Psychedelic: Clearmind expands trial for Alcohol Use Disorder

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a trial expansion, a study approval and preclinical results.

CLEARMIND EXPANDS AUD CLINICAL TRIAL: Clearmind Medicine (CMND) announced Tuesday the expansion of its Phase I/IIa clinical trial for CMND-100, its proprietary MEAI-based oral treatment candidate for Alcohol Use Disorder, with the activation of an additional site at Johns Hopkins University School of Medicine and the enrollment of the first participant at this clinical site. The trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy indicators assessing its potential to reduce alcohol cravings and consumption. This expansion comes shortly after the company announced the enrollment of its first participant at the Yale School of Medicine. The Phase I/IIa clinical trial is a multinational, multicenter, single- and multiple-dose study that aims to establish the safety and optimal dosing of CMND-100.

“Each new clinical site we activate and each new participant we enroll brings us one step closer to validating CMND-100’s potential to redefine the treatment landscape for AUD,” said Dr. Adi Zuloff-Shani, CEO. “This expansion reflects both the scientific community’s interest in our approach and our commitment to accelerating progress for patients in need of better solutions.”

CYBIN RECEIVES MHRA APPROVAL FOR EMBRACE STUDY: Cybin (CYBN) announced Thursday that it has received approval from the UK Medical and Healthcare Products Regulatory Agency to commence EMBRACE, the second pivotal study in PARADIGM, the company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The company previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for CYB003 for the adjunctive treatment of Major Depressive Disorder. EMBRACE will enroll 330 patients suffering from moderate to severe MDD who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 mg, CYB003 8 mg, or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose.

“MHRA approval to initiate the EMBRACE component of our PARADIGM program in the UK marks an important step forward as we advance our lead program, CYB003, through the regulatory process,” said Doug Drysdale, CEO. “The Agency’s decision serves as strong validation of both the quality of our data and the urgent need to develop new and effective therapeutics to treat depression. With expected enrollment of 330 participants suffering from moderate to severe MDD, the EMBRACE study aims to generate critical late-stage data that, ultimately, may lead to transforming the standard of care for patients in need.”

ENVERIC REPORTS EB-003 PRECLINICAL RESULTS: Enveric Biosciences (ENVB) announced Tuesday results in a preclinical, exposure-based therapeutic model for post-traumatic stress disorder. In fear conditioned mice, oral administration of EB-003 significantly decreased context-induced freezing behavior when measured one-hour post-dose indicating a positive therapeutic effect with extinction of contextual fear after a single dose. These results were in line with the therapeutic effects observed with MDMA, which was used as a positive control in this study. MDMA is a psychedelic controlled substance that has demonstrated clinical benefit in the treatment of PTSD in human trials, although it is not approved by the FDA. The pairing of electrical shock stimulus with a controlled environment generates context-based traumatic memories leading to freezing behaviors when the subject is re-exposed to the same environment. This well-established translational rodent model, performed by a third-party lab, is designed to induce a potent, trauma-related state of fear using a Pavlovian association paradigm.

“Only a few medications have been approved by the FDA for the treatment of PTSD, including the serotonin reuptake inhibitors paroxetine and sertraline,” said Joseph Tucker, CEO. “Only 20% to 30% of PTSD patients experience full remission with these drugs and it takes two to three weeks of SSRI administration before clinical and neuronal benefits become apparent. Clearly, there is enormous unmet need in PTSD, which has yet to be addressed with meaningful innovation. Research has implicated impaired hippocampal neuroplasticity as key underlying features of patients struggling with PTSD. We are very encouraged that a single dose of our lead neuroplastogen, EB-003, facilitated rapid fear extinction in mice.”

SILO PHARMA COMPLETES DOSING IN SPC-15 STUDY: Silo Pharma (SILO) announced Wednesday completion of dosing in a U.S. Food and Drug Administration-requested 7-day safety and toxicology large animal study of its lead asset SPC-15, and bioanalytical and safety/toxicology results for the study are expected within 60 days. Two remaining SPC-15 studies are currently in progress or being planned: an IND-enabling GLP-compliant toxicology and toxicokinetic animal study, and a device study of SPC-15’s formulation-specific microchip-based nasal spray system. Silo plans to seek the FDA’s 505(b)(2) regulatory pathway for approval of SPC-15.

“Our novel PTSD drug candidate SPC-15 has already shown strong safety and therapeutic delivery, and we are confident about the final data results from our preclinical discovery program,” said Eric Weisblum, CEO. “We remain on track to conclude our two remaining final preclinical studies and planning to submit an investigational new drug application for SPC-15.”

ANALYST SAYS COMPASS TRIAL DELIVERS REGULATORY WIN: H.C. Wainwright reiterated (CMPS) on Tuesday, telling investors in a research note that the Phase 3 COMP005 trial delivered a regulatory win for COMP360 and the Phase 3 COMP006 trial is positioned to build on that success. The ongoing COMP006 trial, which is exploring a fixed repeat dosing regimen, is on track for a 26-week data readout in 2H26 and is expected to provide insight into durability and re-dosing strategy with COMP360, the firm said.

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), Filament Health (FLHLF), GH Research (GHRS), 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) and Seelos Therapeutics (SEEL).