MAPS PBC is entering into a collaboration that aims to bring its novel therapy for PTSD closer to regulatory evaluation.
MAPS Public Benefit Corporation (MAPS PBC) has selected MMS Holdings (MMS) as its contract research organization for the development of a New Drug Application (NDA) for MDMA-assisted therapy for posttraumatic stress disorder (PTSD).
This announcement follows MAPS PBC’s May milestone of finishing enrolment for its confirmatory phase 3 trial, MAPP2.
MAPP1, the first of two Phase 3 trials conducted by MAPS PBC to evaluate investigational MDMA-assisted therapy for treatment of PTSD, showed that 88 per cent of participants experienced a mean 44.7 per cent (24.4 point) reduction in PTSD symptoms two months after the last experimental session, with no serious safety signals emerging.
In addition to being granted Breakthrough Therapy designation, MDMA-assisted therapy has the potential to become the first-in-class FDA-approved psychedelic-assisted therapy.
MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project management support.
Chief scientific officer at MMS, Uma Sharma Ph.D., commented: “Part of our mission at MMS is using our decades of experience to bring life-changing therapies to positively improve patient lives worldwide. While PTSD was identified decades ago, we remain woefully behind with therapeutic treatment options. This collaboration with MAPS PBC and their groundbreaking therapy may change the course of PTSD treatment and could greatly impact those with the disorder.”
MMS brings decades of experience developing new drug applications, averaging support for eight to 12 annually, and specialising in first-in-class and other challenging submissions with their creative approach. Since inception, MMS sponsors have not received a refusal to file or a complete response letter, giving MAPS PBC the confidence that a successful submission dossier will be submitted to the FDA.
Chief scientific officer at MAPS PBC, Berra Yazar-Klosinski, Ph.D., commented: “MAPS PBC is excited to work with a Contract Research Organization like MMS that has years of neuroscience and regulatory submission experience.
“Together, we can work towards gaining FDA approval and bringing this treatment to patients and families who may greatly benefit from it.”
[activecampaign form=52]
