Date: 2017-01-18
Type of information: Clinical research agreement
Compound: TAK-935
Company: Takeda Pharmaceutical (Japan) Ovid Therapeutics (USA - NY)
Therapeutic area: Rare diseases - CNS diseases - Neurological diseases
Type agreement: clinical research commercialisation
Action mechanism: enzyme inhibitor/CH24H inhibitor. TAK-935 is a first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase?CH24H). This enzyme is predominantly expressed in the brain, it converts cholesterol to 24-S-hydroxycholesterol which then exits the brain into the blood plasma circulation. TAK-935 has completed four Phase 1 clinical studies which have assessed tolerability and target engagement at doses which are believed to be therapeutically relevant.
Disease: rare pediatric epilepsies
Details: * On January 18, 2017, Takeda Pharmaceutical and Ovid Therapeutics announced the formation of a global collaboration focused on the clinical development and commercialization of Takeda’s investigational new drug TAK-935, a novel, potent and highly selective CH24H inhibitor, in rare pediatric epilepsies. TAK-935 has successfully completed several Phase 1 clinical studies under Takeda’s leadership and will be moving into Phase 1b/2a clinical studies in rare epileptic encephalopathies where patients continue to suffer from significant unmet medical needs. Takeda Pharmaceutical and Ovid Therapeutics expect to initiate a Phase 1b/2a study in 2017 in patients with rare epileptic encephalopathies including Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.
Financial terms: Under the terms of the agreement, Takeda received equity in Ovid and may be eligible to receive certain milestone payments based on the advancement of TAK-935. The companies will share in the development and commercialization costs on a 50/50 basis and, if successful, the companies will share in the profits on a 50/50 basis. Takeda will lead commercialization in Japan, and has the option to lead in Asia and other selected geographies. Ovid will lead clinical development activities and commercialization of TAK-935 in the United States, Europe, Canada and Israel. All activities of the collaboration regarding TAK-935 will be guided by the Takeda/Ovid “One Team” concept, an integrated and interdisciplinary team from both companies devoted to the successful advancement of TAK-935 across rare epilepsy syndromes. If mutually agreed, additional orphan central nervous system indications may also be pursued. Additional financial details were not disclosed.
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