Clearmind's CMND-100 Meets Primary Safety Endpoint
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a primary endpoint achievement, a grant program and analyst views.CLEARMIND'S CMND-100 MEETS PRIMARY ENDPOINT:Clearmind Medicineannounced Tuesday that CMND-100, the company's proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder hasResults from the third cohort of the trial indicated a high safety profile for CMND-100, even at the higher dosage administered to date. The data demonstrated that the drug candidate was well tolerated, with no serious adverse events reported in the third cohort and continued favorable overall tolerability, consistent with the safety outcomes observed in prior cohorts. The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Meeting the primary safety and tolerability endpoint in this dose-escalation stage, including at the higher dosage in the third cohort, supports continued advancement of CMND-100 as a potential novel, non-hallucinogenic treatment option for AUD.Additionally on Wednesday, Clearmind announced that its independent Data and Safety Monitoring Board has completed its review and issued a positive recommendation to continue the ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder. The positive DSMB recommendation follows the completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. As a result, the company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.COMPASS ANNOUNCES U.S. GRANT PROGRAM:Compass Pathwaysannounced Monday an invitation for U.S. based organizationsto deliver investigational COMP360 psilocybin treatment, if approved. Many high-quality training organizations already exist and have trained thousands of HCPs in core and psilocybin-specific psychedelic care. This grant program was established to support the development of high-quality training content, including a COMP360-specific module, with the aim of ensuring HCPs are well-prepared to care for patients receiving COMP360 following the expected commercial launch. Organizations who apply for these grants should have the capabilities to develop and deliver psychedelic treatment training content to ensure the highest standards of care delivery and consistent patient experience. Through the grant program, Compass expects to award up to three organizations grants to support the development of foundational psychedelic and COMP360-specific training. Applications will be accepted from April 14 through May 14."As we prepare for the potential commercial launch of COMP360 for treatment-resistant depression, our priority is ensuring that healthcare providers are trained, confident, and ready to deliver COMP360 treatment responsibly where eligible patients may receive care," said Dr. Steve Levine, Chief Patient Officer. "Through this grant program, we look forward to collaborating with credible and experienced training organizations to develop high quality content to ensure multidisciplinary teams of providers are ready to deliver psilocybin treatment at scale, if approved. This initiative represents an important step to making training for COMP360 broadly available and supporting operational readiness ahead of a U.S. launch."DEFINIUM PRICE TARGET RAISE:Canaccord raised the firm's price target on Definium Therapeuticstoon the shares. The firm believes the shares represent a significant opportunity heading into DT120 Phase 3 data for depression in late Q2. They believe shares of Definium could be up 50% or more on a solid Emerge result.Additionally, Piper Sandler initiated coverage of Definium with an Overweight rating and $49 price target. The firm said Definium's orally disintegrating tablet form of lysergide D-tartrate, DT120, represents a "best-in-class" opportunity in an emerging neuroplastogen space. Piper expects more differentiated antidepressant and anxiolytic options for populations that have been badly underserved by over a generation of therapeutic stagnation. It believes DT120's peak U.S. sales potential is well in excess of $3B, translating into a "compelling risk/reward profile" at current share levels.BRIGHT MINDS INITIATED WITH BUY:Jefferies initiated coverage of Bright MindswithThe firm said the company's oral BMB-101 is a potential best-in-class 5-HT2C agonist. BMB-101 has generated positive Phase II data in absence seizures and broad developmental and epileptic encephalopathy, two $1B+ epilepsy markets with minimal treatment options, the analyst said.HELUS PHARMA INITIATED WITH BUY:TD Cowen initiated coverage of Helus PharmawithThe firm believes the company's positive Phase 2 adjunct major depressive disorder data for HLP003 and precedent clinical data validating psilocybin-based therapies "de-risk" the company's Phase 3 program. The first Phase 3 two-dose HLP003 dataset is due in Q4, which could drive "major upside" in the shares, the analyst said. TD models a 2028 launch and peak U.S. sales of $1.3B.Meanwhile on Thursday, Helus Pharma announced the appointment of Ken Kramer as Senior Vice President, Medical Affairs. Most recently, he served as Vice President and Head of Medical Neuroscience at Bristol Myers Squibb."Strong medical leadership is vital to how we connect with and serve the scientific and clinical communities," said Michael Cola, CEO. "Dr. Kramer brings both deep experience and an execution mindset to help us scale medical capabilities and advance our pipeline. His leadership will be instrumental in translating strong science into meaningful engagement with patients, providers, and payors."NRX APPOINTS TYSON AS CCO:NRx Pharmaceuticalsannounced Monday the appointment of Glenn Tyson as theAs NRx looks forward to the anticipated approval of its Abbreviated New Drug Application for the preservative-free ketamine product, it looks to build its commercial capabilities and prepare for a successful launch. Most recently, Tyson has focused on the emerging sector of companies developing neuroplastic therapies for psychiatric conditions, including leadership level work with Transcend Therapeutics. As CCO, Tyson will be responsible for building world-class market-access, distribution, sales and marketing functions to support commercialization of this NDA, as well as future pipeline assets in psychiatry designed to address the tremendous unmet needs of people suffering with serious mental illnesses."We are excited for Glenn to join the NRx executive team. His passion for people suffering with serious mental illnesses, and his vast relevant experience in the industry successfully building and leading commercial functions gives us great confidence as we prepare for the anticipated launches of our portfolio of products," said Jonathan Javitt, CEO.Additionally on Thursday, NRx announced the incorporation of NRx Defense Systems, a Florida-based research and development subsidiary, charged with development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation under robotic-enabled neuro-navigation, using already developed technology. The company anticipates participating in future government and non-governmental research and development on a basis that is non-dilutive to current shareholders. NRx Defense Systems will be led by Dr. Dennis McBride, whose career spans the intersection of CNS disorders, neuroplastic therapy, and robotics. McBride will be supported by NRx's newly-appointed Chief Medical Innovation Officer, Professor Joshua Brown, who currently serves as Director of Transcranial Magnetic Stimulation Research at Harvard/McLean and is the Principal Investigator on projects related to TMS and neuroplastic therapy currently funded by the National Institutes of Health and DARPA. A key objective of the NRx Defense Systems initiative is to develop robotic and artificial intelligence-enabled solutions that can be forward-deployed within military organizations without relying on a new layer of skilled medical professionals. The prototype is being developed in partnership with Zeta Surgical. NRx and Zeta anticipate unveiling the prototype robotic-enabled TMS technology with neuroplastic therapy at the 14th Annual meeting of the Clinical TMS Society from June 4-6.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, AtaiBeckley, BetterLife, Enveric Biosciences, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.
