First Healthy Volunteer Dosed in Phase 1 Trial of RXC007 for IPF

The first healthy volunteer has been dosed in a Phase 1 clinical trial evaluating RXC007, Redx Pharma’s investigational oral therapy for idiopathic pulmonary fibrosis (IPF) and other fibrotic, or scarring-related, conditions.

“The start of our first clinical study with RXC007 is an important milestone for Redx,” Lisa Anson, Redx’s CEO, said in a press release.

“We believe there is enormous potential for RXC007 to treat multiple fibrotic diseases and we will initially focus on idiopathic pulmonary fibrosis (IPF), a severe and life-threatening chronic lung condition with very poor prognosis and limited treatment options,” Anson said.

Redx’s lead anti-fibrotic candidate, RXC007 is an oral, highly selective small molecule that works by blocking ROCK2, an enzyme involved in a signaling pathway believed to be central to fibrosis and overly produced in fibrosis-related conditions, such as IPF. As such, RXC007 is thought to have the potential to treat IPF and other fibrotic diseases.

Previous preclinical studies support this, as the therapy was found to reduce fibrosis and lower the levels of pro-fibrotic and pro-inflammatory molecules in a range of animal models of lung fibrosis.

In addition, the selective suppression of ROCK2 is expected to prevent the side effects typically associated with other ROCK inhibitors that block both ROCK1 and ROCK2 enzymes.

Richard Armer, Redx’s chief scientific officer, said “the chemistry surrounding ROCK2 is complex and historically the identification of safe and effective selective inhibitors has proved challenging.”

“Using our distinctive and proven approach the Redx team has been able to generate what we believe will be a ‘best-in-class’ treatment for this unmet medical need,” Armer added.

The ongoing single-center Phase 1 trial is evaluating the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of RXC007, taken as an oral capsule once a day, in healthy volunteers. Pharmacokinetics refers to the therapy’s movement into, through, and out of the body.

Top-line results are expected in the first half of 2022, and will be used to inform a future Phase 2 trial, planned for the second half of 2022, to test RXC007 in IPF patients.

In addition to RXC007, Redx also developed another potential IPF treatment, called RXC006, whose global license rights were acquired by AstraZeneca in August 2020. RXC006 is a small molecule designed to block the activity of porcupine, a key enzyme in another signaling pathway involved in fibrosis.

Preclinical studies conducted by Redx showed that RXC006 reduced lung scarring in a mouse model. AstraZeneca now plans to advance the therapy into a Phase 1 clinical trial.