Idiopathic Pulmonary Fibrosis Treatment

Idiopathic Pulmonary Fibrosis (IPF) is a fatal interstitial lung disease. As the morbidity and mortality rates associated with IPF remain high, prompt treatment of IPF is critical to safeguard individuals’ lung function, reduce the risk of acute exacerbations, and improve outcomes. There are currently only two FDA-approved drugs for the treatment of IPF, which include Esbriet (cytokine inhibitor) developed by Hoffmann-La Roche, and Ofev (tyrosine kinase inhibitor) developed by Boehringer Ingelheim.

With prior experience in the treatment of IPF, Boehringer is accelerating the development of another drug named BI 1015550 with a novel mechanism of action to treat IPF patients. BI 1015550 represents the first molecule in the class of phosphodiesterase 4B (PDE4B) inhibitors that is being studied for IPF and other progressive fibrosing interstitial lung diseases (ILDs). The drug has combined anti-fibrotic and anti-inflammatory effects. It recently received Breakthrough Designation by the US FDA in February 2022 to treat IPF.

At the recently held American Thoracic Society (ATS) International Conference, the company has published the safety and efficacy of BI 1015550 18 mg twice daily in patients with IPF (Phase II (NCT04419506)). In the 12-week data, the drug has shown promising results in both the groups i.e. rate of lung function decline in patients who were not on approved antifibrotics, as well as those who were taking existing antifibrotic therapy.

The primary study outcome was the change in FVC (measured in mL) from baseline at week 12. In patients who were not on approved antifibrotics, the median change in FVC was increased by 5.7 mL for BI 1015550 and decreased by 81.7 mL for the placebo arm; in patients who were already on antifibrotic therapy, the median change in FVC was increased by 2.7 mL for BI 1015550 and decreased by 59.2 mL for the placebo arm. It was found that BI 1015550 had a >98% probability of being superior to placebo in slowing down the worsening of lung function in people with IPF. Over 12 weeks, the trial also met its secondary goal, and the proportion of patients experiencing any adverse event (AE) was greater in patients treated with BI 1015550 compared to placebo in both AF patients (73% versus 68%) and non-AF (65% versus 52%).

Overall, the study concluded that BI 1015550 at 18 mg BID, either given alone or in combination with antifibrotic medication, preserved lung function in patients with IPF. The Company expects to initiate a phase III program for the drug later this year. The drug can be a promising oral therapeutic option for the treatment of IPF and other fibro-proliferative illnesses due to its preferential inhibition of PDE4B and anticipated enhanced tolerability in humans, as well as its anti-inflammatory and antifibrotic properties. If this drug gets approval in the upcoming years, then it will compete with already approved treatments and Boehringer Ingelheim might continue to be a leader in the IPF market.

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