UK microcap faces partial clinical hold in mid-stage IPF trial
A tiny UK biotech is working on resolving a partial clinical hold from the FDA on some cohorts of its mid-stage trial, with the company saying the delay is unrelated to clinical data.
Redx Pharma said Thursday that US enrollment into 12-week cohorts of a Phase IIa study has not been able to get started, although there is an open IND in the US. CEO Lisa Anson — recruited in 2018 from AstraZeneca, where she served as the Big Pharma’s UK president for six years — told Endpoints News that the FDA is asking for specific data from a study in dogs.
“It’s a very specific kind of single observation that they want to see some further data on,” Anson said, also noting that the data the FDA wants should be coming out later this year.
The study is investigating RXC007 in idiopathic pulmonary fibrosis, a disease where the lung tissue gets scarred and breathing becomes progressively more difficult.
RXC007, an oral ROCK2 inhibitor, goes after the same target as Sanofi’s Rezurock. The French Big Pharma got its hands on the drug in 2021 when it bought Kadmon, which had brought the molecule past the FDA finish line, for $1.9 billion. Rezurock is currently indicated for adults and children at least 12 years old with chronic graft-versus-host disease (chronic GVHD).
Anson added that with Redx’s ROCK2 candidate, the biotech is looking at a broad swath of potential indications for RXC007. However, IPF is first.
“We’ll give further development updates later in the year,” Anson said. She also noted the potential for a ROCK2 inhibitor in pancreatic cancer, using it to target fibrosis and then enable chemotherapy to go after the tumor.
Redx added that the other dosing cohort in the Phase IIa IPF study, which is 28 days instead of 12 weeks, remains unaffected by the hold.