Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of MDMA Transdermal Patch

Revive Therapeutics, a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a research collaboration agreement with PharmaTher Holdings to evaluate the delivery of 3,4-Methylenedioxy​methamphetamine (“MDMA”) using PharmaTher’s novel microneedle patch (“MN-Patch”) delivery technology.

Michael Frank, CEO of Revive, commented, “We are excited about the potential of the MDMA microneedle patch, which will complement our psilocybin programs for mental health and abuse disorders. We look forward to advancing the MDMA patch program that could fill the gaps that we believe could offer an advantage to oral MDMA treatments.”

PharmaTher has completed a non-clinical research study evaluating the delivery of its MDMA MN-Patch. Research results from this study will be available in early Q2-2023 and will be used to support a potential human clinical study. Based on the results, Revive and PharmaTher will finalize a product and clinical development plan to initiate regulatory discussions for future clinical studies in various indications where MDMA may have promise, including depression, anxiety, abuse disorders (i.e. eating, alcohol and drug use), and post-traumatic stress disorder.

Currently, the nonprofit Multidisciplinary Association for Psychedelic Studies (“MAPS”), through its wholly-owned subsidiary, MAPS Public Benefit Corporation (“MAPS PBC”), has completed two confirmatory Phase 3 trials of MDMA-assisted therapy for PTSD to potentially support its new drug application to be filed with the U.S. Food and Drug Administration (“FDA”) in 1H-2023. The FDA decision for potential approval of MDMA-assisted therapy for PTSD is expected in 2024.

In addition to developing bucillamine for infectious diseases and rare disorders, Revive is building a specialty psychedelics program, which includes psilocybin and MDMA to treat mental health and abuse disorders.

The Company’s psilocybin programs include:

• evaluating psilocybin in a Phase 1/2 clinical study for methamphetamine use disorder via a research collaboration with the University of Wisconsin-Madison.
• developing a novel psilocybin oral thin film strip through a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films.
• developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University.

This collaboration will allow Revive to evaluate the results of PharmaTher’s MDMA MN-Patch for indications that do not overlap with the Company’s psilocybin initiatives. The Company believes that the MDMA MN-Patch may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles which could overcome the potential obstacles of oral dosing.