Redx Pharma has announced positive preclinical results for RXC007, a selective inhibitor of Rho-associated protein kinase 2, which is being developed to treat lung fibrosis in idiopathic pulmonary fibrosis (IPF) and autoimmune-related interstitial lung disease.
“We are excited by this new preclinical data which supports our current and future clinical development plans. RXC007 has now shown anti-fibrotic effects in a range of preclinical models which, combined with the encouraging phase 1 safety and pharmacokinetic profile, underpins our plan to commence a phase 2a trial in IPF during Q4 2022. IPF only accounts for about a third of patients who have significant fibrotic lung pathology, and this new preclinical data supports broader clinical development of RXC007 in lung fibrosis including progressive fibrotic interstitial lung disease, which we intend to explore during our future phase 2b study,” said Jane Robertson, MD, chief medical officer of Redx.
Oral RXC007 reduced skin thickness, fibrosis, and collagen deposition in the skin and lungs of mice. In addition, data from a phase 1 study in healthy volunteers suggested excellent safety and pharmacokinetic profiles. No adverse events were observed in the single ascending dose phase, and only transient, reversible, mild adverse events were reported in the multiple dose phase.
Moreover, biologically relevant exposures were achieved from 20 mg, and the half-life was approximately 9 to 11 hours. Drug exposure was not affected by food intake.
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The results were presented as a poster at the International Colloquium on Lung and Airway Fibrosis in early October.
A 12-week randomized placebo-controlled phase 2a study to evaluate early efficacy, safety, and tolerability of RXC007 in IPF is planned to start at the end of the year, with top line data expected in the second half of 2023.
Redx presents preclinical data confirming anti-fibrotic effects of RXC007 in immune mediated models, and final phase 1 safety data. News release. Redx Pharma PLC; October 3, 2022.