Ovid Therapeutics Announces Phase 1 Study Results for OV350
Ovid Therapeutics announced results from its Phase 1 study of OV350, the first-ever Potassium-Chloride Cotransporter 2, KCC2, direct activator known to be dosed in humans. The study met its primary objectives to evaluate safety, tolerability and pharmacokinetics. Results from this intravenous program support the advancement of the Company's portfolio of oral KCC2 direct activators into the clinic. Key findings include: At 50 mg and 100 mg doses of OV350, exposure levels achieved expected pharmacologically active concentrations reinforcing the potential for further clinical development of KCC2 direct activators, including OV4071, which performs with twenty-fold greater potency than OV350 in pharmacodynamic models. The most frequent treatment-emergent adverse event associated with OV350 was headache. Nausea and vomiting occurred in a subset of participants who experienced headache. These AEs coincided with the timing of food intake and are believed to be caused by secondary off-target pharmacology unique to OV350. There were no treatment-emergent SAEs associated with OV350 and stopping criteria were not met in the study. The pharmacokinetics were as predicted for all doses. qEEG findings supportive of central activity and spectral power relevant for the expected pharmacologic impact of KCC2 modulation were observed. These effects were contemporaneous with the expected exposure of OV350 in the brain.
