Psychedelic: Bright Minds reports preclinical BMB-201 results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on preclinical data, a CEO change and a publication of study results.

BRIGHT MINDS REPORTS PRECLINICAL BMB-201 RESULTS: Bright Minds Biosciences (DRUG) announced Thursday preclinical results for its investigational compound BMB‑201, in a validated isosorbide dinitrate rat model of vascular headache. BMB-201 produced statistically significant reductions in facial mechanical allodynia across both male and female cohorts at 1 and 2 hours post-dose, compared to vehicle, and demonstrated greater effect sizes than sumatriptan at multiple timepoints. Key Results include robust efficacy versus vehicle at 1 and 2 hours in both sexes; Benchmark comparison: BMB‑201 showed greater effect sizes than sumatriptan at multiple timepoints and doses. These effect sizes reflect statistically significant improvements versus vehicle; Consistent activity across sexes and aligned with a nitric‑oxide trigger paradigm.

“BMB‑201 delivered strong and reproducible activity in a stringent vascular headache model, with efficacy signals that exceeded sumatriptan at multiple timepoints. This further validates the use of 5-HT2 agonists in pain management,” said Jan Torleif Pedersen, CSO.

CYBIN CEO STEPS DOWN: Cybin (CYBN) announced Tuesday that Doug Drysdale stepped down as the company’s CEO. The company’s co-founder and president, Eric So, has been appointed as interim CEO by the Board of Directors. The Board of Directors has established a committee to conduct a search for a new CEO.

“Cybin was founded with a singular mission: to transform the treatment paradigm for mental health. With a solid foundation of clinical progress, regulatory recognition, and strong partnerships, we remain well-positioned to drive our programs forward,” said So. “I am committed to ensuring continuity during this transition and to maintaining our focus on creating long-term value for both patients and shareholders. I want to thank Mr. Drysdale for his contributions. As Interim CEO, I look forward to executing on our strategy, advancing our clinical pipeline to successful approval of CYB003 and CYB004, and working closely with our partners as we move toward delivering innovative new therapies for patients in need.”

COMPASS ANNOUNCES PUBLICATION OF PHASE 2 COMP360 RESULTS: Compass Pathways (CMPS) announced Tuesday the publication of results from an open-label Phase 2 study evaluating the safety and tolerability of a single-dose of 25 mg of investigational COMP360 synthetic psilocybin treatment in 22 patients with post-traumatic stress disorder. The Phase 2 study findings, previously disclosed in May 2024, show that COMP360 was well tolerated and indicated both rapid and durable improvement in symptoms from baseline observed out to 12 weeks following a single administration. The international Phase 2 study was conducted across three sites in the U.K. and the U.S. There were no treatment-emergent serious adverse events. The most common treatment-emergent adverse events included headache, nausea, crying, fatigue, and visual hallucinations. Improvement in mean CAPS-5 total score from a baseline of 47.5 was observed. From a mean SDS total score of 22.7 at baseline, there was a 11.7 point reduction at week 4 and a 14.4 point reduction at week 12. Response, as defined by patients experiencing a ≥ 15-point reduction from baseline on CAPS-5 total score, was 81.8% at week 4 and 77.3% at week 12. Remission, as defined by CAPS-5 total score of ≤ 20, was 63.6% at week 4 and 54.5% at week 12.

“Affecting approximately 13 million people in the U.S., and with only two approved treatments in the past two decades, post-traumatic stress disorder represents an area of profound unmet need with limited innovation to date,” said Guy Goodwin, CMO. “We are proud to see the results from this Phase 2 study published in the Journal of Psychopharmacology. Based on the highly encouraging results, we are finalizing late-stage clinical trial designs and look forward to evaluating the full potential of COMP360 for the treatment of PTSD.”

SILO SECURES AUSTRALIAN PATENT: Silo Pharma (SILO) announced Wednesday that IP Australia has granted patent number 2020271839 to Silo’s research and licensing partner Columbia University for the invention titled “Prophylactic efficacy of serotonin 4 receptor agonists against stress” exclusively licensed to Silo by Columbia University. The patent reinforces protection for Silo’s lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder, originally developed by Columbia University.

“This patent further strengthens our global IP portfolio for SPC-15, protecting its novel approach to preventing stress-induced disorders and enhancing stress resilience,” said Silo CEO Eric Weisblum. “The claims further strengthen and support our plans for clinical trial development of SPC-15 as an innovative therapeutic for PTSD.”

PHARMALA INCORPORATES AUSTRALIAN ENTITY: PharmAla Biotech Holdings (MDXXF) announced Wednesday that it has incorporated PharmAla Biotech Australia, a wholly-owned Australian subsidiary, for the purposes of conducting research and development activities in Australia. PharmAla Australia will receive a full and perpetual license to the company’s ALA-002 asset and all associated patents, and will be positioned to execute both manufacturing development and clinical research in Australia.

“As many know, Australia continues to be a thriving market for biotech development. We believe that our familiarity with the market – our relationships and our experience – will drive significant synergies,” said VRO Nick Kadysh.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL).