Clearmind Completes Second Cohort Enrollment for CMND-100 Trial
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on an enrollment completion, a CDMO selection and a listing transfer.CLEARMIND COMPLETES SECOND COHORT ENROLLMENT FOR CMND-100 TRIAL:Clearmind Medicineannounced Tuesday thein its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the company's proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. The cohort consists of six patients, who were recruited rapidly across three clinical sites: Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The enrollment follows the recent completion of the first cohort, which demonstrated encouraging top-line safety and efficacy data, including a favorable safety profile and preliminary signals of reduced cravings and withdrawal symptoms. The multinational Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Dosing for the second cohort is expected to commence shortly, with topline results anticipated in the coming months."We are thrilled with the accelerated pace of enrollment for our second cohort, which reflects the high level of interest from both patients and leading clinical sites in CMND-100's potential to transform AUD treatment," stated Adi Zuloff-Shani, CEO. "Building on the excellent results from the first cohort, we believe that this rapid progress positions us to generate additional valuable data, bringing us closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile."PHARMALA SELECTS CDMO FOR ALA-002 MANUFACTURING:PharmAla Biotechannounced Monday that its wholly-owned subsidiary, PharmAla Biotech Australia, hasto execute manufacture of its ALA-002 drug substance. ALA-002 is PharmAla's patented, novel, non-racemic MDMA formulation. PharmAla has publicly announced that it will be initiating Phase 2a/2b clinical research into the formulation exploring Social Anxiety Disorder in 2026."PharmAla Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA-002 drug product components," said Nick Kadysh, CEO. "This is an important and necessary step to us executing our ALA-002 Phase 2 clinical trial in 2026, and the first time since 2022 that PharmAla will be developing a wholly new Active Pharmaceutical Ingredient for human use."Additionally, PharmAla announced that it has completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Center for Psychedelic Healing at Mount Sinai. The material is scheduled to be used in clinical research.CYBIN TO TRANSFER LISTING TO NASDAQ:Cybinannounced Thursday that it will voluntarilyfrom the NYSE American. The company expects that its common shares will cease trading on the NYSE American at market close on January 4, 2026 and commence trading on Nasdaq at market open on January 5, 2026. Concurrent with the commencement of trading on Nasdaq, the company will no longer trade under the ticker symbol "CYBN" and instead will trade under the ticker symbol "HELP". The company will continue to be listed on the Cboe Canada and will also trade under the new "HELP" ticker symbol commencing on January 5, 2026."We are pleased to join the community of global pharmaceutical companies listed on Nasdaq and thank the NYSE American for supporting the company over the last four years since our initial listing," said Eric So, interim CEO. "The transfer to Nasdaq marks the next step in the evolution of Cybin into a global pharmaceutical company."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, Atai Beckley, BetterLife, Bright Minds, Compass Pathways, Enveric Biosciences, Filament Health, GH Research, Incannex, Mind Medicine, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.
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- Clinical Trial Progress: Clearmind Medicine Inc. has successfully completed treatment and follow-up for 18 participants in its Phase 1/2a clinical trial for CMND-100, a non-hallucinogenic drug for Alcohol Use Disorder (AUD), reflecting strong momentum across its multinational study sites.
- Patient Recruitment Expansion: The successful treatment of four additional participants at the Tel Aviv clinical site further expands enrollment, demonstrating the operational strength of its Israeli centers while providing more data to support the drug's potential efficacy.
- Urgent Treatment Need: AUD is a chronic condition with limited existing treatments, making the development of CMND-100 significant as it may offer new therapeutic options for patients struggling with long-term recovery.
- Safety and Tolerability: CEO Dr. Adi Zuloff-Shani noted that the steady progress underscores the favorable safety and tolerability profile of CMND-100, bringing the company closer to delivering an innovative therapy for AUD and advancing its pipeline of non-hallucinogenic therapeutics.
- Clinical Trial Progress: Clearmind Medicine has successfully completed treatment and follow-up for 18 participants in its FDA-approved Phase I/IIa clinical trial, indicating a favorable safety and tolerability profile for its non-hallucinogenic drug CMND-100 aimed at treating Alcohol Use Disorder, thereby enhancing the company's innovative capabilities in the biotech sector.
- Israeli Center Expansion: The successful treatment of four additional participants at the Tel Aviv clinical center demonstrates the operational strength of this site, increasing Clearmind's engagement in the multicenter study and potentially accelerating the recruitment of subsequent patients.
