Psychedelic: MindMed announces dosing in Phase 3 Emerge study

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on dosing, data on a ketamine analog and a notice of allowance.

MINDMED REPORTS DOSING IN PHASE 3 EMERGE STUDY: Mind Medicine (MNMD) announced Tuesday that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of Major Depressive Disorder. Emerge will evaluate the efficacy and safety of MM120 ODT 100 µg versus placebo and is expected to enroll approximately 140 participants in the United States. Emerge is the third Phase 3 study of MM120 ODT, with the Voyage and Panorama studies in Generalized Anxiety Disorder already underway. The Phase 3 development program for MM120 ODT in MDD is anticipated to include two pivotal clinical trials. The first, the 52-week Emerge study, will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity. In Part A, participants will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. The primary endpoint of Emerge is the change from baseline in MADRS score at week 6 between MM120 ODT 100 µg and placebo. The design and timing of a second MDD trial will be informed by the progress from Emerge and additional regulatory discussions.

“In our Phase 2b study, MADRS score improvements after a single MM120 100 µg dose were clinically and statistically significant compared to placebo, providing meaningful benefits to participants. Having dosed the first participant in the Phase 3 Emerge study, we are excited for the therapeutic potential that MM120 ODT shows for the 21 million people in the U.S. affected by MDD,” said Daniel Karlin, CMO. “By running our MDD and GAD Phase 3 studies concurrently, we can leverage the shared symptomatology between these conditions to more effectively match participants to the appropriate study based on their clinical presentation.”

MIRA REPORTS KETAMIR-2 RESULTS IN DIABETIC NEUROPATHY: MIRA Pharmaceuticals (MIRA) announced Wednesday data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy. In the study, Type 2 diabetes was induced in rats using a high-fat diet combined with a low dose of Streptozotocin . This resulted in hyperglycemia and neuropathic symptoms, including hyperalgesia and allodynia, mimicking human diabetic pathology. By week 8, most diabetic rats exhibited sensory hypersensitivity. Treatment with Ketamir-2 led to a significant reduction in neuropathic pain symptoms, with some animals returning completely to pre-diabetic baseline sensitivity. Unlike traditional ketamine, Ketamir-2 does not induce dissociative or psychedelic effects and is not a substrate for P-glycoprotein, allowing for more efficient penetration across the blood-brain barrier. MIRA has already begun dosing and recruitment in its Phase I clinical trial at Hadassah Medical Center in Jerusalem. The study is progressing smoothly and on schedule. The randomized, double-blind, placebo-controlled trial is assessing safety, tolerability, and pharmacokinetics in healthy volunteers. Completion is expected in Q4, with a Phase IIa study in diabetic neuropathy patients planned to follow. MIRA anticipates initiating its Phase IIa clinical trial in diabetic neuropathy by the end of 2025, with first human efficacy data expected in the first half of 2026. In parallel, development of a topical slow-release formulation of Ketamir-2 continues, aimed at providing localized pain relief with minimized systemic exposure.

“Millions of patients with diabetic neuropathy are left with limited, often ineffective treatment options,” said Erez Aminov, CEO. “With Ketamir-2, we’re aiming to offer a non-opioid alternative that’s not only safer but potentially more effective. We’re currently advancing our Phase I study and plan to initiate a Phase IIa trial in diabetic neuropathy patients by year-end. Given that the FDA has designated neuropathic pain as a high-priority area for Fast Track and Breakthrough Therapy pathways, we believe Ketamir-2 is uniquely positioned to meet this urgent need and unlock significant clinical and commercial value.”

CLEARMIND RECEIVES NOTICE OF ALLOWANCE FOR PATENT: On Thursday, Clearmind Medicine (CMND) announced that the United States Patent Office has issued a Notice of Allowance for a patent relating to its MEAI treatment for binge behavior.  This new U.S. patent provides additional intellectual property protection for the company’s MEAI- based treatment in this indication and further strengthens Clearmind’s intellectual property portfolio. 

Dr. Adi Zuloff-Shani, CEO, commented: “This Notice of Allowance further strengthens our unique position in the space and growing intellectual property portfolio and reinforces the potential of our robust MEAI program. Securing foundational patent protection is a vital step in supporting our future success and in driving the development of next-generation psychedelic-derived therapeutics with the potential to deliver transformative outcomes for patients.”

PSYENCE GROUP ANNOUNCES SHARE CONSOLIDATION: Psyence Group (PSYGF) announced Thursday that the company will be consolidating all of its issued and outstanding share capital on the basis of every fifteen old common shares into one new common share, effective April 23. As a result of the consolidation, the issued and outstanding common shares will be reduced to approximately 9,387,695 on the effective date. The company believes that consolidation will position the company with greater flexibility for the development of its business and the growth of the company.

QUANTUM BIOPHARMA WINS RECONSIDERATION MOTION: On Monday, Quantum BioPharma (QNTM) announced that the reconsideration motion by Dr. Raza Bokhari at the Court of Appeal for Ontario was dismissed entirely in favor of Quantum BioPharma.  Bokhari, current CEO of Medicus Pharma (MDCX), was CEO of FSD Pharma, now Quantum BioPharma, in 2019 and was terminated for cause in July 2021. As previously disclosed, Arbitrator Cunningham dismissed Bokhari’s claim that the company had wrongfully dismissed him, awarding FSD Pharma approximately C$2.81M in costs of the arbitration plus interest. Also, $175,000 in costs were awarded by Justice Conway in respect of the set aside application, and $5,000 in costs were awarded by the Court of Appeal totaling $180,000 in respect of Bokhari’s failed motion for leave to appeal. Bokhari filed a re-consideration motion with the Court of Appeal for Ontario which is now dismissed entirely and $180,000 in awards is now due. Quantum BioPharma filed and served a Petition to Confirm Arbitration Award in the United States District Court for the Eastern District of Pennsylvania to formally begin the process to collect the monies awarded from Bokhari. An order was granted and judgment was entered in favor of FSD Pharma, now Quantum BioPharma, and against respondent Bokhari on June 27.  Bokhari also appealed this order and judgment and was granted stay and provided the supersedeas bond for $2,882,441.48 through the date of the issuance of the mandate by the United States Court of Appeals for the Third Circuit. Judgment by the United States Court of Appeals is pending. 

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Cybin (CYBN), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).