Redx Pharma PLC on Monday said its RXC007 drug has received orphan drug designation from the US Food & Drug Administration for the treatment of idiopathic pulmonary fibrosis, a condition causing breathing difficulty due to lung scarring.

The Macclesfield, England-based clinical-stage biotechnology company focused on discovering and developing targeted therapeutics for the treatment of fibrotic disease and cancer said the FDA orphan drug status offers Redx development and commercial incentives, including market exclusivity.

RXC007, marketed as zelasudil, is an orally administered protein inhibitor used to treat fibrosis.

Redx said RXC007 is currently undergoing a phase 2a clinical study for the treatment of IPF, with results expected in the first quarter of 2024.

Chief Medical Officer Jane Robertson said: ‘We are delighted that the FDA has recognised the potential of zelasudil for the treatment of IPF and granted orphan drug designation. Selectively targeting ROCK2 is an exciting, novel approach which could provide a new treatment option for patients with IPF, and with potential applications in other interstitial lung diseases and cancer-associated fibrosis.

‘We are encouraged by both the strength of our preclinical package as well as the clinical results to date and we look forward to reporting phase 2a topline data in Q1 2024.’

Shares in Redx rose 0.9% to 23.70 pence each on Monday morning in London.

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