Ovid Therapeutics Initiates Pivotal Phase 3 Clinical Trial in Angelman Syndrome; Multiple Data Readouts Across Rare Neurologi...
June 27 2019 - 8:00AM
Ovid Therapeutics Inc. (NASDAQ: OVID), today announced that
following a Type C Meeting with the U.S. Food and Drug
Administration (FDA), it has initiated the pivotal Phase 3 NEPTUNE
trial with OV101, a novel delta (δ)-selective GABAA receptor
agonist, in Angelman syndrome. Ovid plans to enroll the first
patients in NEPTUNE during the third quarter of 2019 and
anticipates topline data from the trial to be available by
mid-2020. The results of the trial, if positive, are intended to
support a New Drug Application for OV101 for the treatment of
Angelman syndrome. Members of Ovid’s senior management team, along
with external clinician experts, will review the Phase 3 NEPTUNE
trial design as well as provide additional pipeline program
highlights at today’s R&D day to be held from 12:00 p.m. to
3:00 p.m. EDT in New York City.
“Following productive discussions with the FDA, we have
initiated our pivotal Phase 3 NEPTUNE clinical trial in patients
with Angelman syndrome, which provides a clear path to
registration,” said Jeremy Levin, DPhil, MB, BChir, Chairman and
Chief Executive Officer of Ovid Therapeutics. “We will use the
CGI-I scale as used in the Phase 2 STARS trial as the sole primary
endpoint in our Phase 3 NEPTUNE trial. We have renamed the scale
CGI-I-AS to reflect the fact that relevant anchors and training
materials are specific to Angelman syndrome. The use of CGI-I-AS as
a sole primary endpoint is important. As was demonstrated in the
Phase 2 STARS trial, the CGI-I scale is designed to detect change
from baseline in each individual in a disorder with substantial
clinical heterogeneity.”
Dr. Levin continued, “Beyond Angelman syndrome, we continue to
execute across our pipeline and are looking forward to multiple
expected data readouts over the coming quarters, including from the
Phase 2 ROCKET trial with OV101 in Fragile X syndrome, the ENDYMION
trial with OV935 (soticlestat) in rare developmental and epileptic
encephalopathies, as well as the Phase 2 ARCADE trial with OV935 in
Dup15q syndrome or CDKL5 Deficiency Disorder.”
Key Program Updates and Highlights
OV101 for Angelman Syndrome
• Following an End-of-Phase 2 Meeting with the FDA held in 2018
and a subsequent FDA Type C Meeting held in 2019, Ovid has
initiated the pivotal Phase 3 NEPTUNE trial, which includes the
following elements:
- 12-week, two-arm, randomized, double-blind, placebo-controlled
trial;
- Once-daily dose of OV101 or placebo;
- Approximately 60 pediatric patients ages 4 to 12 years
diagnosed with Angelman syndrome;
- The sole primary endpoint for the Phase 3 NEPTUNE trial will be
the Angelman syndrome-specific CGI-I-AS scale. The CGI-I scale is
the same as that used in the Phase 2 STARS trial. Ovid refined
CGI-I anchors and clinician training materials specific to the core
symptoms of Angelman syndrome, renaming the endpoint CGI-I-AS;
- The trial includes secondary endpoints for sleep,
communication, motor skills, socialization, daily living skills and
behavior domains;
- A limited number of children ages 2-3 years will also be
enrolled to study pharmacokinetics (PK) and
safety/tolerability.
• Ovid plans to enroll the first patients in the Phase 3 NEPTUNE
trial in the third quarter of 2019, with topline results from the
trial expected by mid-2020.
• The open-label extension ELARA trial for individuals with
Angelman syndrome who previously completed a clinical trial with
OV101 continues to enroll patients.
• Ovid has also received agreement from German regulatory
authorities (BfArM) regarding the design of the Phase 3 NEPTUNE
trial and the use of CGI-I-AS as a sole primary outcome
measure.
• Ovid expects to conduct scientific advice meetings with the
European Medicines Agency (EMA)’s Committee for Medicinal Products
for Human Use (CHMP) during the second half of 2019 to discuss the
regulatory approval pathway for OV101 in Europe.
OV101 for Fragile X Syndrome
• The Phase 2 ROCKET trial continues to enroll patients and
results are expected around year-end 2019 or early 2020.
OV935 (soticlestat) for Rare Developmental and Epileptic
Encephalopathies (DEE)
• Ovid continues to enroll in the open-label extension ENDYMION
trial for individuals with DEE who previously completed a clinical
trial with OV935.
- Interim data from the ENDYMION trial are expected in the third
quarter of 2019.
• The open-label Phase 2 ARCADE trial in individuals with Dup15q
syndrome or CDKL5 Deficiency Disorder continues to enroll.
- Data from the ARCADE trial are expected in the first quarter of
2020.
• The global Phase 2 ELEKTRA trial in children with Dravet
syndrome or Lennox-Gastaut syndrome continues to enroll.
Ovid also plans to present additional details around its early
stage research programs during today’s R&D day event.
R&D Day Webcast A live audio webcast of
today’s R&D Day can be accessed through the Events &
Presentations section of the company's website at
investors.ovidrx.com. An archived replay of the webcast will be
available on the company's website for 90 days following the
event.
About Ovid TherapeuticsOvid Therapeutics
(NASDAQ: OVID) is a New York-based biopharmaceutical company using
its BoldMedicine™ approach to develop medicines that transform the
lives of patients with rare neurological disorders. Ovid has a
broad pipeline of potential first-in-class medicines. The company's
most advanced investigational medicine, OV101 (gaboxadol), is
currently in clinical development for the treatment of Angelman
syndrome and Fragile X syndrome. Ovid is also developing OV935
(soticlestat) in collaboration with Takeda Pharmaceutical Company
Limited for the potential treatment of rare developmental and
epileptic encephalopathies (DEE).
For more information on Ovid, please visit
http://www.ovidrx.com/.
Forward-Looking Statements This press release
includes certain disclosures that contain “forward-looking
statements,” including, without limitation, statements regarding
advancing Ovid’s product candidates, progress, timing, scope and
results of clinical trials for Ovid’s product candidates, and the
reporting of clinical data regarding Ovid’s product candidates. 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 Securities and
Exchange Commission under the caption “Risk Factors”. Ovid assumes
no obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Contacts
Investors and Media:Ovid Therapeutics Inc.
Investor Relations & Public Relationsirpr@ovidrx.com
OR
Investors: Steve KlassBurns McClellan,
Inc.sklass@burnsmc.com (212) 213-0006
Media:Katie Engleman1ABkatie@1abmedia.com(919)
333-7722
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