Ovid Therapeutics announces results for Phase 1 study of OV329

Ovid Therapeutics (OVID) announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic, PD, activity of OV329, a next generation GABA-aminotransferase, GABA-AT, inhibitor being developed for drug-resistant epilepsies. In the Phase 1 study, OV329 demonstrated: Highly significant GABAergic inhibition as measured via multiple TMS biomarkers. OV329 at a 5 mg dose increased inhibition by 53% as measured on the APB muscle by the LICI 150 milliseconds from baseline to post-treatment in the 5 mg multiple ascending dose cohort. In contrast, placebo showed a nonsignificant reduced inhibition of 24.9% change. OV329 similarly increased inhibition by 44.3% as measured on the FDI muscle compared to a nonsignificant change 59.5% in placebo. Measures of inhibition were comparable to or exceeded those published for therapeutic doses of VGB1. OV329’s inhibition exceeded that of therapeutic doses of VGB as measured by the LICI 150 ms. Increases in the CSP, an additional measure of inhibition, were observed. In the 5 mg cohort, OV329 prolongated the CSP in the FDI from 124.08 ms at baseline to 137.00 ms at Day 7 as compared to placebo which changed from 105.11 ms to 107.72. Increased GABA concentrations relative to placebo and participants’ pre-treated baseline. After 7 days of dosing OV329 at 5 mg, mean GABA levels increased in the medial parietal lobe by 7.13% compared to 0.24% in placebo (n=4) using MRS and fitting model. Although not statistically significant because of baseline variability, findings are consistent with OV329’s intended mechanism of action.