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Ovid Therapeutics Plans to Move into the Phase 3 Trial Based on End-of-Phase 2 Meeting for OV101
Dec. 06, 2018 08:47AM PST
Pharmaceutical InvestingOvid Therapeutics (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced plans to move ahead with a single pivotal Phase 3 trial of OV101 in pediatric patients with Angelman syndrome based on its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA). …
Ovid Therapeutics (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced plans to move ahead with a single pivotal Phase 3 trial of OV101 in pediatric patients with Angelman syndrome based on its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA).
As quoted in the press release:
CGI-I will be used as a single primary endpoint, mainly due to the rare nature of Angelman syndrome, the lack of treatment options, the nonexistence of assessment instruments specific to Angelman syndrome, the heterogeneity of the disorder, and the lack of sensitivity or appropriateness of other validated measures. Based on feedback from the FDA, Ovid will develop a framework for study investigators to ensure uniform use of the validated CGI-I scale by focusing on specific symptoms that are relevant and important to patients with Angelman syndrome and their caregivers.
Ovid expects to begin enrollment of the NEPTUNE trial in the second half of 2019, pending FDA concurrence on the study protocol and supporting framework and materials. Updates and further details of this trial, including secondary endpoints, will be provided upon trial initiation.
“It is important to acknowledge that while this meeting was a milestone for Ovid, and provides a clear path forward, it is an even more momentous one for the Angelman syndrome community,” said Jeremy Levin, DPhil, MB, BChir, chairman and chief executive officer of Ovid Therapeutics. “From the relationships we have formed within the community, to the completion of the first industry-sponsored trial in Angelman syndrome, we are very encouraged by the clinical progress we’ve made. With the thoughtful assistance and clear direction from the FDA, we now move forward to a pivotal trial that we hope will result in the first approved medicine for individuals living with this disorder.”