Karuna workforce may grow
Schizophrenia drug awaiting approval
The Boston biotech Karuna Therapeutics, which is seeking approval of a novel drug for schizophrenia, is already talking about more than doubling its workforce next year if the Food and Drug Administration clears the new medicine.
Karuna, which began clinical trials of a first-of-its-kind schizophrenia drug called KarXT in 2016, has grown rapidly from about 20 employees in 2020 to more than 300 today. Should it win FDA approval, chief operating officer and cofounder Andrew Miller expects the workforce to jump to about 700.
“I don’t want to make it sound like we’re overconfident,” he said. “But I think we’re confident in the development plan we’ve executed and we’re preparing for the launch of KarXT in the second half of next year.”
KarXT uses a different mechanism than other antipsychotic drugs on the market. Medicines such as Zyprexa, Seroquel, and Abilify target dopamine and serotonin receptors in the brain. In contrast, KarXT stimulates muscarinic receptors in the same region and other areas of the brain to reduce symptoms of schizophrenia without the burdensome side effects of the older medicines, according to Karuna.
In clinical trials, Miller said, patients who received KarXT avoided such common side effects 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 they tended to pass.
By the end of November, Karuna expects drug regulators to decide whether to accept the application and, if they do, when they will rule on it, Miller said. He said the agency ruling would likely come in the second half of next year but he expected the hiring could begin months before that.
Karuna, founded in 2009, has had high hopes for KarXT. Like many other experimental drugs, the medicine has a backstory marked by abandonment, rediscovery, and serendipity, as Karuna’s then-chief executive, Dr. Steve Paul, told the Globe in 2019.
In the 1990s, when Paul was at Eli Lilly, the Indianapolisbased pharmaceutical giant tested a compound called xanomeline on patients with Alzheimer’s to see if it would improve memory. The compound appeared to provide some benefit. But what surprised Lilly researchers was that it dramatically reduced symptoms of psychosis, a notuncommon feature of Alzheimer’s.
That made the drug an appealing candidate to treat schizophrenia, a severe disease that causes hallucinations, delusions, and disorganized thinking and behavior. The problem was that xanomeline caused serious gastrointestinal side effects, including nausea and vomiting. Lilly ultimately shelved it.
Karuna, which was focusing on psychiatric and neurological conditions, combined xanomeline with another compound to dampen the medicine’s gastrointestinal side effects. That compound was trospium chloride, a drug that treats overactive bladders and has been on the market since the 1960s.
In a late-stage trial of 256 adults with schizophrenia, Karuna reported in March that recipients of KarXT experienced an 8.4-point reduction in symptoms, compared with recipients of a placebo on a scale of 30 features of the disease
David Walling, chief clinical officer at the clinical research company CenExel and an investigator in the trial, said the results “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.”
In a Sept. 28 news release announcing that Karuna had filed an application for approval of KarXT to the FDA, Bill Meury, president and chief executive of the company, said that if the agency clears the drug, it “will represent the first novel pharmacological approach to treating schizophrenia in several decades.”
Schizophrenia is a chronic and complex brain disorder that afflicts about 1 percent of the population, or more than 3 million Americans, according to the National Institute of Mental Health.