News & Events zu Optimi Health Corp (OPTH)OPTHOptimi Health Corp

Optimi Completes Psychedelic Production and Starts Clinical Trial

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a production completion, a strategic investment and patent publications.OPTIMI COMPLETES PSILOCYBIN PRODUCTION:Optimi Healthannounced Wednesday the completion and quality release of amanufactured end to end at the company's cGMP facility in Princeton, British Columbia, under a Health Canada Drug Establishment Licence. The batch will supply the recently announced Phase 2 clinical trial of psilocybin-assisted therapy in the treatment of major depressive disorder and commercial customers in Australia. This Health Canada-authorized trial is a multisite, open-label study of up to 200 participants, each receiving a single supervised dose. Patient dosing is expected to be completed by the end of 2027. Data from the trial are intended to assess the safety and efficacy of psychedelic-assisted therapy in the hope of building the necessary evidentiary base to support registration in Canada and other jurisdictions. The same batch will also supply the company's Australian customer base of licensed clinics, where 5mg psilocybin capsules are prescribed to patients with treatment-resistant depression under the Therapeutic Goods Administration's Authorised Prescriber Scheme, with reimbursement from public and private payers."Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression," said Dane Stevens, CEO. "We are excited to be collecting our own clinical data on the same product in our Health Canada-approved Phase 2 clinical trial for major depressive disorder. One drug, two indications with significant unmet need, one batch serving both. Because we manufacture, encapsulate and release-test within our own licensed facility, the trial product and the commercial product are the same formulation from the same batch, and the Chemistry, Manufacturing and Controls file that supports registration is already ours."Optimi also announced Tuesday the appointment of Michael Blough as Chief Clinical Development Officer. In this newly created position, he will oversee Optimi's clinical development strategy and related operations. Blough is a medical researcher with more than 20 years of experience directing research programs spanning bench science, pre-clinical studies, and clinical trials.PSYENCE BIOMED ANNOUNCES IBOGAINE INVESTMENT:Psyence Biomedicalannounced Wednesday that it has agreed to make atogether with a value-matched share exchange between the two companies. The transactions are intended to support the scientific, manufacturing and development capabilities required for Psyence BioMed's planned U.S. ibogaine program. TIRC, registered and headquartered in Texas, has been established to provide a dedicated corporate structure through which the company can coordinate its planned U.S. regulatory, clinical and development activities involving pharmaceutical-grade ibogaine. The company is currently evaluating the feasibility and design of a potential ibogaine clinical trial in Texas. Any clinical program would be subject to protocol development, regulatory review and authorization, institutional approvals, funding, site selection and other customary requirements."Access to pharmaceutical-grade ibogaine is fundamental to the U.S. program we are planning," said Jody Aufrichtig, CEO. "Our investment in PsyLabs, together with the share exchange, is intended to align Psyence BioMed more closely with the manufacturing and supply capabilities we believe a regulated clinical program will require, while TIRC provides the dedicated U.S. structure through which we intend to advance that program. Our objective is to advance this program responsibly, supported by rigorous clinical research and pharmaceutical-grade manufacturing."CLEARMIND REPORTS PUBLICATION OF THREE PATENT APPLICATIONS:Clearmind Medicineannounced Wednesday thecovering novel proprietary combinations of lysergic acid diethylamide, ketamine and ibogaine with N-acylethanolamines, such as palmitoylethanolamide. The covered applications address potential therapeutic uses across a range of indications, including mental health disorders, such as depression, post-traumatic stress disorder pain and substance use disorders. The publications expand the intellectual property generated through Clearmind's ongoing collaboration with NeuroThera Labs, a subsidiary of SciSparc, under which NeuroThera's PEA technology is integrated into Clearmind's psychedelic-derived therapeutic programs."The publication of these patents come at a significant time as clinical and regulatory interest in LSD, ketamine and ibogaine continues to receive growing recognition and support for their therapeutic potential. Clearmind believes its combination approach may offer the potential for an effective and safer treatment paradigm, aiming to achieve therapeutic benefits at lower doses while preserving efficacy. By reducing the dose required to achieve the intended pharmacological effect, this approach may support improved tolerability while maintaining therapeutic potential," said Adi Zuloff‑Shani, CEO.FILAMENT DELIVERS PEX010 TO BHRI:Rhelion Life Sciencesannounced Monday that Bruyere Health Research Institute in Ottawa hasa patented, standardized, GMP manufactured botanical psilocybin drug candidate, from Filament for the Phase 3 trial titled "Psilocybin Microdose for Psychological and Existential Distress in Palliative Care: A Multi-Site Phase 3 Double-Blind, Placebo-Controlled, Parallel-Arm Clinical Trial". The trial will compare microdose psilocybin with placebo in people with advanced illness who are experiencing psychological distress, such as depression, anxiety and loss of meaning. It plans to enroll 120 participants from inpatient, outpatient and community palliative care settings across seven sites in Canada. Participants take small daily doses that do not cause hallucinations and do not require accompanying psychotherapy, an approach designed to be practical for patients near the end of life. Bruyère Health Research Institute is the sponsor of the trial. The Phase 3 trial builds on the Phase I/II PSYCHED-PAL study, sponsored by The Ottawa Hospital Research Institute, which also used PEX010. Results published in Palliative Medicine in 2026 found that microdose psilocybin was safe, feasible and potentially effective for psychological distress in a palliative setting, with participants reporting improvements in depression, anxiety, demoralization and well-being and no serious adverse effects.The company also announced Tuesday that the Canadian Intellectual Property Office has issued a new patent to Filament, titled "Psychoactive Alkaloid Extraction and Composition with Controlled Dephosphorylation."BARCLAYS SAYS HELUS SELLOFF 'A BUYING OPPORTUNITY":Barclays said it viewed the selloff Friday in shares of Helus Pharmaas a buying opportunity. The firm initiated the stock on Friday morning withBarclays said its initiation was not intended to serve as a preview of the Phase 3 APPROACH study of HLP003 in adjunctive treatment of MDD in isolation. The 7-8 point range discussed in the initiation "was neither our base-case expectation nor a required outcome for our $35 price target," the analyst said. The firm said it represented an illustrative extrapolation of the Phase 2 HLP003 result using attenuation observed in selected Phase 2-to-Phase 3 precedents.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds Biosciences, Compass Pathways, Definium Therapeutics, Eli Lilly, Enveric Biosciences, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Revive Therapeutics, Sibannacand Silo Pharma.

