Study completion marks an important next step in the Company's Europe program
SAN JOSE, Calif., April 24, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced the completion of a European Phase 2 study (MP18), an open-label, multicenter feasibility study of investigational midomafetamine (MDMA) capsules used in combination with psychological intervention ("MDMA-assisted therapy") for adults with post-traumatic stress disorder ("PTSD"). Having completed the pivotal clinical Phase 3 studies in the United States, the new drug application ("NDA") for Lykos' investigational midomafetamine capsules is currently under review by the U.S. Food and Drug Administration ("FDA").
"Given the substantial need for new treatment options for individuals with mental health conditions in Europe, the completion of this Phase 2 study is an important step to helping address unmet needs outside the United States," said Amy Emerson, chief executive officer at Lykos Therapeutics. "By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe. We are exploring different avenues to bring MDMA-assisted therapy to market outside the United States."
The study included twenty-one participants treated in sites in the Netherlands, United Kingdom, Czech Republic, Germany, and Norway. The study included an optional fMRI sub-study assessing changes in brain activity in subjects with PTSD.
"Successful completion of this Phase 2 study in Europe is an important step to build on the body of evidence evaluating the efficacy and safety of MDMA-assisted therapy in the United States where this novel therapeutic approach now is under FDA review," said Eric Vermetten, professor of psychiatry at Leiden University Medical Center and lead investigator of the study. "There is an urgent need for new and effective evidence-based treatments for PTSD in Europe where the reported PTSD prevalence is up to 6.7%."1
On February 9, 2024, the FDA accepted the company's NDA for midomafetamine (MDMA) capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with PTSD. The FDA granted the application Priority Review and has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024. The FDA grants Priority Review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.2 If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications.
Lykos Therapeutics (Formerly MAPS PBC)
At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare. We're applying our decades in evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are relentlessly exploring and reimagining novel approaches to address unmet needs in the mental healthcare space, with an initial focus on PTSD. As a PBC, we are focused on delivering positive impact on our people, communities and society. To learn more visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.
1 Burri A, Maercker A. Differences in prevalence rates of PTSD in various European countries explained by war exposure, other trauma and cultural value orientation. BMC Res Notes. 2014;7:407. doi: 10.1186/1756-0500-7-407
2 FDA Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed January 2024.
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