Takeda Pharmaceutical said its rare pediatric epilepsy candidate TAK-935 will be co-developed through a collaboration with Ovid Therapeutics.
The value of the collaboration was not disclosed, though the companies did say Takeda received equity in Ovid and could receive payments tied to milestones in the advancement of TAK-935.
Takeda and Ovid said they will split development and commercialization costs 50/50 and share in the profits 50/50 should TAK-935 come to market. Ovid will lead clinical development activities and commercialization of TAK-935 in the U.S., Europe, Canada, and Israel, while Takeda will lead commercialization in Japan, with an option to lead in Asia and other unspecified regions of the world.
TAK-935 would be developed at least across rare epilepsy syndromes: “If mutually agreed, additional orphan central nervous system indications may also be pursued,” Takeda and Ovid said in a statement.
Central nervous system disorders are one of Takeda’s six core therapeutic areas, along with cardiovascular and metabolic, “general medicine” (gastrointestinal and genitourinary), oncology, respiratory and immunology, and vaccines.
“Takeda is driven by the urgent need to provide novel medicines for people with psychiatric, neurological, and rare central nervous system disorders for whom there are no treatments available,” stated Emiliangelo Ratti, Takeda’s head of the central nervous system therapeutic area. “This agreement is a prime example of our commitment to partnering select development programs with prominent companies that will enable us to remain at the leading edge of innovation.”
TAK-935 is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) and is set to advance later this year into Phase Ib/IIa clinical studies in patients with rare epileptic encephalopathies—including Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.
While treatments exist for epilepsy, few therapies exist for these disorders—an unmet medical need that Takeda and Ovid said they could address through TAK-935, which has successfully completed four Phase I studies by Takeda that have assessed tolerability and target engagement at doses believed to be therapeutically relevant.
“This alliance advances our strategy to become a leader in the rare neurological disorders field,” added Ovid Chairman and CEO Jeremy Levin, D.Phil., MB BChir. “The collaboration in rare epilepsies extends our ability to help patient communities who face neurological conditions with limited to no therapeutic options.”
Ovid’s lead candidate, OV101 (gaboxadol), is a delta (δ)-selective gamma-aminobutyric acid A (GABAA) receptor agonist being developed for Angelman and Fragile X syndromes. In September, the FDA granted its orphan drug designation to OV101 for Angelman syndrome—the indication for which Ovid says it will soon commence patient enrollment in the Phase II STARS clinical trial. Ovid plans to enroll approximately 75 people at least 18 years old with Angelman syndrome.