Boehringer Ingelheim has reported data from a Phase II clinical trial where its new investigational therapy, BI 1015550, showed a cut down in the rate of decline in lung function in patients with idiopathic pulmonary fibrosis (IPF).
BI 1015550 is an inhibitor of phosphodiesterase 4B (PDE4B).
The randomised, placebo-controlled, double-blind trial analysed the safety and efficacy of twice-a-day 18mg oral dose of BI 1015550 in 147 subjects with IPF.
Participants were categorised into a 2:1 ratio to receive either BI 1015550 or a placebo for 12 weeks.
The study included patients with FVC ≥45% predicted, who were receiving a stable dosage of antifibrotic treatment for a minimum of eight weeks before entering the trial or did not receive such treatment.
Variation from baseline in forced vital capacity (FVC) at week 12 was the trial’s primary endpoint.
The secondary endpoint was the proportion of subjects with treatment-emergent adverse events during the study.
In subjects who did not receive antifibrotics, the median changes in FVC were +5.7 mL and -81.7 mL in the BI 1015550 treatment and placebo arms, respectively.
The median changes in FVC in patients who were receiving antifibrotic treatment were +2.7 mL and -59.2 mL for BI 1015550 and placebo, respectively.
Furthermore, the company noted that BI 1015550 had more than 98% probability of being superior versus placebo in reducing the lung function decline in IPF patients.
The trial also met the secondary endpoint with BI 1015550 found to possess acceptable safety and tolerability in trial subjects over 12 weeks.
The most commonly reported event in trial subjects was diarrhoea without any new safety signals detected.
Boehringer Ingelheim Human Pharma head and managing directors board member Carinne Brouillon said: “The Phase II results reinforce our confidence in BI 1015550 which will be accelerated into a pivotal Phase III programme.
“We will work with regulatory agencies and scientific communities to potentially bring the next generation of treatments to people living with pulmonary fibrosis as quickly as possible.”
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