Optimi Health Plans to Initiate Phase 2 Trial in 2027

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study initiation plans, a Breakthrough Therapy designation and Phase 3 study data.OPTIMI TO INITIATE PHASE 2 TRIAL OF PSILOCYBIN-ASSISTED THERAPY:Optimi Healthannounced Thursday plansfor individuals with major depressive disorder. The trial is planned to be initiated in 1H27, with dosing expected to be complete by the end of 2027. The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind."A 200-subject Phase 2 trial in major depressive disorder is the largest clinical commitment Optimi has made to date. We will supply our own naturally derived psilocybin, manufactured at our GMP facility, and we will have exclusive ownership of the trial results," said Dane Stevens, CEO "As we broaden our strategy to include clinical drug development, this Phase 2 trial is an initial step toward potential registration. Few companies in this sector are commercial today while also advancing their own clinical development. In Canada, we already hold a Drug Establishment Licence and supply psilocybin through Health Canada's Special Access Program. This trial builds directly on that foundation, and we can comfortably fund it with current cash on hand."DEFINIUM RECEIVES BREAKTHROUGH THERAPY DESIGNATION:Definium Therapeuticsannounced Tuesday that the U.S. Food and Drug Administration has grantedThe designation was supported by the significant unmet medical need in MDD and results from the company's Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in MADRS total score at Week 6, with durable efficacy through Week 12. This milestone marks the second Breakthrough Therapy designation from the FDA for the DT120 development program, following its initial designation for the potential treatment of Generalized Anxiety Disorder."Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our Phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders," said Rob Barrow, CEO. "This recognition of DT120's promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications. Our focus remains on developing innovative therapies that have the potential to expand treatment options and improve outcomes for the millions of people who continue to seek meaningful relief."COMPASS REPORTS DATA FROM PHASE 3 COMP005 TRIAL:Compass Pathwaysannounced Wednesday the toplinea synthetic, proprietary formulation of psilocybin, for treatment-resistant depression which further support COMP360's differentiated profile and potential for long lasting benefit. In the open-label Part C data, notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at Week 52 and extended out to one year for participants who were randomized to the 25 mg arm and received an additional dose in Part C. For participants in the Placebo arm who received their first dose of COMP360 25 mg in Part C, these findings further reinforce that a single dose of 25 mg has the potential to produce rapid onset, meaningful effect and durability. For all participants in Part C who received a 25 mg dose, strong response and remission rates were observed with 40%-45% responders and approximately 30% remitters across all timepoints in the six weeks post the Part C dose. The COMP360 safety profile in Part C is consistent with Parts A and B and continues to show a generally well-tolerated and safe profile with no new safety findings."COMP360 has now demonstrated rapid onset, substantial magnitude of effect and sustained durability through one year with just a few doses. This emerging clinical profile is unmatched in TRD and puts COMP360 in a league of its own," said Kabir Nath, CEO. "We are excited for what this means for TRD patients and for those who care for them and the potential to move beyond treatments that require daily or frequent administration. As we continue to advance COMP360 for patients, our rolling NDA submission and review are well underway, with final NDA submission expected in the fourth quarter and launch expected in the first half of next year, subject to FDA approval. With a robust clinical package, and growing patient and provider anticipation for COMP360 as a much-needed treatment for TRD, Compass is well-positioned and ready to deliver."Additionally on Thursday, Compass announced U.S. grant program recipients to create training programs for healthcare providers that will be involved in the delivery of psychedelic treatments, such as COMP360 psilocybin. These programs are intended to address both the need for foundational training in psychedelics, as well as ensuring HCPs are well-prepared