Boehringer Ingelheim’s latest investigational treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis
Today, Boehringer Ingelheim announced Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine (NEJM). The promising 12-week data that showed a reduction in the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IPF) will also be presented at the American Thoracic Society (ATS) International Conference Breaking News session on May 16 in San Francisco.1
“These encouraging, early data showed that treatment with BI 1015550 slowed the rate of lung function decline in patients who were not on approved antifibrotics, as well as those who were taking existing antifibrotic therapy,” commented Luca Richeldi, Professor of Respiratory Medicine at the Università Cattolica del Sacro Cuore in Rome, Italy, and the Principal Investigator on the trial.
The primary endpoint of the trial was the change from baseline in forced vital capacity (FVC) – meaning the maximum amount of air (measured in mL) that can be forcibly exhaled from the lungs after fully inhaling – at week 12. Median changes for patients taking BI 1015550 showed a slight improvement in FVC, and in those who took placebo, FVC was reduced:1
- The median changes in FVC in patients who were not on approved antifibrotics were +5.7 mL for BI 1015550 and -81.7 mL for placebo.
- In patients already taking antifibrotic therapy, the median changes in FVC were +2.7 mL for BI 1015550 and -59.2 mL in the placebo arm.
- There is >98% probability that BI 1015550 was superior to placebo in slowing down the worsening of lung function in people with IPF.
“As the global market leader in pulmonary fibrosis, we have the ambition to go beyond slowing down disease progression and hope to one day provide a cure for this chronic debilitating condition,” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “The Phase II results reinforce our confidence in BI 1015550 which will be accelerated into a pivotal Phase III program. 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.”
The trial also met its secondary endpoint,1 demonstrating that BI 1015550 showed acceptable safety and tolerability in IPF patients over 12 weeks. Diarrhea was the most frequently reported event in all patients (>10% of patients) and all events were reported as non-serious. No new safety topics were identified, and baseline characteristics were generally balanced across both treatment groups.
BI 1015550 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in February 2022. Boehringer Ingelheim will be initiating a Phase III clinical trial program to further investigate if BI 1015550 improves lung function in people with IPF and other forms of PPF, with the ambition to bring this medicine to patients as soon as possible.
About the trial
- The Phase II randomized, double-blind, placebo-controlled study (NCT04419506) investigated the efficacy and safety of oral BI 1015550, 18 mg twice daily, in patients with IPF (n=147)
- Patients with FVC ≥45% predicted, who were either not on antifibrotic therapy or were on a stable dose of antifibrotic therapy for at least 8 weeks before study entry, were randomized 2:1 to receive either BI 1015550 18 mg twice daily or placebo for 12 weeks
- The primary endpoint was change in baseline in FVC at week 12 and the secondary endpoint was the proportion of patients with treatment-emergent adverse events during the trial
- Initiation of the Phase III program is expected later this year:
Please click on the link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/investigational-treatment-slowed-lung-function
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Media + PR
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Positive Results of EfficAPSI Real-World Study Confirm Significant Benefit of Sublingual Liquid AIT Treatment on the Onset and Worsening of Asthma in Patients With Allergic Rhinitis2.7.2022 15:08:00 CEST | Press release
Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced positive data from its EfficAPSI real-world study. Presented at the 2022 European Academy of Allergy and Clinical Immunology (EAACI) congress in Prague (Czech Republic), the real-world study confirmed significant benefit of sublingual liquid allergen immunotherapy treatment (AIT) on the onset and worsening of asthma in patients with allergic rhinitis. The retrospective longitudinal pharmaco-epidemiological real-world study included over 430,000 patients: more than 100,000 patients with allergic rhinitis with or without asthma treated with sublingual liquid immunotherapy and symptomatic drugs; compared to more than 330,000 patients with allergic rhinitis with or without asthma treated with symptomatic drugs only. The primary objective of the study was the evaluation of the impact of sublingual liquid AIT on the onset and worsening of asthma in patients with allergic rhinitis. St
Boyd Acquires Sensata’s Thermal Test and Controls Business1.7.2022 17:29:00 CEST | Press release
Boyd, a world-leading innovator of technologies in engineered materials and thermal management, announced it acquired Sensata’s Thermal Test and Controls Business (NYSE:ST). This business specializes in the design and manufacturing of advanced thermal control systems, adapters, and sockets critical to the thermal test process for high-end logic and memory semiconductors. With a long history of serving leading global semiconductor companies, the addition complements Boyd’s existing thermal business, which includes air and liquid cooled thermal management technologies. Boyd designs and manufactures complex thermal solutions for high-performance semiconductors used in applications such as 5G, hyperscale data center, eMobility, and artificial intelligence. With this acquisition, Boyd expands its offering to current semiconductor customers by adding advanced controls and thermal test systems essential to the production of high-end memory and logic devices. “This acquisition is a natural fit
IFF Completed Divestiture of Microbial Control Business1.7.2022 15:45:00 CEST | Press release
IFF (NYSE:IFF) today announced that it has successfully completed the previously announced divestiture of its Microbial Control business unit to LANXESS. Welcome to IFF At IFF (NYSE: IFF), an industry leader in food, beverage, health, biosciences and scent, science and creativity meet to create essential solutions for a better world – from global icons to unexpected innovations and experiences. With the beauty of art and the precision of science, we are an international collective of thinkers who partners with customers to bring scents, tastes, experiences, ingredients and solutions for products the world craves. Together, we will do more good for people and planet.Learn more at iff.com, Twitter, Facebook, Instagram, and LinkedIn. © 2022 by International Flavors & Fragrances Inc. IFF is a Registered Trademark. All Rights Reserved. View source version on businesswire.com: https://www.businesswire.com/news/home/20220630005790/en/Contact information Michael DeVeau Chief Investor Relations
Digi International Unveils Digi XBee LR Module for LoRaWAN Connectivity for IoT Deployments1.7.2022 15:00:00 CEST | Press release
Digi International®, (NASDAQ: DGII), a leading global provider of Internet of Things (IoT) connectivity products, solutions, and services, today unveiled the Digi XBee® LR, the first XBee-class pre-integrated and pre-certified wireless communication module for sensors and end-nodes using LoRaWAN. Coupled with the rich connectivity, device and gateway management capabilities of Digi X-ON™—its Low-Power Wide Area (LPWA) IoT data cloud platform—Digi provides a complete IoT solution with automated provisioning and deployment to help enterprises achieve significant ROI and faster market access. The Digi XBee LR module brings a new connectivity option to one of the most widely adopted wireless IoT module footprints, with more than 20 million devices deployed. This fully developed, tested, and certified module gives OEMs the freedom to create innovative public- or private-cloud solutions for organizations in agriculture, energy, logistics, manufacturing, utilities, and other sectors. These ap
Juniper Networks Announces Cloud Metro Innovation to Drive Sustainable Business Growth for Service Providers1.7.2022 14:35:00 CEST | Press release
Juniper Networks (NYSE: JNPR), a leader in secure, AI-driven networks, today announced the innovation that will power its vision and strategy for Cloud Metro – a new category of solutions for service providers, optimized for metro transformation and sustainable business growth. Traditional “retro” metro networks are device-centric and are buckling under the extreme scale, agility and experience demands that widespread digital transformation and the advent of 5G services are bringing. Today’s announcement focuses on enabling sustainable business growth, with a series of high-performance networking systems, powered by AI-enabled, cloud-delivered automation, specifically designed to build next generation Cloud Metro infrastructure. These systems will deliver significantly-reduced natural resource consumption capabilities to help sustain the planet, improved tools and simplified working methods to help sustain over-pressured operations teams, along with embedded service assurance and secur
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom