Pharmaceutical Alliance to Create Pediatric Epilepsy Drugs

TAK-935 will be developed to treat patients with rare pediatric epilepsy syndromes.

Takeda Pharmaceutical Company Limited and Ovid Therapeutics recently announced the creation of a novel collaboration focused on developing treatments for rare pediatric epilepsies.

The novel alliance will focus on the clinical development and commercialization of Takeda’s investigational drug TAK-935, which is a highly selective CH24H inhibitor, according to a press release.

The drug has already completed four phase 1 clinical trials under Takeda, which assessed tolerability and target doses. TAK-935 will next be evaluated in phase 1b/2a clinical trials in patients with rare epileptic encephalopathies, who currently do not have adequate treatment options.

Under the new agreement, Takeda will receive equity in Ovid, and will be entitled to milestone payments based on the advancement of the drug. Both companies will fund development and commercialization, and will equally share profits, according to the press release.

Takeda will focus on commercializing TAK-935 in Japan, and may choose to expand to other agreed upon locations, and Ovid will develop and commercialize the drug in the United States, Europe, Canada, and Israel.

An interdisciplinary team, composed of members from both companies, will oversee the successful advancement of the drug in rare pediatric epilepsies. The companies may decide to pursue other orphan central nervous system indications at a later time, according to the press release.

“Ovid’s agility, exclusive focus on developing therapies for rare neurological diseases and specialized capabilities in central nervous system drug development are highly differentiated and well suited to this important program,” said Emiliangelo Ratti, head of the central nervous system therapeutic area for Takeda Pharmaceuticals. “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. 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.”

The companies expect to start a phase 1b/2a clinical trial in 2017 in patients who have rare epileptic encephalopathies, such as Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.

Patients with these diseases are often diagnosed as infants and face significant morbidities, according to Takeda. While there are numerous effective therapies for epilepsy, there are limited treatment options for these disorders.

“Working together with Takeda we believe we can build on the strengths and interests of both companies. This is a creative alliance between a biotechnology and pharmaceutical company where not only do we both share the passion and commitment to develop meaningful medicines that may improve the lives of patients worldwide but also we are able to unlock value in both companies’ pipelines and talent,” said Jeremy Levin, DPhil, MB BChir, chairman and chief executive officer of Ovid Therapeutics. “This alliance advances our strategy to become a leader in the rare neurological disorders field. Building on our work with OV101 in Angelman and Fragile X syndromes, the collaboration in rare epilepsies extends our ability to help patient communities who face neurological conditions with limited to no therapeutic options.”