April 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Rare disease startup Ovid Therapeutics is planning to go public and seeking to raise $86 million in its initial public offering to fund research on experimental therapies for Angelman Syndrome at Fragile X, as well as a therapy for epileptic encephalopathies.
In a filing with the U.S. Securities and Exchange Commission, Ovid said it intends to use the proceeds from the stock sale to conduct a Phase II trial for Angelman Syndrome and a Phase I trial for Angelman and Fragile X in adolescents, both using its OV101 therapy acquired from H/S Lundbeck for 1,052,977 Ovid shares and up to $181 million in milestone payments.
The Phase 1 single dose, single-arm, open-label, clinical trial of OV101 will measure PK parameters. The trial is expected to enroll adolescent patients, ages 13 to 17, who have been diagnosed with either Angelman syndrome or Fragile X syndrome. In addition to this clinical trial in adolescents, Ovid is planning to initiate clinical development in a pediatric population upon completing the required preclinical testing.
OV101 (gaboxadol) is a delta d--selective GABAA receptor agonist. The company believes this drug is the first to target the disruption of tonic inhibition. In preclinical models, OV101 has been able to selectively activate the d-subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and help regulate neuronal activity through tonic inhibition, according to Ovid data. Angelman syndrome is a rare genetic disorder associated with a reduction in tonic inhibition. Angelman affects approximately one in 12,000 to 20,000 people in the United States. There are currently no U.S. Food and Drug Administration-approved therapies for Angelman.
Amit Rakhit, chief medical and portfolio officer of Ovid, said the company’s goal is to provide treatments for patients of all ages diagnosed with Angelman and Fragile X.
“The initiation of this trial represents the first step in our strategy to develop OV101 for an adolescent population. This is an important step because having access to medicines at a younger age has the potential to have a transformative effect on the lives of these patients and their families,” Rakhit said in a statement.
In addition to the IPO funds being used for the Lundbeck drug, Ovid plans to initiate a Phase Ib/II trial of OV935 in patients with rare epileptic encephalopathies. Ov935 is an investigational drug being co-developed with Takeda Pharmaceuticals . The two companies inked a deal in January to develop the potent and highly selective CH24H inhibitor for use in rare pediatric epilepsies. BioSpace previously reported that Takeda carried TAK-935 (OV935) through a successful Phase I development. The drug will move into a Phase Ib/IIa study in rare epileptic encephalopathies, including Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex, where patients continue to suffer from significant unmet medical needs.
Ovid has applied to have its common stock listed on the Nasdaq Exchange under the symbol OVID. The company is helmed by Jeremy Levin a longtime biotech executive with histories at Bristol-Myers Squibb , Teva and Novartis . Levin holds about 27 percent of Ovid’s stock, making him the largest shareholder in the company, Endpoints reported this morning.