to care for patients receiving treatment with COMP360 following its expected commercial launch, if approved. The recipients will remain independent training and education providers, retaining ownership and control of their training programs, content, faculty selection, and educational design, with Compass providing the grant program funding and recognizing them as grant awardees. In all, five organizations were awarded the grant, expanded from the originally three recipients due to the overall quality of applicants: CME Outfitters, Emory University, Fluence International, Integrative Psychiatry Institute and Strata Mental Health Solutions.CLEARMIND RECEIVES YALE IRB APPROVAL:Clearmind Medicineannounced Tuesday that thefor Parts B and C of its Phase I/II clinical trial evaluating CMND‑100. This approval advances the multicenter study, titled "A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND‑100 in Healthy Volunteers and Subjects with Alcohol Use Disorder" and directly enables the company to accelerate enrollment at Yale School of Medicine's Department of Psychiatry. The Yale site now joins other centers already approved and actively recruiting patients for the trial, including Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. The trial at the Yale site is led by Anahita Bassir Nia, MD, a specialist in psychiatry and addiction medicine.Adi Zuloff-Shani, CEO, commented, "Yale IRB approval to proceed with Parts B and C is an important milestone for our CMND-100 clinical program. This clearance allows us to immediately expand and accelerate patient recruitment at another world‑class site, alongside Johns Hopkins and Israeli medical centers, as we continue evaluating our proprietary non-hallucinogenic, MEAI-based candidate for individuals with AUD."Additionally on Friday, Clearmind announced that it has entered into a definitive agreement to acquire a 51% stake in Charging Robotics, which develops dedicated intelligent wireless charging systems designed specifically for automated parking facilities, autonomous mobile platforms and robotaxi operations. Under the terms of the agreement, Clearmind will acquire the majority stake of Charging Robotics for an aggregate purchase price of $2.5M. In addition, in connection with and as a condition to the closing of the acquisition, the company shall extend a loan to Charging Robotics in the principal amount of $1.5M. The loan shall bear interest at a rate of 4% per annum. The closing of the acquisition is expected to occur during the week of September 7 subject to the satisfaction of certain closing conditions.FILAMENT COMPLETES DELIVERY OF PEX010 TO AUSTRALIA:Rhelion Life Sciencesannounced Tuesday that its wholly owned subsidiary, Filament Health, hasits patented, standardized, GMP manufactured botanical psilocybin drug candidate, from Canada to Australia in support of an investigator initiated clinical trial. The trial, known as PSI-PHY, investigates psilocybin-assisted physiotherapy in adults with refractory motor functional neurological disorder. It is sponsored by The University of Melbourne, conducted at Austin Health, a public tertiary teaching hospital in Melbourne, and funded by the Medical Research Future Fund of the Australian Government Department of Health and Aged Care. Filament supplies PEX010 as the investigational drug product."For a decade this field has been framed as a mental health story, but newer research is starting to show the potential of natural psychedelics to help patients go beyond that." said Todd Shapiro, CEO of Rhelion. "If a natural psychedelic can help the brain relearn how to move, we are talking about neurology, rehabilitation, and potentially even anti-aging, not only psychiatry. Functional neurological disorder is one of the most common conditions a neurologist sees, and there is no approved pharmacological treatment for it. That is the kind of gap this company exists to help close."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include AtaiBeckley, Grey Matters Health, BetterLife, Bright Minds Biosciences, Enveric Biosciences, GH Research, Helus Pharma, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.

Optimi Health Announces Phase 2 Clinical Trial for Psilocybin Therapy

Optimi Health announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder. The trial is planned to be initiated in the first half of 2027, with dosing expected to be complete by the end of 2027. The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Asberg Depression Rating Scale total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind.