Reviva to Seek Clearance for Phase 2 Trials of Brilaroxazine

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by Marisa Wexler MS |

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Reviva Pharmaceuticals is planning to seek the U.S. Food and Drug Administration’s (FDA) permission to begin Phase 2 clinical trials testing its investigational therapy brilaroxazine in people with idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH).

“We … expect to begin regulatory submissions to the FDA for pulmonary indications including IPF and PAH by the end of the first quarter of 2022,” Laxminarayan Bhat, PhD, Reviva’s founder, president, and CEO, said in a press release.

Formerly known as RP5063, brilaroxazine is designed to modulate serotonin signaling in the body. Serotonin is a signaling molecule that is perhaps best-known for its role as a neurotransmitter, or brain-signaling molecule, helping to regulate processes like mood and memory.

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Serotonin signaling also is involved in coordinating the activity of other bodily systems outside the brain, and abnormal serotonin signaling has been implicated in the development of pulmonary fibrosis (PF). According to Reviva, modulating serotonin signaling with brilaroxazine has the potential to delay disease progression in PAH and IPF.

The company has reported that treatment with brilaroxazine can reduce inflammation and tissue scarring in PF mice models.

Brilaroxazine was designated an orphan drug as a potential treatment for IPF by the FDA in 2018. This designation aims to promote the development of treatments that could improve care for rare conditions.

In addition to IPF and PAH, Reviva is developing brilaroxazine as a potential treatment for schizophrenia — a mental disorder characterized by hallucinations, delusions, and disordered, disruptive patterns of thinking and behavior.

The company has completed a Phase 2 trial (NCT01490086) that tested brilaroxazine against a placebo in 234 people with acute schizophrenia or schizoaffective disorder. That trial met its main goal — the treatment significantly reduced schizophrenia symptoms according to a standardized measure — and the therapy also was found to be generally safe and well-tolerated.

Reviva now is preparing to launch two Phase 3 trials to further evaluate the safety and efficacy of brilaroxazine in people with schizophrenia. If positive, results from those trials are expected to support future applications for regulatory approval.

“We look forward to initiating two Phase 3 trials evaluating both the efficacy and safety, as well as long-term safety of brilaroxazine in adults with schizophrenia by year-end,” Bhat said.