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Ovid Therapeutics (NASDAQ:OVID) has announced its financial results for Q3 2019 ended September 30. As quoted in the press release: “2020 is poised to be a transformational year for Ovid. We expect multiple clinical trial data readouts across our pipeline including topline results from our pivotal Phase 3 NEPTUNE trial in Angelman syndrome,” said Jeremy …
Ovid Therapeutics (NASDAQ:OVID) has announced its financial results for Q3 2019 ended September 30.
As quoted in the press release:
“2020 is poised to be a transformational year for Ovid. We expect multiple clinical trial data readouts across our pipeline including topline results from our pivotal Phase 3 NEPTUNE trial in Angelman syndrome,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “All of our development programs demonstrate strong momentum. This is highlighted most recently by the initial positive results from our ENDYMION study in rare epilepsies, robust enrollment trends in our randomized ELEKTRA study, as well as the commencement of patient enrollment in the pivotal Phase 3 NEPTUNE trial. We completed a public equity offering in October and now have the resources necessary to take us through these anticipated clinical data inflection points. We are excited by the upcoming events in our pipeline and believe they hold great promise for creating value for both patients and shareholders.”
Recent Progress and Upcoming Milestones
OV101 (gaboxadol) for Angelman Syndrome
- Commenced patient enrollment in the pivotal Phase 3 NEPTUNE trial.
○ Topline results from the trial are expected in mid-2020.OV101 (gaboxadol) for Fragile X Syndrome
- Results from the Phase 2 ROCKET trial are expected in early 2020.
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
- Reported positive initial data from the open-label extension ENDYMION trial from patients who previously completed Ovid’s 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE.
○ Overall, safety and tolerability observations with soticlestat in the ENDYMION study were consistent with the completed Phase 1b/2a clinical trial.
○ Longer-term data from ENDYMION out to 48 weeks suggest increased seizure reduction with prolonged treatment of soticlestat in this difficult-to-treat, adult patient population with various types of DEE.
○ Median seizure frequency reductions were 84% following 25-36 weeks (n=6) and 90% following 37-48 weeks (n=4) of treatment.
○ Longest seizure-free durations experienced by two different patients were 264 consecutive days and 150 consecutive days, respectively.- Initial data from the open-label Phase 2 ARCADE trial in individuals with Dup15q syndrome or CDKL5 Deficiency is expected in the first quarter of 2020.