(Alliance News) - PureTech Health PLC on Monday said its founded entity, Karuna Therapeutics Inc announced its phase 3 EMERGENT-3 trial of KarXT in Schizophrenia has met its primary endpoint.
The trial aimed to evaluate the efficacy, safety, and tolerability of KarXT in adults with schizophrenia.
The clinical-stage biotherapeutics company said that KarXT demonstrated an 8.4-point reduction in positive and negative syndrome scale total score at week 5, at negative 20.6, compared to negative 12.2 for the placebo.
The company said the reduction was "significant and clinically meaningful", adding that the treatment indicated early and sustained symptom reduction from week 2, through to the end of the trial.
KarXT was generally well tolerated, PureTech said, with a side effect profile consistent with prior trials.
PureTech said Karuna is on track to submit a new drug application to the US Food and Drug Administration in mid-2023, with the potential to launch the product in the second half of 2024.
At February 23, Puretech had a 3.1% interest in Karuna. PureTech has the right to royalties of 3% on net sales of any commercialised product covered by the licence agreement, and 20% sublicense income, as well as milestone payments.
Karuna Chief Executive Bill Meury said: "We look forward to working closely with the FDA as we focus our attention on the regulatory process, including our upcoming pre-NDA meeting in early second quarter, and remain on track for an NDA submission in mid-2023.
"The results from the EMERGENT-3 trial add to the growing body of data which suggest KarXT could address the symptoms of schizophrenia without the common side effects we see with current treatment options."
PureTech shares were flat at 203.50 pence each in London on Monday afternoon.
By Harvey Dorset, Alliance News reporter
Comments and questions to newsroom@alliancenews.com
Copyright 2023 Alliance News Ltd. All Rights Reserved.
PureTech (PRTC)