Ovid Therapeutics Outlines 2019 Clinical and Business Priorities
-- OV101 in Angelman syndrome: Pivotal Phase 3 NEPTUNE trial expected to begin in second half 2019 --
-- OV101 in Fragile X syndrome: Phase 2 ROCKET clinical trial results in adolescents and young adults expected in second half 2019 --
-- OV935/TAK-935 in rare developmental and epileptic encephalopathies: Recent results from Phase 1b/2a trial in adults expected to bolster current clinical development program in children; enrollment in ARCADE trial in CDKL5 deficiency disorder and Duplication 15 syndrome expected to complete in second half 2019 --
“2018 was a year of exciting clinical achievement and disciplined corporate execution, as we made important steps forward in two rare disorders with significant unmet medical needs: Angelman syndrome and rare developmental epilepsies,” said
“In 2019, the anticipated start of our pivotal Phase 3 trial in Angelman syndrome, results from our Phase 2 ROCKET trial for OV101 in Fragile X syndrome, and the continued progress of our Phase 2 trials from our broad development program in DEE for OV935 each has the potential to redefine the way patients and families are living with these rare disorders.”
2018 Highlights and Anticipated 2019 Clinical and Regulatory Milestones
OV101 for Angelman Syndrome
A novel delta (δ)-selective GABAA receptor agonist entering Phase 3 clinical development.
Based on results announced in 2018 for the Phase 2 STARS clinical trial and discussion with the
In 2019, Ovid expects to achieve the following key milestones for its Angelman syndrome program:
- Enroll first patient in the ELARA trial, an open-label extension study, in the first quarter of 2019.
- Submit Phase 2 STARS clinical results for publication in a peer-reviewed medical journal.
- Finalize protocol and operational plans for Phase 3 NEPTUNE trial and submit to
FDAin the first half of 2019.
- Initiate enrollment for Phase 3 NEPTUNE trial in the second half of 2019.
- Engage with
European Medicines Agency(EMA) on OV101 clinical development plans.
OV101 for Fragile X Syndrome
In 2019, Ovid expects to achieve the following key milestones for OV101’s Fragile X syndrome program:
- Complete enrollment in Phase 2 ROCKET trial; announce data in second half 2019.
- Complete enrollment in Phase 2 SKY ROCKET; announce data in second half 2019.
OV935 for Rare Developmental and Epileptic Encephalopathies (DEE)
A potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as a novel approach to treating epilepsy. OV935 is being developed in the context of a unique collaboration with
In a press release issued
Ovid expects to achieve the following key milestones in 2019 for the OV935 development program:
- Submit Phase 1b/2a clinical trial results for peer-review presentation at a scientific medical meeting in first half 2019.
- Engage with EMA on OV935 clinical development plans.
- Continue enrollment in ENDYMION open-label extension trial.
- Complete enrollment in the second half of 2019 in the Phase 2 ARCADE trial, an open-label trial evaluating patients 2 to 17 years of age diagnosed with CDKL5 deficiency disorder and Duplication 15q syndrome.
- Continue enrollment in Phase 2 ELEKTRA trial, a randomized, double-blind, placebo-controlled trial evaluating patients 2 to 17 years of age diagnosed with Dravet syndrome and Lennox-Gastaut syndrome.
- Continue to evaluate the potential for plasma 24HC to be a biomarker.
- Continue to evaluate ex-U.S. licensing opportunities and potential partnerships that could accelerate the development of OV101 in Angelman and Fragile X syndromes and other potentially broader areas and could also provide potential non-dilutive forms of capital.
For more information on Ovid, please visit http://www.ovidrx.com/.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding progress, timing, scope and results of clinical trials for Ovid’s product candidates, the reporting of clinical data regarding Ovid’s product candidates, the study of the role of 24-S-hydroxycholesterol (24HC) as a plasma-based biomarker, the publication of data in medical journals, the timing and outcome of future interactions with regulatory authorities, the approval or registration of Ovid’s product candidates by regulatory authorities, and the completion of any licensing or partnership agreements. You can identify forward-looking statements because they contain words such as “will,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the
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