PureTech health finishes tolerability testing of KarXT for schizophrenia and Alzheimer’s

Karuna Pharmaceuticals and a subsidiary of PureTech Health have finished studying antipsychotic for schizophrenia and Alzheimer’s disease – KarXT.

The company on Thursday said that KarXT (xanomeline plus trospium chloride) was found to be generally well-tolerated and have superior tolerability to xanomeline alone.

Based on these results and previous efficacy data on xanomeline, which is exclusively licensed to Karuna from Eli Lilly, Karuna said it aims to start a Phase 2 clinical trial of KarXT in 2017.

According to Andrew Miller, Karuna’s CEO, KarXT approach improves the tolerability of xanomeline and represents a step closer toward developing the first novel antipsychotic agent in more than sixty years for schizophrenia or Alzheimer’s patients.

Miller said:  “Given the strong efficacy data shown in previous clinical trials with xanomeline, our goal was to demonstrate the improved tolerability of KarXT compared to xanomeline.  Now we look forward to initiating a Phase 2 trial in 2017 to replicate the efficacy previously observed with xanomeline with this greatly improved product profile.” 

Alan Breier, Karuna Chief Clinical Advisor, and former Chief Medical Officer at Eli Lilly noted that the tolerability data reported in this study, together with the previous compelling efficacy data generated with xanomeline, show that this is a new way to target muscarinic receptors and develop the medicine.

“Patients with Alzheimer’s and schizophrenia are in dire need of new treatments, and KarXT may offer a potentially transformative new path towards treating these serious and debilitating diseases,” said Breier.