Pharmaceutical company Reviva Pharmaceuticals Inc on Friday announced a successful a pre-Investigational New Drug (IND) Application meeting with the US Food and Drug Administration (FDA) for the IND development plan of brilaroxazine as well as guidance for launch of its phase 2 clinical study.

The company added that the US FDA has recently granted Orphan Drug Designation to brilaroxazine for treating patients with Idiopathic Pulmonary Fibrosis (IPF).

In the Pre-IND Meeting, the US FDA has reviewed the company's brilaroxazine IND enabling preclinical data and clinical phase 1 study results and phase 2 study plan for IPF. The US FDA addressed the questions and provided guidance on the brilaroxazine clinical development plan for IPF.

According to the company, Brilaroxazine is a new chemical entity (NCE) that acts on serotonin signaling pathways. Serotonin signaling derived from activated 5-HT2A/2B/7 receptors in the lung mediates inflammation, fibrosis and proliferation, and pulmonary hypertension. Brilaroxazine is a potent inhibitor of the 5-HT2A/2B/7 receptors and attenuates these functional changes in highly recognized translational animal models proven to emulate IPF and PAH conditions in humans.

IPF is a progressive, debilitating and fatal lung disease characterised by inflammation and fibrosis of the lungs, hindering the ability to process oxygen and causing shortness of breath.