Wellcome Trust awards $8m cash injection to trial schizophrenia drug

The Wellcome Trust has awarded $8 million to PureTech’s Karuna to take its schizophrenia drug into mid-stage trials.

Karuna, which is an affiliate of PureTech Health, was granted the funding towards the drug KarXT (Karuna-Xanomeline-Trospium), for its phase 2 clinical trial.

The trust previously awarded Karuna $3.8 million to fund a phase 1 tolerability proof-of-concept study with KarXT, which reported successful results. Both awards are structured in the form of unsecured convertible loans.

The side effects of drugs to treat schizophrenia are notorious, with twitching, weight gain, drowsiness, lack of sex drive, blurred vision and constipation among the most reported. These effects can be so intense for some patients that they stop taking their medication. Therefore, the drive to find treatments that are well tolerated is pressing.

Andrew Miller, president and CEO of Karuna, said: “Antipsychotics are the mainstay therapy for the treatment of schizophrenia and have all relied on the same fundamental mechanism of action for the past 60 years.

“Currently available treatments have limited efficacy – primarily addressing only positive symptoms, such as hallucinations and delusions – and are often associated with serious, often irreversible, side effects, leaving a significant need for new treatments for people living with this devastating disease.

“With KarXT, we have an opportunity to potentially improve positive, negative, and cognitive symptoms based on prior compelling efficacy data with xanomeline, and without the debilitating side effects of existing therapies.”

Schizophrenia affects more than 20 million people worldwide. It is usually described as a psychotic illness whereby patients cannot distinguish their thoughts from reality and often suffer delusions and hallucinations.

There is a desperate need for new treatments that not only address the symptoms, but that are safer than existing medicines.

Research into the condition is ongoing. Lundbeck and Otsuka Pharmaceutical announced earlier this month that the European Medicines Agency's CHMP regulatory committee issued a positive opinion on Rxulti (brexpiprazole) for the treatment of schizophrenia in adults.

This means the drug is likely to be on the EU market before autumn as the European Commission nearly always licenses drugs within a few months of a CHMP recommendation.

Meanwhile, Intra-Cellular Therapies is working on lumateperone, a first-in-class antipsychotic currently in development for the treatment of schizophrenia.

It has demonstrated broad symptom control and has been well tolerated with a safety profile similar to placebo without the motor or cardiovascular disturbances often associated with other antipsychotic medications.