KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Karuna Therapeutics, Inc. (Nasdaq: KRTX) ("Karuna") announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia.

“We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia. KarXT, which was invented at PureTech, showcases how we invent and advance novel medicines by giving new life to drugs that have validated pharmacology but had previously not reached patients due to an issue that is now addressable with our innovations. This NDA submission is also an important milestone for patients, as it could represent the first major advance for treating schizophrenia in over 50 years if approved by the FDA,” said Eric Elenko, Chief Innovation Officer at PureTech.

The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the ongoing EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT. In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. KarXT also demonstrated reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS negative Marder factor subscales, which were secondary endpoints in the trials.

As a founder of Karuna and co-inventor of the KarXT program, PureTech retains an equity ownership and has rights to receive milestone payments upon the achievement of certain regulatory approvals and 20% of sublicense income.¹

If approved, KarXT will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.

The full text of the announcement from Karuna is as follows:

Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

KarXT, a dual M1/M4 muscarinic agonist, represents the first new mechanism of action to treat schizophrenia in several decades, if approved