Shares of Ovid Therapeutics Inc. (OVID:NASDAQ) are trading more than 25% higher after the company yesterday announced positive initial data from its ENDYMION study. The ENDYMION trial is a Phase 2 open-label extension study of soticlestat (OV935/TAK935) in patients with rare developmental and epileptic encephalopathies (DEE). DEE is a heterogeneous group of rare highly-refractory epilepsy syndromes and encompasses Dravet syndrome, Lennox-Gastaut syndrome (LGS) and others. The firm claims that soticlestat is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), which is being investigated as a novel approach to treating adults and children with rare epilepsies in collaboration with Takeda Pharmaceutical Co. Ltd. (4502:JP).
The firm advises that the initial data from the ENDYMION open-label extension trial is from patients who previously completed Ovid's 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE. The study findings revealed that "at 12 weeks, 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."
Amit Rakhit, MD, MBA, chief medical officer and head of research and development at Ovid, commented, "While this first data cut includes a small number of patients, these initial results from ENDYMION reaffirm the potential of soticlestat to provide a tangible and durable clinical benefit for patients with DEE, a group of difficult-to-treat seizure disorders with limited therapeutic options...Specifically, we believe the sustained and progressively improving median seizure reduction up to 90% seen in these patients is encouraging and, while early, compares favorably to other studies in different types of DEE. We look forward to additional progress in our broad DEE clinical development program including initial data from the ARCADE study expected in Q1/20 and topline results from the randomized ELEKTRA study now expected in H2/20 as a result of robust enrollment."
Ovid explains that ENDYMION's primary objective is to assess the long-term safety and tolerability of soticlestat over two years of treatment in patients with rare epilepsies and, secondarily, to evaluate the effect of soticlestat on seizure frequency over time. The firm noted that in terms of overall seizure free interval during treatment, one patient experienced 264 consecutive days and one patient experienced 150 consecutive days without a seizure. Ovid also pointed out that overall, safety findings are consistent with prior observations in the 12-week Phase 1b/2a adult DEE study and that soticlestat continues to show a favorable safety and tolerability profile.
The company states that that soticlestat (OV935/TAK-935) is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. To Ovid's knowledge, soticlestat is the only molecule with this mechanism of action in clinical development as an anti-epileptic drug. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to soticlestat for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome (LGS).
Ovid and Takeda entered into a global development and commercialization collaboration in January 2017 to evaluate soticlestat across a range of rare epilepsy syndromes. In addition to the ENDYMION study, Ovid and Takeda are also conducting the Phase 2 ARCADE and ELEKTRA trials in pediatric DEE patient populations. The company identifies the ARCADE study as a Phase 2, multi-center, open-label, pilot study that will evaluate the treatment of soticlestat in patients with refractory epileptic seizures associated with CDKL5 Deficiency Disorder (CDD) or Dup15q syndrome. It further advises that the ELEKTRA study is an international Phase 2, multi-center, randomized, double-blind, placebo-controlled study that will evaluate the treatment of soticlestat in pediatric patients with epileptic seizures associated with Dravet syndrome or Lennox-Gastaut syndrome (LGS).
Ovid Therapeutics is headquartered in New York City and describes itself as a biopharmaceutical company using its BoldMedicine approach to develop medicines that transform the lives of patients with rare neurological disorders. The firm states that it has a broad pipeline of potential first-in-class medicines. The company advises that its most advanced investigational medicine OV101 (gaboxadol) is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome.
Ovid Therapeutics began today with a market cap of approximately $96.5 million. The firm's shares opened today at $2.60 (+$0.13, +5.26%) over the prior day's $2.47 closing price. The stock has traded today between $2.60 and $3.48/share and presently is trading at $3.14 (+$0.67, +27.13%).
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