The early 1970s saw psychedelics and psilocybin products made illegal in the US in the war on drugs. Decades later, new research indicates the medical potential of psilocybin and psychedelics in the treatment of chronic pain and mental illness, which affect approximately 20.4% and 20.6% of the adult population respectively. As psychedelics gain more recognition, companies such as Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF), Seelos Therapeutics (NASDAQ:SEEL), Numinus Wellness Inc. (TSXV:NUMI) (OTC:LKYSF), Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED), and Mydecine Innovations Group Inc. (NEO:MYCO) (OTCMKTS:MYCOF) are engaging in research initiatives to develop psychedelic-assisted therapies for different mental illnesses and chronic pain conditions.
Fibromyalgia is a disease of the central nervous system that is estimated to affect as much as 2% to 8% of the population. It can result in widespread pain, fatigue, memory problems, sleep disturbances, and generally reduced quality of life. The current treatment for the condition includes antidepressants, painkillers, and NSAIDs, although these interventions are often unsuccessful, resulting in nearly 30% of patients turning to opioids for pain relief and less than 10% of patients adhering to approved treatments after one year.
In response to the unmet medical needs in fibromyalgia patients, Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) seeks to provide psilocybin-based therapies for fibromyalgia. Tryp will be collaborating with the Chronic Pain & Fatigue Research Center in the Department of Anesthesiology at the University of Michigan Medical School, a leading center in chronic pain research. The upcoming Phase 2a trial is believed to be the world’s first Phase 2 trial utilizing psilocybin for a chronic pain indication.
The primary objective of the clinical trial is to evaluate the effectiveness of TRYP-8802 8802 (an oral formulation of synthetic psilocybin) and accompanying psychotherapy for the treatment of fibromyalgia. The clinical trial seeks to apply the neuroplasticity benefits of psilocybin to address the source of pain signals in fibromyalgia patients.
The results from the trial will be used in designing a larger Phase 2b clinical trial for fibromyalgia to advance the treatment toward approved use. Tryp Therapeutics intends to submit its IND application to the FDA for the Phase 2a clinical trial in Q3 2021.
“We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia,” said Jim Gilligan, Ph.D., President, and Chief Science Officer at Tryp Therapeutics. “The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients.”
Earlier in July, Tryp Therapeutics announced another partnership with the University of Michigan to evaluate its proprietary psilocybin-based formulation, TRP-8803, as part of its Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program. The series of studies is designed to expand the company’s intellectual property portfolio and to prepare TRP-8803 for use in Phase 2b clinical trials.
Companies Conduct Clinical Research into Psilocybin-based Therapies
Clinical stage biopharmaceutical company Seelos Therapeutics (NASDAQ:SEEL) announced that it dosed the first patient in its Part 2 of the registrational Proof of Concept study of SLS-002 for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. Seelos Therapeutics, which develops therapies for central nervous systems disorders and rare diseases aims to change the current standard of care for suicidal patients, which could potentially allow patients to be discharged sooner and treated as outpatients. According to Seelos’ Chairman and CEO, the company has gained invaluable information from Part 1 of the study that helped in the design and execution of Part 2. The company intends to continue its discussions with the FDA on the regulatory pathway for SLS-002 (intranasal racemic ketamine).
Numinus Wellness Inc. (TSXV:NUMI) is focused on providing innovative, safe, and evidence-based psychedelic-assisted therapies to promote health and wellness among people. The company recently announced the clearance of its MAPS-sponsored single-arm open-label safety and feasibility study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). According to the CEO of Numinus, the approval of the study could “potentially advance Canada toward a legal, regulated system for MDMA-assisted therapy.” After receiving the “No Objection” letter from Health Canada, Numinus is preparing the study by training staff, importing medication, and obtaining ethical approval. During the study, Numinus intends to collect data on the safety and efficacy of MDMA-assisted therapy to support making these therapies available to PTSD patients in Canada.
Meanwhile, clinical-stage biotech company MindMed (NASDAQ:MNMD) (NEO:MMED) is partnering with Datavant, Inc. where MindMed will use Datavant’s linking technology to connect its clinical trial data to external data from other clinical trials and real-world uses. With Datavant’s technology, MindMed hopes to prevent data fragmentation and facilitate a deeper understanding of real-world treatment, illnesses, and paths of care. MindMed seeks to gather and relate more data about patients’ access to, use, and experience with different treatment modalities over time. Through the linked data, MindMed hopes to enhance clinical trial planning, execution, and commercialization of its psychedelic-inspired therapies.
Mydecine Innovations Group Inc. (NEO:MYCO) (OTCMKTS:MYCOF) is another company seeking to develop psilocybin-assisted psychotherapy for veterans with PTSD. The company announced its plans to launch its Phase 2a clinical trial on psilocybin-assisted therapy for PTSD in veterans with the hope to achieve safer and accurate psychedelic-assisted psychotherapy results in a supervised setting. Mydecine is waiting for the final approval of its IND before launching the clinical trial, which is scheduled for late Q3 or early Q4 2021.
Psychedelic-assisted therapies are gaining recognition as a possible treatment for mental illnesses, and chronic pain, with companies such as Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) advancing their research into related therapies through upcoming human clinical trials.
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