The global need for effective mental health treatment has led to the growing push for the legalization of psychedelic therapies, pushing the market into the mainstream. Last week, Michigan Senator Jeff Irwin introduced legislation that would decriminalize the use of mescaline and psilocybin. If passed, Senate Bill 631 would allow the possession, cultivation, and delivery of mescaline and psilocybin. In addition, the bill will allow practitioners to charge for counseling and spiritual guidance if they use an entheogenic plant or fungus. This legislation coupled with the growing body of research that proves the effectiveness of psychedelics against mental health conditions is among the reasons pushing the psychedelics market towards $69 billion by 2026 . As this happens, companies like Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF), Cybin Inc. (NEO:CYBN), Compass Pathways (NASDAQ:CMPS), PhamaTher (OTCQB:PHRRF) (CSE:PHRM), and Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED) are pushing R&D efforts to develop and test psychedelic therapies for different health conditions.
Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to evaluate its clinical candidate TRP-8802 in a Phase 2a clinical study for the treatment of eating disorders.
The pharmaceutical company, which develops psilocybin-based compounds for conditions with unmet medical needs, submitted the application weeks after the company completed psychotherapy training for the upcoming Phase 2a trial. The Phase 2a trial, which is being conducted at the University of Florida with Jennifer Miller, M.D, will evaluate Tryp’s oral formulation of synthetic psilocybin in combination with psychotherapy.
Tryp’s IND application has details on the safety of the drug product, the study protocol, informed consent information for patients, and additional information. The Phase 2a study expects to enroll ten patients with a variety of overeating disorders including binge eating disorder, hypothalamic obesity, and Prader-Willi syndrome. The company expects that the psilocybin oral formulation will increase neuroplasticity and therefore, help create healthy neural patterns of hunger and eating.
Tryp Therapeutics anticipates beginning the study in Q4 2021 following a favorable review from the FDA. Commenting on the IND submission, Jennifer Miller, M.D. said, “The submission of this IND represents hundreds of hours of preparation, design, and coordination as we pursue a leading-edge treatment of psilocybin with psychotherapy.”
Greg McKee, Chairman and CEO of Tryp Therapeutics also commented, “This IND submission marks the most important milestone the company has achieved to date and will be critical to identifying patient responses to the active ingredient, consistent with that of our proprietary drug candidate, TRP-8803, that will be used in Phase 2b trials and beyond.”
The company also intends to make additional IND submissions in the coming months for clinical trials in chronic pain and eating disorders with at least two Phase 2a clinical trials starting before the end of the year.
For more information on Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF), click here.
These Companies are Advancing Psychedelics Research for Conditions with Unmet Needs
Cybin Inc. (NEO:CYBN) recently filed applications for two additional international patents which, once approved, will give the company patent coverage in 153 countries for each of the patents. The patent applications, according to the company, will strengthen the CYB005 program, which is focused on developing therapies for resistant psychiatric disorders and provide a basis for future research. In addition, the patent applications secure the company’s rights to apply for national patents in treaty member jurisdictions and key markets, thus supporting Cybin’s strategic objectives.
Meanwhile, mental health company Compass Pathways (NASDAQ:CMPS), has acquired an IP portfolio that includes patent applications for various psychedelics and empathogenic substances. The IP portfolio was developed in collaboration with Dr. Matthias Grill PhD., CEO and Founder MiKHAL GmbH who has been involved in psychedelic chemistry research for over 15 years. Grill will be working with Compass on an exclusive research project to develop new product candidates. The agreement to work with Dr. Matthias and MiKHAL GmbH will strengthen Compass’ IP and development portfolio with new compounds that the company will move to clinical development towards helping patients with unmet mental healthcare needs.
Clinical stage psychedelics biotech company PhamaTher (OTCQB:PHRRF) (CSE:PHRM) has received the Orphan Drug Designation from the U.S. Food and Drug Administration for ketamine in the treatment of Amytrophic Lateral Sclerosis (ALS). This designation allows the company to proceed to its Phase 2 clinical study on patients suffering from ALS and validates the effectiveness of ketamine as an effective therapy for neurologic disorders. The designation is a major milestone for the company, which is targeting a therapy that increases the survival rate for approximately 50,000 people in the US who are diagnosed with the life-threatening condition.
Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED), a biotech company involved in the development of psychedelic-based therapies, and BioXcel, a biopharmaceutical company published BioXcel’s international patent for detecting and preventing the early onset of agitation in patients susceptible to highly agitated behavior due to acute and chronic neurological illness. The patent covers a method for caregivers to detect signs of impending agitation, thus preparing them to treat the patient before these symptoms develop into agitation. Through this method, caregivers can reduce the need for intensive intervention by de-escalating the agitated behavior earlier.
R&D initiatives will be important not only in developing therapies for unmet medical needs but in providing science-backed data that will inform future legislation. Companies like Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) are making it possible for psychedelics to become recognized as therapies that can be used in the treatment of many conditions.
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