10 clinical trials to watch in the second half of 2022
The value of Karuna Therapeutics, a Boston-based developer of brain drugs, rose by billions of dollars in late 2019, after its most advanced experimental medicine scored positive results in a schizophrenia study.
The study, which enrolled about 180 participants, showed that those taking Karuna’s medicine, known as KarXT, experienced significant reductions in the severity of their symptoms compared to those given a placebo. Karuna also said KarXT was well tolerated, an important finding given that one of the drug’s active ingredients caused concerning side effects in clinical trials a few decades ago.
Karuna now hopes to build the case for its drug through two larger clinical trials — the first of which, named EMERGENT-2, should produce results by the end of September. The trial, which is evaluating nearly 250 adult patients with schizophrenia over a five-week period, finished enrollment this spring.
In a recent note, Jefferies analyst Chris Howerton wrote that his team puts the odds the trial succeeds at 75%. If KarXT goes on to secure FDA approval, Howerton claims it should have “no issue” surpassing $1 billion in annual sales.
Historically, pharmaceutical companies have struggled to develop treatments for psychiatric disorders. The last few years have seen drugs from Neurocrine Biosciences and Acadia Pharmaceuticals fail as potential treatments for schizophrenia.
Yet, there have also been several victories. Pfizer’s neuroscience spinout, Cerevel Therapeutics, in late 2019 posted positive results from an early-stage trial of its experimental schizophrenia medicine. The Food and Drug Administration also approved two new schizophrenia medicines — one from Intra-Cellular Therapies, the other from Alkermes — in 2019 and 2021, respectively.
Karuna expects EMERGENT-3, its other schizophrenia study and a trial delayed by the war in Ukraine, to produce results in early 2023. The company also intends to start a late-stage program this year evaluating its drug as a treatment for psychosis in patients with Alzheimer’s disease.
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