Karuna plans to more than double staff if schizophrenia drug approved – The Boston Globe

I don’t want to give the impression that we are too confident, he said. But I think we were confident in the development plan that we executed and were preparing to launch KarXT in the second half of next year.

KarXT uses a different mechanism than other antipsychotic medications on the market. Medications such as Zyprexa, Seroquel and Abilify target dopamine and serotonin receptors in the brain. On the other hand, KarXT stimulates muscarinic receptors in the same region and other areas of the brain to reduce symptoms of schizophrenia without the bothersome side effects of older medications, according to Karuna.

In clinical trials, Miller said, patients who received KarXT avoided common side effects such as weight gain, drowsiness and tardive dyskinesia, an involuntary movement disorder. The drug did, however, cause mild to moderate gastrointestinal side effects in some patients, but these tended to disappear.

By the end of November, Karuna expects drug regulators to decide whether to grant the request and, if they do, when they will rule, Miller said. He said the agency’s decision would likely come in the second half of next year, but he expected recruiting could begin months before then.

Karuna, founded in 2009, had high hopes for KarXT. Like many other experimental drugs, this drug has a history marked by abandonment, rediscovery and chance, as Karunas points out. then-director general Dr. Steve Paul told the Globe in 2019.

In the 1990s, when Paul worked at Eli Lilly, the Indianapolis-based pharmaceutical giant tested a compound called xanomeline on Alzheimer’s patients to see if it would improve memory. The compound appears to provide some benefits. But what surprised the Lilly researchers was that it significantly reduced symptoms of psychosis, a fairly common feature of Alzheimer’s disease.

This made the drug an attractive candidate for treating schizophrenia, a serious illness that causes hallucinations, delusions and disorganized thinking and behavior. The problem was that xanomeline caused serious gastrointestinal side effects, including nausea and vomiting. Lilly finally put it aside.

Karuna, who focused on psychiatric and neurological disorders, combined xanomeline with another compound to alleviate the drug’s gastrointestinal side effects. That compound was trospium chloride, a drug that treats overactive bladder and has been on the market since the 1960s.

In a late-stage trial of 256 adults with schizophrenia, Karuna reported in March that KarXT recipients experienced an 8.4-point reduction in symptoms, compared to placebo recipients on treatment. scale of 30 characteristics of the disease

David Walling, clinical director of clinical research company CenExel and trial investigator, said the findings add to the growing body of data that suggests KarXT could treat symptoms of schizophrenia without the common side effects that we let’s observe with current treatment options.

In a September 28 press release announcing that Karuna had filed an application for approval of KarXT with the FDA, Bill Meury, the company’s president and CEO, said that if the agency authorizes the drug, he will represent the first new pharmacological approach. to the treatment of schizophrenia in several decades.

Schizophrenia is a chronic, complex brain disorder that affects about 1 percent of the population, or more than 3 million Americans, according to the National Institute of Mental Health.

Jonathan Saltzman can be contacted at jonathan.saltzman@globe.com.