FDA approves PureTech’s KarXT to treat schizophrenia in adults

Puretech Health has obtained approval from the US Food and Drug Administration (FDA) for KarXT to treat schizophrenia in adults.

With this approval, the company is entitled to receive two separate payments totalling $29m from Royalty Pharma and Karuna Therapeutics, a PureTech Founded Entity now under Bristol Myers Squibb (BMS).

Cobenfy, the market name for KarXT, was developed by PureTech by combining xanomeline with trospium chloride.

This combination was designed to overcome tolerability challenges and introduce a new class of medicines for neuropsychiatric conditions.

PureTech co-founder and president Dr Eric Elenko said: “The FDA approval of Cobenfy is a significant milestone in our mission to transform the lives of patients with devastating diseases.

“Our initial hypothesis was that we could overcome the tolerability issues that had hindered the development of an otherwise promising drug, xanomeline, and we were able to test and validate this concept early on.”

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The financial implications of the FDA approval are substantial for PureTech. The company is set to receive approximately 2% in royalties on net annual sales exceeding $2bn.

Cobenfy’s success, including the proceeds from BMS’ acquisition of Karuna and an agreement with Royalty Pharma, has generated roughly $1.1bn for PureTech to date.

The proceeds from Cobenfy have allowed PureTech to self-fund the advancement of its pipeline, including LYT-100 or idiopathic pulmonary fibrosis, LYT-200 (anti-galectin-9 monoclonal antibody), and the Glyph platform via Seaport Therapeutics.

LYT-100 is a wholly owned programme by PureTech, following the same development strategy as Cobenfy to maximise the therapeutic potential of efficacious medicines with previous tolerability issues.

Topline data from the Phase IIb clinical trial of LYT-100 in IPF patients is expected by the end of the year.

Additional readouts from its oncology programme, including LYT-200, are also on the horizon.

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