Redx Pharma PLC (AIM:REDX) announced that it will take its drug candidate for idiopathic pulmonary fibrosis (IPF) into phase II clinical trials after confirming its "excellent" safety profile.
Results from the initial study of RXC007 in healthy volunteers revealed there were no adverse events in the single-dose group.
No serious events were detected in the multiple-dose cohort either, though there were some “transient, reversible mild adverse events observed”.
The phase I evaluation is also designed to assess the pharmacokinetic profile of drugs such as RXC007 – in other words, how quickly and effectively they are absorbed and delivered to where they are required.
Again, the results from this portion of the trial were described as "excellent".
"Clinical data from our phase I study suggests that RXC007 is safe and well-tolerated at the drug doses we have selected,” said Redx chief executive Lisa Anson.
“Importantly, this data supports progressing into phase II studies later this year to assess the safety and efficacy of RXC007 in patients with idiopathic pulmonary fibrosis, a disease with high unmet medical need."
The phase II in IPF will begin later this year, Redx confirmed.
It will start with a 12-week randomised, placebo-controlled study to assess early efficacy, safety and tolerability.
Researchers will also look at target and disease biomarker engagement, both with and without the standard of care agents.
IPF is scarring of the lung and comes with a poor prognosis and limited treatment options.