Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has issued a progress update on its psilocybin pharmaceutical programs ahead of the first clinical study on psilocybin for methamphetamine use disorder.
The company is evaluating the psychedelic substance as a potential treatment for methamphetamine use disorder in conjunction with the University of Wisconsin-Madison. The study will be conducted at the university and provide proprietary information to support future US Food and Drug Administration (FDA) clinical studies.
“Revive is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders,” the Toronto-based company said in a statement.
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“We are embarking on our first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch, which will offer flexible therapeutic solutions of psilocybin for unmet medical needs," it added.
Revive also provided updates on several other psilocybin initiatives. The firm is evaluating psilocybin as a potential treatment for stroke, also with the University of Wisconsin-Madison. The proposed Phase I/II clinical study protocol to evaluate the safety and feasibility of psilocybin for stroke is expected to be submitted to the IRB in February.
In addition, Revive has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders. Research prototype development is underway to support IND-enabling studies with the expectation to conduct a clinical study in 4Q 2022, the company said.
As for its microneedle patch program, Revive noted that it has finalized the project plan and will initiate IND-enabling studies with the expectation to conduct a clinical study in 4Q 2022.
Revive is also developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University. The company expects to complete a research-grade batch of psilocybin for research in 2Q 2022 with the aim to conduct clinical studies in 2023.
Finally, Revive said it will kick off clinical research shortly on its novel psychedelic-assisted therapies, including its tannin-chitosan delivery system, in Antigua and Barbuda, where it is aiming to commercialize products this year in the country.
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