Reviva announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for RP5063, its lead development product for the treatment of pulmonary arterial hypertension (PAH).

RP5063 is a new chemical entity (NCE) with a novel, multimodal modulation of dopamine and serotonin receptors. Serotonin signaling is reported to be involved in the pathogenesis of PAH and serotonin 5-HT2A/2B receptors expressed in the lungs are recognized as novel targets for therapies for the treatment of PAH. 

A previous Phase 2 study tested RP5063 in patients with schizophrenia and schizoaffective disorders, in which it demonstrated efficacy with remission in schizophrenia. It also demonstrated excellent safety and tolerability in the trial. 

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“Having already completed clinical studies phase 1, and phase 2 in patients with schizophrenia and schizoaffective disorders, we look forward to rapidly advancing this drug candidate into a phase 2 study in PAH patients,” said Marc Cantillon, MD, and CMO of Reviva.

There is currently no cure for PAH, and the current treatments only reduce symptoms whilst some may also delay disease progression.

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