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BI 1015550 is a novel phosphodiesterase 4B (PDE4B) inhibit.
Ingelheim, Germany, May 16, 2022 /PRNewswire/ -- Boehringer Ingelheim published Phase 2 data for BI 1015550 in the New England Journal of Medicine (NEJM) on May 15, 202 BI 1015550 is a novel phosphodiesterase 4B (PDE4B) inhibitor whose 12-week clinical trial data showed great potential to delay the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IP.
"These encouraging early data suggest that treatment with BI 1015550 can delay anti-fibrotic drug-naïve as well as current anti-fibrotic drug recipients," said Luca Richeldi, principal investigator of the trial and professor of Respiratory Medicine at the Catholic University of the Sacred Heart in Ita.
The primary endpoint of the trial was the change from baseline in forced vital capacity FVC (the maximum amount of air that can be forcedly exhaled from the lungs after a complete inspiration, in milliliters) at week 1 The median change in FVC showed a slight improvement in patients taking BI 1015550, while there was a decrease in FVC in patients taking placebo1:
Among patients not taking approved anti-fibrotic drugs, patients taking BI 1015550 had a median increase in FVC of 7 mL, while those taking placebo had a median decrease in FVC of 87 .
"As the global market leader in the treatment of pulmonary fibrosis, we are not only interested in slowing disease progression, but also hope to one day cure this chronic progressive disease," said Carinne, Member of the Executive Board of Boehringer Ingelheim and Head of the Human Medicines busine.
The trial also met secondary endpoints, demonstrating that BI 1015550 demonstrated acceptable safety and tolerability in IPF patients over 12 wee.
BI 1015550 was granted Breakthrough Therapy Designation by the.
About the test
Phase II randomized, double-blind, placebo-controlled trial (NCT04419506) to investigate the efficacy and safety of oral BI 1015550 (18 mg twice daily) in patients with IPF (n=147) Patients requiring FVC as a percentage of predicted ≥45%, and meet the conditions of no or stable dose of anti-fibrotic therapy for at least 8 weeks prior to study entry, randomized 2:1 to receive BI 1015550 18 mg twice daily or placebo during the trial, The 12-week primary endpoint is change from baseline in FVC at Week 12, and the secondary endpoint is the proportion of patients experiencing adverse reactions during the trial Phase III program is expected to start later this year: NCT05321082: Progressive Fibrotic Interstitial Lung Disease (PF-ILD) Patient NCT05321069: Idiopathic Pulmonary Fibrosis Patient
About IPF
Idiopathic pulmonary fibrosis (IPF) is the more common type of progressive fibrotic interstitial lung diseaseSymptoms of IPF include dyspnea with activity, persistent dry cough, chest tightness, fatigue, and weakness Although considered a "rare" disease, there are approximately 3 million people with IPF worldwide4, The disease mainly involves patients over the age of 50, with more men than women
Interstitial lung diseases include more than 200 lung diseases that can lead to pulmonary fibrosisPulmonary fibrosis refers to irreversible scarring of lung tissue that negatively affects lung function and quality of life, and can be life-threateni.
references
Richeldi.
Pulmonary Fibrosis Types and Caus.
Sympto.
Nalysnyk.
Data on fi.
Other Types of Pulmonary Fibros.
Source: Boehringer Ingelheim
