CAMBRIDGE, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, today announced that it has received comments from the U.S. Food and Drug Administration (FDA) on the full clinical hold of its Investigational New Drug (IND) submission for PRAX-114 for the treatment of major depressive disorder (MDD).
The IND for PRAX-114 was placed on clinical hold by the FDA pending the resolution of certain non-clinical pharmacology and toxicology matters. In its comment letter, the FDA proposed that the Company conduct further toxicological investigation of the effect of PRAX-114 and its metabolites on fertility, reproduction, and embryofetal development to support the planned trial. The Company believes that the results of its ongoing standard fertility and reproductive studies, expected to be completed in the first quarter of 2021, together with the available toxicology package will satisfy the FDA request. The FDA also requested updates to the Investigator’s Brochure and to the requirements for contraception in the protocol.
The Company now expects to initiate the randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in MDD in the first half of 2021. The Company is in dialogue with the FDA and intends to explore potential options to accelerate the initiation of the Phase 2/3 clinical trial.