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NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to improving the lives of people affected by rare epilepsies and brain conditions, today announced that management will participate in two upcoming investor conferences in September: H.C. Wainwright 26th Annual Global Investment Conference – Ovid will present on September 10th at 3:30 p.m. ET.Cantor Global Healthcare Conference – Ovid will participate in a fireside chat on Tuesday, September 17th at 1:55 p.m. ET. Live webcasts of the fireside chat and presentation 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 following the live presentation. About Ovid TherapeuticsOvid Therapeutics Inc. is a New York-based biopharmaceutical company that is dedicated to improving the lives of people affected by rare epilepsies and brain conditions with seizure symptoms. The Company is advancing a pipeline of novel, targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of seizures and other neurological symptoms. Ovid is developing: OV888/GV101 capsule, a potent and highly selective ROCK2 inhibitor, for the potential treatment of cerebral cavernous malformations and other rare central nervous system diseases; OV329, a GABA-aminotransferase inhibitor, a potential therapy for treatment-resistant seizures; and OV350, a direct activator of the KCC2 transporter, for the potential treatment of epilepsies and other psychiatric conditions. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Investor Relations:Garret Bonney617-735-6093gbonney@ovidrx.com

Recursion’s share price opened down 10% at $6.55. Recursion has stumbled through an early test of its tech-enabled approach to drug discovery, reporting a hit on its phase 2 primary endpoint of safety and tolerability but failing to wow on the efficacy front.The study evaluated REC-994 in people with symptomatic cerebral cavernous malformation (CCM), a rare disease characterized by lesions that increase the risk of seizures, progressive neurological deficits and potentially fatal stroke. The first version of Recursion’s platform identified a superoxide scavenger as a molecule that may alleviate neurological symptoms and slow lesion accumulation, leading to REC-994.Investigators put the idea to the test by randomizing 62 patients to take REC-994 or placebo in a phase 2 study. Recursion saw a similar safety and tolerability profile across the placebo group and two REC-994 doses over 12 months of treatment, causing the study to meet its primary endpoint.The efficacy data are less compelling. Recursion said MRI scans showed “a trend towards reduced lesion volume and hemosiderin ring size” at the higher REC-994 dose compared to placebo. Hemosiderin is a protein that surrounds more advanced, bleeding cavernous malformations and is seen on MRI. Recursion saw no improvements on patient-reported outcomes (PROs), or physician-led measures, after 12 months of treatment. Talking on an earnings call in August, Najat Khan, Ph.D., chief R&D officer at Recursion, said MRI-based endpoints and PROs, plus biomarkers, were the three efficacy areas the biotech was focusing on. Khan said the PROs “are extremely important to patients.”The biotech continues to see a future for the molecule and plans to talk to the FDA about an additional trial. Recursion is at the forefront of efforts to treat CCM, but rivals are on its tail, with Ovid Therapeutics preparing to move a ROCK2 inhibitor into phase 2 and Neurelis pushing a candidate through phase 1.Recursion’s share price opened down 10% at $6.55. The biotech has upcoming chances to improve perceptions, with its pipeline featuring multiple readouts and an agreed merger with Exscientia set to add more assets. 

The oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of Ovid Therapeutics' top priorities. Ovid Therapeutics already revealed last month that it was trimming back its headcount as the company navigates an unexpected setback for the Takeda-partnered epilepsy med soticlestat. Now, the biotech has confirmed that it’s halting work on its preclinical programs, including an intravenous (IV) formulation of its seizure drug in order to save cash.The company already made clear in a regulatory filing at the time that laying off 17 people—equivalent to 43% of Ovid’s workforce—in July was spurred by a need to “prioritize its programs and extend its cash runway.”In its second-quarter earnings report this morning, the biotech spelt out what pipeline changes it had in mind. The company is halting its preclinical work—although the only high-profile casualty will be the IV formulation of OV329.While Ovid also referred to “other preclinical programs” as facing the axe, it didn’t go into further details.Instead, the oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of the company’s top priorities. A phase 1 multiple ascending dose study is expected to wrap up this year. The other key priority for Ovid is OV888/GV101, a Graviton Bioscience-partnered ROCK2 inhibitor capsule that is being lined up for a phase 2 study in cerebral cavernous malformations. With $77 million to hand in cash and equivalents, the company expects to pave a cash runway into 2026.Ovid CEO Jeremy Levin put the pipeline changes in the context of the failure of soticlestat to reduce seizure frequency in patients with refractory Lennox-Gastaut syndrome, a severe form of epilepsy, in a phase 3 trial in June. Ovid sold its rights to the cholesterol 24 hydroxylase inhibitor to Takeda for $196 million back in 2021 but is still in line for commercial milestones and low double-digit royalties up to 20% on global net sales.“Following Takeda's unexpected phase 3 results for soticlestat, we moved rapidly to focus our resources to preserve capital,” Levin said in today’s release. “This approach included restructuring the organization and initiating ongoing program prioritization efforts to support the achievement of meaningful clinical and regulatory milestones within our financial plan.”Takeda was also taken aback by soticlestat’s failure. The Japanese pharma notched a $140 million impairment charge as a result of the phase 3 miss. Still, Takeda said recently that it still holds some hope that the “totality of the data” could one day earn an FDA nod anyway.