Promising Clinical Trial Updates in IPF/PPF

It is important to explore the extended safety profile as well as the long-term efficacy of new drugs in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), says Toby Maher, MD, PhD, professor of clinical medicine, Keck Medicine of USC.

Transcript

Can you discuss the design of the FIBRONEER-ON open-label extension trial?

The FIBRONEER-ON open-label extension trial is a follow-on from 2 clinical trials, the FIBRONEER trial in patients with idiopathic pulmonary fibrosis and the FIBRONEER trial in patients with progressive pulmonary fibrosis. Both of those studies contain over 1000 participants per trial. In those trials, patients are on either placebo or 1 of 2 doses of nerandomilast, which is a PDE4B inhibitor. In the FIBRONEER-ON trial, we're going to be rolling patients over from those 2 trials so that everybody receives open-label treatment with neradomilast. What we're looking for in that trial is to understand the extended safety profile of the drug and at the same time, to also try and gain further understanding about long-term efficacy.

What were the key findings regarding the effects of lysophosphatidic acid receptor 1 (LPA1) antagonism with BMS-98627 on biomarkers in patients with IPF and PPF?

Thankfully, they've given that drug a name; it's now admilparant. It's an LPA receptor 1 antagonist. There's good preclinical evidence that the LPA receptor pathway plays an important role in driving fibrosis. In that particular trial, that was a phase 2b trial where we explored 2 doses of treatment compared to placebo, in 2 separate cohorts of patients; 1 group who had idiopathic pulmonary fibrosis, the other group who had progressive pulmonary fibrosis. We looked at both sets of patients separately, but the results were pretty consistent across both groups. The higher dose of admilparant, the 60-mg daily dose, appeared to slow the rate of FVC [forced vital capacity] decline compared to placebo, and that was over 6 months of treatment. And so, as a phase 2 study, that really was to allow us to make the decision about going into phase 3, and there are now separate clinical trials at phase 3 looking at admilparant in patients with either IPF or progressive pulmonary fibrosis.