Following the news that Karuna Therapeutics has announced the Phase III Clinical Trial results of KarXT for acute psychosis in patients with schizophrenia;

Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“KarXT, with its novel mechanism of action that targets central nervous system (CNS) indications, represents a large and underserved patient population characterized by psychosis and cognitive impairment. KarXT is a muscarinic acetylcholine receptor (mAChR) agonist at M1, M4 and by binding to the muscarinic receptors, the drug candidate increases striatal acetylcholine levels resulting in reduced psychosis and improved cognition. The drug’s clinical trial results showed that it was well tolerated and could  provide a new treatment option for people affected by the disease – as in many patients approved antipsychotics offer modest efficacy and significant side effects.

“According to GlobalData, there are fifteen candidates in the late-stage schizophrenia pipeline that are expected to launch in the next ten years in the seven major markets (7MM*). Three of these late-stage drug candidates are in pre-registration, namely ITI-007 (lumateperone tosylate), Latuda (lurasidone HCL), and Rykindo (risperidone ER) with the last two being a reformulation of marketed drugs to increase compliance and provide a better safety profile and way of administration. Additionally, there are also 18 candidates in Phase II and 24 in Phase I. Latuda is in pre-registration stage in Japan, but has been approved in the US.

“However, these products can face competition from atypical anti-psychotic products, as these drugs have dominated the market in terms of sales revenue for over a decade, which is why there is a need for new players to develop novel therapeutic options.

“The current schizophrenia treatment landscape includes a high number of established atypical anti-psychotic products that can effectively manage the positive symptoms of the disorder. However, there is a significant unmet need for novel, effective treatment options that address the negative symptoms and cognitive impairments seen in schizophrenia.”

*7MM = US, France, Germany, Italy, Spain, UK and Japan