patients with AUD. The inclusion of TASMC as a clinical site, where the trial is led by Prof. David Zeltser, Director of the Emergency Medicine Department at TASMC, strengthens Clearmind’s clinical network and accelerates patient enrollment.
“We are thrilled to complete the initiation of Tel Aviv Sourasky Medical Center, a world-class institution, in our Phase I/IIa trial for CMND-100,” said Adi Zuloff-Shani, CEO. “This milestone brings us closer to potentially delivering an innovative, non-hallucinogenic treatment for AUD, addressing a critical unmet need for millions worldwide. We believe that our collaboration with leading centers like TASMC, Hadassah, Yale, and Johns Hopkins underscores the scientific community’s confidence in our approach.”
ENVERIC RECEIVES NOTICE OF ALLOWANCE FOR U.S. PATENT: Enveric Biosciences (ENVB) announced Wednesday a second Notice of Allowance from the United States Patent and Trademark Office for novel compounds within its EVM401 Series, expanding its intellectual property assets in the treatment of mental health disorders. The allowed patent application, titled “Substituted N-Propylamine Fused Heterocyclic Mescaline Derivatives,” covers a unique series of methylone-inspired compounds, which are structurally differentiated benzodioxole derivatives engineered as non-hallucinogenic modulators of neurotransmitters relevant for neuropsychiatric disorders.
“With this second patent allowance for the EVM401 Series, Enveric continues to strengthen its position as a first-in-class developer of neuroplastogenic small-molecule therapeutics,” said Joseph Tucker, CEO. “These patent-protected molecules are designed to capture the desirable neuroplasticity-promoting effects of methylone, while offering novel chemical structures that enable both strong IP protection and a potential path to repeat-dose outpatient care.”
FILAMENT HEALTH PARTNERS WITH UCL: Filament Health (FLHLF) announced Thursday that it has partnered with University College London to supply its botanical psilocybin drug candidate, PEX010, for two phase 2 research trials. The Medicines and Healthcare Products Regulatory Agency-approved trials will explore the effects of PEX010 on brain function, perception, and psychological wellbeing. The first of the two trials is a randomized controlled study evaluating the impact of the Digital Intervention for Psychedelic Preparation, a novel 21-day self-guided program designed to enhance therapeutic outcomes of psychedelic experiences. Participants are randomly assigned to one of two structured preparatory pathways: a meditation-based intervention or a music-based control condition, both delivered through the same digital platform. Following the 21-day program, all participants undergo a supervised 25 mg psilocybin session at UCL. The study aims to assess how different preparatory strategies influence the quality of psychedelic experience, levels of psychological readiness, and changes in mental wellbeing. The second trial, Amplifying Experimentally Induced Hallucinations With “Micro” Doses of Psilocybin, will explore how low doses of psilocybin affect the perception of geometric hallucinations and pareidolia, which is the tendency to see meaningful patterns in ambiguous stimuli. Building on models of excitatory visual cortex dynamics, the study will assess how low dose psilocybin-induced neural excitation interacts with external sensory input to shape hallucinatory experiences under controlled conditions.
“Understanding how preparation style and dose affect the psychedelic experience is vital for advancing safe, effective psychedelic therapies,” said Benjamin Lightburn, CEO. “We are proud to support these pioneering studies at one of the world’s preeminent research institutions.”
GHRS PROVIDES UPDATE ON FDA ENGAGEMENT: GH Research (GHRS) provided updates on its business and key upcoming milestones on Wednesday. The company said, “We have recently announced that we submitted a complete response to the previously announced clinical hold on our Investigational New Drug Application for GH001 with the U.S. Food and Drug Administration. We have now received a response from the FDA with only one hold topic remaining. The FDA requested that we either provide additional data or further justification related to the previously announced respiratory tract histology findings in rats. We strongly believe, based on scientific evidence, that the respiratory tract histology findings are rat specific. There are no additional requests related to dog toxicology. There are no device related issues remaining. Engagement with FDA on IND complete response is ongoing. We are actively working to address the remaining issue.”
The company previously reported on the initial results from the phase 2b clinical trial of GH001 in treatment-resistant depression, which included part of the open-label extension phase. On Wednesday, GH Research reported on the full dataset. The company said, “The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Åsberg Depression Rating Scale total score on Day 8. The full analysis of the OLE confirms a 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapeutic intervention. GH001 delivered consistent MADRS reduction with re-treatments as needed. 57.5% of patients achieved remission at day 8 and 90% of those were also in remission at month 6. Safety analysis confirmed that 100% of patients from the double-blind part continued in the OLE and there were no treatment related serious adverse events across the full 6-month duration of the trial. No treatment-emergent events of suicidal intent or suicidal behaviour occurred throughout the 6-month duration of the trial and lower rates of suicidal ideation were observed during the study in comparison to baseline. The psychoactive experience had a median duration of 11 minutes across the DB and OLE parts of the trial. Across the DB and OLE, patients were deemed discharge ready by 1 hour from dose administration at 99% of treatment visits. A majority of patients needed 1-2 doses of GH001 suggesting a 2-hour visit or less in a commercial setting.”
The company also noted the previously announced completion of a Phase 1, dose-ranging clinical pharmacology trial of GH002, a proprietary intravenous mebufotenin HBr product candidate, in healthy volunteers. The company said, “Top-line results demonstrate that GH002 was well-tolerated with no severe or serious adverse events and produced ultra-rapid psychoactive effects. The pharmacokinetic profile of GH002 was equivalent to that of GH001. We expect to submit an IND with the FDA for GH002 in Q4.”
OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Cybin (CYBN), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), MindMed (MNMD), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), 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) and Silo Pharma (SILO).
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Read More on CMND:
- Clearmind Medicine completes initiation at TASMC for Phase I/IIa trial
- Psychedelic: Clearmind expands trial for Alcohol Use Disorder
- Psychedelic: atai Life Sciences, Beckley Psytech report BPL-003 study results
- Clearmind Medicine announces IRB approval for Phase 1/2a trial for AUD
- Clearmind Medicine announces first participant ever dosed with CMND-100