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Ovid Therapeutics Receives “Company Making a Difference Award” from CDKL5 Deficiency Disorder Community | ||
By: Nasdaq / GlobeNewswire - 22 Oct 2018 | Back to overview list |
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NEW YORK, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced it has received the 2018 CDKL5 Forum Company Making a Difference Award for initiation of the Phase 2 ARCADE trial with OV935/TAK-935, and its commitment to the CDKL5 deficiency disorder (CDD) patient community. The award was announced today in London, UK at the CDKL5 Forum, the largest annual conference on the advancement of science and therapeutic development for CDD. CDD is a rare, severe, neurological disorder that causes frequent, treatment-resistent seizures in the first few months of life. CDD results in a constellation of severe challenges, including developmental delay and intellectual disability, movement disorder, difficulty sleeping, scoliosis, visual impairment, microcephaly and various gastrointestinal difficulties. There are currently no FDA-approved therapies for CDD. “We hand out the Company Making a Difference Award annually to recognize industry partners for their commitment and support, and this year we are pleased to recognize the team at Ovid Therapeutics,” said Ana Mingorance, Ph.D., chief development officer of Loulou Foundation. “Since the day Ovid selected CDD as a condition to pursue, they have shown amazing support and care for our community, and we are excited to partner with such a human-centric organization.” The ARCADE trial is a Phase 2 multi-center, open-label, pilot study designed to evaluate the treatment of OV935 in pediatric patients with epileptic seizures associated with CDD or Duplication 15q (Dup15q) syndrome. The first patients have already been enrolled into ARCADE. This study is part of a global collaboration with Takeda Pharmaceutical Company Limited. “We are honored to be recognized for our dedication and efforts to bring a novel treatment option to the clinic for those with CDD and other rare epilepsies,” said Amit Rakhit, M.D., MBA, chief medical and portfolio management officer of Ovid Therapeutics. “It was important to everyone at Ovid that I travel to London to accept this award to show our unwavering support and partnership with the CDD community. We thank LouLou Foundation and the community and look forward to providing updates on our progress with the ARCADE study.” The CDKL5 Forum is a unique community of collaboration and knowledge exchange, made up of leading scientists, clinicians and company representatives from around the world, united in the mission of better understanding the CDKL5 gene and disorder. The objective is to share current research on CDKL5 and to stimulate peer-group discussion and brainstorming around existing and future avenues of research and therapeutic approaches, in order to accelerate treatments and ultimately find cures for this neuro-genetic disorder. Now in its fourth year, the Forum represents the flagship annual event of the CDKL5 Program of Excellence, established by the Loulou Foundation and the Orphan Disease Center of the University of Pennsylvania’s Perelman School of Medicine. About the ARCADE Trial ARCADE is expected to enroll approximately 15 children with each condition at clinical trial sites in the United States. This study consists of a four to six week screening period to establish baseline seizure frequency followed by a 12-week treatment period (2-week dose titration and 10-week maintenance period.) To learn more about ARCADE visit clinicaltrials.gov or www.arcadestudy.com. At the end of treatment, eligible patients can roll over into the ENDYMION study. Additional details on the ENDYMION clinical trial can be found at www.clinicaltrials.gov. About Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (CDD) About Duplication 15q (Dup15q) Syndrome About Investigational OV935/TAK-935 OV935 has successfully completed four Phase 1 clinical studies, which have assessed tolerability, PK and target engagement at doses believed to be therapeutically relevant. In preclinical models, a novel proprietary PET ligand was used to determine target occupancy of OV935 in the brain. OV935 is being co-developed by Ovid and Takeda Pharmaceutical Company Limited. The United States Food and Drug Administration (FDA) has granted orphan drug designation to OV935 for the treatment of both Dravet syndrome and LGS. About Ovid Therapeutics For more information on Ovid, please visit http://www.ovidrx.com/. Forward-Looking Statements Contacts: Media: |
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