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LONDON - Redx Pharma Limited presented new data from its Phase 2a study of zelasudil (RXC007) for idiopathic pulmonary fibrosis (IPF) at the European Respiratory Society meeting in Amsterdam on Monday.
The study evaluated the selective ROCK2 inhibitor in 48 IPF patients who received either zelasudil or placebo twice daily for 12 weeks, with some patients continuing into a 12-week open-label extension.
According to the company’s press release, zelasudil demonstrated numerical reduction in forced vital capacity (FVC) decline compared to placebo at 12 weeks, with a 47% reduction (58ml) at the 20mg twice-daily dose and a 13% reduction (16ml) at the 50mg twice-daily dose.
The drug was reportedly well-tolerated at both doses, with or without background antifibrotic therapy. No treatment-related serious adverse events were observed. The most common treatment-related adverse event was asymptomatic increases in liver enzymes (ALT/AST), which resolved with treatment interruption.
Professor Toby Maher, the study’s Chief Investigator and Director of the Interstitial Lung Disease Programme at Keck School of Medicine, University of Southern California, stated that zelasudil "has the potential to improve lung function in IPF patients" and noted that circulating biomarker data supported the compound’s anti-fibrotic activity.
The study also demonstrated that zelasudil could be combined with standard of care treatments pirfenidone or nintedanib without clinically relevant drug-drug interactions.
IPF is a progressive lung disease affecting over 170,000 patients globally, with approximately 53,000 new diagnoses annually across the US, five EU countries, and Japan. The condition has an estimated life expectancy of 3 to 5 years after diagnosis.
Redx Pharma is now seeking a partner to support further clinical development of zelasudil for IPF and other interstitial lung diseases.
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