Psychedelic: atai reports dosing of first patient in Phase 2 VLS-01 trial

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a dosing initiation, a development expansion and a distribution agreement.

ATAI DOSES FIRST PATIENT IN PHASE 2 VLS-01 TRIAL: atai Life Sciences (ATAI) announced Tuesday that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai’s proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine applied to the buccal surface, in people suffering from treatment-resistant depression.

“Dosing the first patient in the Phase 2 Elumina trial of VLS-01 marks a significant milestone in our commitment to transforming the treatment landscape for mental health disorders,” stated Kevin Craig, CEO. “Millions worldwide struggle with treatment-resistant depression, often left with few or no viable options. With VLS-01, we see the potential to offer rapid, robust, and durable antidepressant effects that could provide meaningful relief where existing treatments fall short. This trial brings us one step closer to delivering a new and innovative solution to those people who need it most.”

Elumina is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of repeated doses of VLS-01. The trial consists of two treatment periods. In the first treatment period, approximately 142 patients will be randomized 1:1 to receive a 120mg dose of VLS-01 or placebo on Day 1, followed by a second dose of the same intervention at Week 2. The primary endpoint is the change from Baseline in Montgomery-Asberg Depression Rating Scale total score at Week 4. The last double-blind assessment visit will be at Week 14. The first treatment period will provide 12 weeks of blinded durability data following two doses of VLS-01 administered in a placebo-controlled fashion. Topline results from the first treatment period are anticipated in 1Q26.

MIRA EXPANDS KETAMIR-2 DEVELOPMENT WITH TOPICAL: On Thursday, MIRA Pharmaceuticals (MIRA) announced the formulation of Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain. This expands the company’s pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain, offering a novel, targeted approach for localized pain relief. The topical treatment of Ketamir-2 is designed for slow release, delivering targeted pain relief directly at the application site while minimizing systemic exposure and side effects.

“The development of both an oral and topical formulation of Ketamir-2 significantly expands our pipeline and enhances the value proposition of MIRA,” stated Erez Aminov, CEO . “By advancing two distinct formulations, we are positioning Ketamir-2 to address multiple pain conditions and broaden its potential applications. This strategic approach strengthens our presence in the pain management space and underscores our commitment to delivering innovative solutions while creating value for our shareholders.”

PHARMALA SIGNS DISTRIBUTOR IN THE NETHERLANDS: PharmAla Biotech Holdings (MDXXF) announced Monday that it has signed a distribution agreement with Duchefa Farma of Haarlem, Netherlands, to act as exclusive distribution agent for its LaNeo MDMA in the Netherlands market. The distribution agreement includes an annual purchase minimum, as well as restrictions on re-export and price controls. It also includes an escalator provision which would significantly increase the minimum purchase amounts in the 24 months following regulatory changes which allow for use of MDMA in the healthcare system. Duchefa will also act as Importer of Record as well as providing Qualified Person Release of PharmAla’s products.

“We are confident that this deal will open significant new opportunities for both Duchefa and PharmAla. This is the first new market we have officially opened since entering Australia in late 2023,” said Nick Kadysh, CEO. “In looking for a partner we can rely on, we were pleased to see that Duchefa has not only an incredible presence in the Netherlands, but exceptional relationships with partners from the Galenos Group across Europe. We are excited to fulfill the demand for clinical trial materials in the Netherlands, and to assist in pushing the Government of the Netherlands towards greater acceptance of MDMA-Assisted Therapy for the treatment of PTSD.”

CLEARMIND ANNOUNCES PATENT PUBLICATION: On Monday, Clearmind Medicine (CMND) announced the publication of a patent by the Korean Intellectual Property Office. The patent covers the company’s combination therapy of MEAI and N-Acylethanolamines for the treatment of cocaine addiction. The patent is based on preclinical trial results led by Professor Gal Yadid and his team at the Gonda Multidisciplinary Brain Research Center at Bar-Ilan University in Israel. These studies build upon earlier experiments in which animals treated with MEAI exhibited a significant reduction in cocaine-induced cravings. Further research was conducted in rats to assess whether MEAI’s effects on drug-seeking behavior extended to natural rewards, given that reward-based reinforcement is a fundamental survival mechanism across species. The study produced positive results, demonstrating that while MEAI reduced cocaine-seeking behavior, it did not impair the rats’ response to natural rewards such as sucrose. This finding suggests that MEAI’s impact on drug cravings is not tied to the general reward system but is specifically targeted at drug-related compulsions.

ANALYST STARTS PSYCHEDELIC FIRMS WITH BUYS: Guggenheim initiated coverage of Cybin (CYBN) on Wednesday with a Buy rating and $35 price target. The firm’s investment thesis is based on CYB003’s robust and durable antidepressant efficacy in Phase 2 major depressive disorder trials and its potential to replicate those data and deliver best-in-class data in Phase 3, the analyst said. The firm believes upside optionality remains, and with multiple key data readouts expected across the space in the next 6-12 months, it thinks now is the time for investors to start paying attention.

Guggenheim initiated coverage of GH Research (GHRS) with a Buy rating and $32 price target. The firm’s thesis on GH is based around the belief that rapid-acting psychedelics like 5-MeO-DMT have the potential to transform the treatment resistant depression treatment landscape, the analyst said. The firm added that, with pivotal milestones in the sector coming over the next 6-12 months and an update on the clinical hold anticipated this year, it believes GH is well-positioned for long-term upside.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex Healthcare (IXHL), Mind Medicine (MNMD), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).