Plans for a Phase 2 clinical trial of brilaroxazine, the lead candidate by Reviva Pharmaceuticals to treat idiopathic pulmonary fibrosis (IPF), were the focus of a recent and successful meeting between company officials and the U.S. Food and Drug Administration (FDA), Reviva announced.
During this pre-Investigational New Drug (IND) Application meeting, the regulatory agency reviewed preclinical data and clinical Phase 1 study results into brilaroxazine, as well as Reviva’s plans for a Phase 2 safety and efficacy study in IPF patients.
FDA officials also addressed Reviva’s questions and provided guidance on the potential treatment’s continuing development.
“We are very pleased with the outcome of the pre-IND meeting with the FDA,” Laxminarayan Bhat, PhD, founder, president, and CEO of Reviva, said in a press release. “We look forward to initiating brilaroxazine Phase 2 study for IPF soon.”
Brilaroxazine, formerly known as RP5063, is an investigational compound designed to regulate serotonin signaling pathways.
In the brain, problems with serotonin signaling contributes to neurological diseases, But in the lungs, such dysfunction is associated with pulmonary fibrosis (PF) and pulmonary arterial hypertension (PAH). Serotonin signaling involving 5-HT receptors in the lungs are reported to cause vasoconstriction, vascular remodeling, and vascular inflammation, fibrosis, and other hallmark features of both IPF and PAH.
Preclinical work in mice models of pulmonary fibrosis has shown that treatment with brilaroxazine can effectively reduce inflammation and tissue scaring, suggesting its potential to improve and stabilize lung function, the company reports.
Brilaroxazine was designated an orphan drug as a potential IPF treatment by the FDA in 2018, an award that works to support and speed the therapy’s development and review for possible approval.
Reviva has completed a multicenter Phase 2 clinical study (REFRESH, NCT01490086) testing brilaroxazine in patients with schizophrenia and schizoaffective disorders.
Published trial results suggested that the therapy is effective in treating acute schizophrenia and neuropsychiatric symptoms, such as depression and mood, which are among comorbidities in people with IPF.
Brilaroxazine was also seen to be safe and well-tolerated compared to a placebo (non-active compound), not causing weight gain, neither metabolic, cardiac, or movement side effects.