US patent covers brilaroxazine in treating IPF, like diseases
Potential therapy designed to modulate activity of two signaling molecules
Reviva Pharmaceuticals has been awarded a U.S. patent covering the use of its experimental therapy brilaroxazine in treating people with pulmonary fibrosis.
The patent, No. 12053477, granted by the U.S. Patent and Trademark Office specifically covers the use of brilaroxazine in idiopathic pulmonary fibrosis (IPF), as well as pulmonary fibrosis related to other conditions, including chronic obstructive pulmonary disease, sickle cell anemia, scleroderma, and lung cancer.
“This … patent builds on our existing IP [intellectual property] in pulmonary hypertension and is designed to maximize the value of brilaroxazine for the treatment of interstitial lung diseases,” Laxminarayan Bhat, PhD, founder, president, and CEO of Reviva, said in a company press release.
Brilaroxazine showed promising effects in lung disease models
Brilaroxazine is a novel chemical entity designed to modulate the activity of receptors for dopamine and serotonin, two key signaling molecules in the body. Within the brain, these signaling molecules help to control emotions, behaviors, and movements. Elsewhere in the body, dopamine and serotonin play key roles in regulating processes like fibrosis (scarring) and inflammation.
Abnormalities in serotonin signaling previously were implicated in the development of IPF and other lung disorders.
Brilaroxazine has shown promising effects in preclinical lab models of lung diseases, including IPF and pulmonary hypertension (PH) — a disease marked by high blood pressure in the vessels carrying blood from the heart to the lungs.
Reviva holds a similar patent in Japan covering the use of brilaroxazine for pulmonary fibrosis, and a patent in Europe for its use in treating forms of PH and pulmonary arterial hypertension.
“We are pleased to further expand our intellectual property (IP) for brilaroxazine which we believe has the broad therapeutic potential to treat inflammatory conditions like IPF driven by underlying disruption in serotonin signaling,” Bhat said.
The U.S. Food and Drug Administration previously named brilaroxazine, also known as RP5063, an orphan drug for the treatment of IPF. Orphan drug designation is given to therapies that are meant to treat rare diseases — defined as those affecting less than 200,000 people in the U.S. It aims to accelerate their development and regulatory review by conferring a series of incentives to developers, including exemption from certain fees, tax credits, and seven-year market exclusivity should the therapy be approved.
Reviva is also developing brilaroxazine as a potential treatment of schizophrenia — a mental health disorder marked by hallucinations (sensing things that aren’t real) and/or delusions (fixed beliefs with no basis in reality) — with positive results reported in a Phase 3 clinical trial.
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