Redx Pharma has recently launched a new study assessing the safety, pharmacokinetics, pharmacodynamics, and activity of RXC007 for patients with idiopathic pulmonary fibrosis (IPF).

The study is currently recruiting up to 64 participants aged 40 to 80 years who will be administered RXC007 at 3 dose levels or placebo twice daily for up to 12 weeks.

The primary outcome measures of the trial are (1) the incidence and severity of adverse events and severe adverse events, (2) the number of participants who experience changes in normal laboratory safety parameters, (3) the number of participants who report changes in their vital signs, including blood pressure, heart rate, respiration rate and body temperature over 12 weeks, and (4) the number of participants who experience changes in normal range values for the 12-lead ECG parameters including heart rate, QT interval and QTcF interval in the 12-week study period.


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Secondary outcome measures include the assessment of a wide variety of pharmacokinetic parameters involving plasma concentration and elimination rates and changes in forced vital capacity and carbon monoxide diffusion capacity at 12 weeks.

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RXC007 is an oral selective inhibitor of Rho-associated protein kinase 2, known as ROCK2. It is believed to work by inhibiting a key cellular pathway in fibrosis progression in IPF and other fibrotic diseases. In addition, ROCK2 appears to suppress the expression of genes associated with fibrosis in IPF. Preclinical data on a mouse model of IPF showed reduced fibrosis, skin thickness, and collagen deposits in the mice.

Phase 1 study results demonstrated a good safety profile of RXC007, with no adverse events reported at once- or twice-daily doses from 2 mg to 70 mg.

The interventional, multicohort, randomized, placebo-controlled phase 2a study was launched on September 8, 2022, and is expected to be completed in April of 2024. The primary completion date is December 2023.

Reference

Study to assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of RXC007 in idiopathic pulmonary fibrosis. ClinicalTrials.gov. October 6, 2022. Accessed October 14, 2022.