FDA Grants Orphan Designation to Investigational Idiopathic Pulmonary Fibrosis Treatment

Officials with the FDA granted orphan drug designation for Reviva Pharmaceuticals’ clinical stage drug candidate, RP5063 for treatment of idiopathic pulmonary fibrosis (IPF).

The drug has shown robust efficacy in highly recognized translational animal models proven to emulate pulmonary fibrosis in humans, significantly improving survival rate and reducing inflammatory cytokines and fibrosis in the lungs of bleomycin-induced pulmonary fibrosis animal model.

The findings indicate the potential for a clinically meaningful improvement and stabilization of lung function.

“Obtaining the Orphan Drug Designation is a significant regulatory milestone as well as a notable achievement for Reviva, since it validates the significant therapeutic potential of RP5063 for the treatment of IPF,” Laxminarayan Bhat, PHD, found, president, chief executive officer, Reviva, said in a statement.

The new chemical entity involves a novel mechanism of multimodal modulation of serotonin and dopamine signaling pathways. A potent inhibitor of the 5-HT2A/2B/7 receptors, RP5063 weakens functional changes in a series of well recognized translational animal models proven to emulate pulmonary fibrosis and pulmonary arterial hypertension.

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