Revive Therapeutics has announced that it is working on its first Phase I/II clinical study to evaluate oral psilocybin in the treatment of methamphetamine use disorder.
Specialty life sciences company Revive Therapeutics will be advancing the study as well as the development of its proprietary oral psilocybin thin film strip product.
The company has confirmed it is currently evaluating the use of oral psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison.
Under an investigator-initiated IND, led by Dr Christopher Nicholas and Dr Paul Hutson, the Phase I/II clinical study received both FDA and Institutional Review Board approval and is being conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.
The clinical data generated from the study will provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support future pivotal FDA clinical studies for Revive Therapeutics’ proposed oral psilocybin thin film strip product. The company will have exclusive access to key intellectual property from the study to support development, regulatory and commercial initiatives.
COO of Psilocin Pharma, a division of Revive, Derrick Welsh, commented: “We continue to focus on building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders.
“We intend to advance the development of our oral psilocybin thin film strip product for these indications. In parallel, we are working on our first clinical study evaluating oral psilocybin in the treatment of methamphetamine use disorder to validate its use in substance abuse indications.
“The clinical data from this study will be used to support late-stage clinical trials with our oral psilocybin thin film strip product.”
For its film strip, Revive Therapeutics has stated it has initiated its product development programme under a feasibility agreement with LTS Lohmann Therapie-Systeme AG.
The proprietary oral psilocybin thin film strip product will be developed for mental illness, substance abuse and neurological disorders, and prototypes of the product have been developed and are currently being optimised for use in upcoming IND-enabling studies. A first-in-human clinical study is expected in 2023.
