Reviva Pharma's schizophrenia drug succeeds in late-stage study

[October 31, 2023]  By Mariam Sunny

(Reuters) -Reviva Pharmaceuticals' lead experimental drug to treat adults with schizophrenia helped reduce severity of disease symptoms in a late-stage study, sending the company's shares up nearly 8% on Monday.

Schizophrenia is a chronic mental disorder that causes distortion in thoughts, hallucinations and feelings of fright and paranoia.

In the study that involved 412 patients with acute schizophrenia, patients who were on Reviva's brilaroxazine recorded a total score of -23.9 on a medical scale used to measure the severity of schizophrenia symptoms.

Patients on placebo had a score of -13.8, which Reviva said was a "clinically meaningful" 10.1-point reduction.

The study also showed that 5.9% of patients who were administered brilaroxazine gained weight as a side-effect, while 2.9% of patients on placebo faced the issue, Reviva said.

The weight gain in the treatment group is "not reflective of a long-term outcome," CEO Laxminarayan Bhat said on a conference call with analysts.

Earlier this year, Karuna Therapeutics's lead experimental drug recorded an 8.4-point reduction of schizophrenia symptoms in the same scale, but the company flagged concerns of the drug causing hypertension in patients in a late-stage study.

Treatments approved in the United States for treatment of schizophrenia include anti-psychotic generic drugs such as risperidone and olanzapine.

Reviva said it plans to start another late-stage study for brilaroxazine in the first quarter of 2024 and file a marketing application to the U.S. Food and Drug Administration in 2025.

Brilaroxazine belongs to a class of drugs called serotonin-dopamine signaling modulator which regulates the levels of two chemical messengers in the brain, serotonin and dopamine.

(Reporting by Mariam Sunny in Bengaluru; Editing by Savio D'Souza)

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