Ovid Therapeutics Inc. (NASDAQ: OVID) stock plunged 49.77% to 3.34 in the after-market session following the biotech corporation dedicated to developing therapies that change the lives of people with rare neurological disorders, officially revealed the findings of the Company’s Phase 3 NEPTUNE clinical trial of OV101 (gaboxadol) for the treatment of Angelman syndrome.
The primary endpoint of the NEPTUNE analysis has not been met. OV101 patients reported a 0.7-point increase in CGI-I-AS over baseline, while placebo also showed a 0.8-point improvement in CGI-I-AS (p=NS). Secondary endpoints continue to be tested, while the initial findings may not indicate any distinction between OV101 and placebo.
NEPTUNE is an observational, double-blind, placebo-controlled, Phase 3 trial that enrolled and examined 97 patients diagnosed with Angelman Syndrome, 4-12 years of age, and seven patients diagnosed with Angelman Syndrome, 2-3 years of age, for protection and pharmacokinetic assessment only. The study was intended to determine OV101 (oral, once-daily) effects versus placebo therapy over 12 weeks. The only primary outcome was a boost in the average performance on the Therapeutic Global Impression-Improvement-Angelman Syndrome (CGI-I-AS) scale. Secondary endpoints included sleep, connectivity, motor control, socialization, everyday life skills, and behavioral realms.
OV101 was well-tolerated, with no major safety risks reported. The Organization will continue to sell research medications to patients participating in the open-label expansion trial (ELARA) before the further review of the NEPTUNE study has been carried out. The Company expects results from the ELARA analysis to be released in the first quarter of 2021.