- Multicenter Research Advantage: Conducted at leading institutions such as Yale University, Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, the trial ensures scientific rigor and enhances Clearmind's reputation within the industry, positioning it favorably for future collaborations.
- Intellectual Property Strategy: Clearmind's portfolio includes 19 patent families and 31 granted patents, with plans to seek additional patents as warranted, reflecting its long-term strategic positioning and competitive edge in the drug development landscape.
- Patent Application Progress: Clearmind Medicine has filed a patent application in India for next-generation psychedelic-based compounds aimed at treating mental health disorders and addiction, further expanding its global intellectual property portfolio.
- Innovative Drug Development: The compounds protected by this patent are designed to overcome the limitations of classical psychedelics, offering potentially safer, more effective, and scalable treatment options to address underserved mental health needs.
- Intellectual Property Strategy: Clearmind currently holds 19 patent families, including 31 granted patents, and plans to seek additional patents as warranted to enhance its market competitiveness and technological barriers.
- Market Potential: By entering into an exclusive global licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, Clearmind's innovative drug development in the mental health space is poised to support its future commercialization efforts, addressing the growing market demand.
- Patent for Innovative Therapy: Clearmind Medicine Inc. has announced an international patent application for a novel therapy combining MEAI and Palmitoylethanolamide, aimed at treating obesity and metabolic dysfunction-associated steatotic liver disease, potentially benefiting over 890 million obese adults worldwide.
- Significant Market Potential: The global weight loss drugs market was valued at approximately $37 billion in 2025 and is projected to reach $226 billion by 2035, indicating a strong demand for innovative alternatives, positioning Clearmind's new therapy to capture a share of this rapidly growing market.
- Strengthened Partnerships: The development of this therapy is bolstered by collaboration with NeuroThera Labs Inc., integrating Clearmind's MEAI platform with PEA to offer a safer and more cost-effective treatment option compared to GLP-1 agonists, enhancing the company's competitive edge in the biotech sector.
- Strategic Development Focus: CEO Dr. Adi Zuloff-Shani emphasized the company's commitment to developing innovative therapies to address underserved metabolic and neurological health issues, further solidifying its leadership position in the biotechnology industry.
- Clinical Trial Progress: Clearmind's CMND-100 has received a recommendation to continue its FDA-approved Phase I/IIa clinical trial from the independent Data and Safety Monitoring Board (DSMB), based on positive safety data from the second cohort, indicating a favorable safety and tolerability profile.
- Dose Increase: The second cohort received a dose that was double that of the first cohort, with no serious adverse events reported, further reinforcing CMND-100's safety and supporting its rapid advancement to the third cohort with an 80 mg dose, which is expected to accelerate treatment progress.
- Multicenter Study: The clinical trial is being conducted at leading sites, including Johns Hopkins University and Tel Aviv Sourasky Medical Center, with the second cohort completing treatment shortly after DSMB clearance, demonstrating confidence in CMND-100 as a potential innovative therapy for Alcohol Use Disorder (AUD).
- Intellectual Property Strategy: Clearmind currently holds 19 patent families and 31 granted patents, with plans to seek additional patents as warranted, enhancing its competitive position in the psychedelic drug market and driving future commercialization efforts.
- Therapeutic Progress: Clearmind Medicine's MEAI drug has made significant strides in obesity treatment, with preclinical studies indicating a potential 20% weight reduction while prioritizing muscle preservation, showcasing its promise as a next-generation neuroplastogen that could transform obesity management.
- Innovative Mechanism: MEAI targets the brain's monoaminergic system to modulate reward and addiction pathways, addressing psychological roots of obesity such as compulsive eating and emotional overeating, potentially offering a more holistic treatment approach compared to traditional GLP-1 drugs, thereby enhancing long-term patient adherence.
- Market Potential: According to Goldman Sachs, the obesity market is projected to exceed $100 billion in the coming years, positioning Clearmind to potentially lead the next era of weight loss therapeutics if MEAI fulfills its promise, addressing the urgent global demand for effective weight loss solutions.
- Strategic Partnerships and Patents: Clearmind has recently filed new patent applications targeting obesity and metabolic disorders, collaborated with Polyrizon to develop an intranasal formulation for improved delivery, and is advancing its FDA-approved Phase I/IIa trial for alcohol use disorder, demonstrating its ongoing commitment to innovative drug development.









