BOEHRINGER-INGELHEIM
9.5.2023 14:36:33 CEST | Business Wire | Press release
Boehringer Ingelheim announced today that it has launched clinical development of its first-in-class IL-11 inhibitor antibody BI 765423 with a Phase 1 study (NCT05658107) to assess the safety, tolerability, and pharmacokinetics in healthy volunteers. Boehringer Ingelheim is already a global leader in the treatment of pulmonary fibrosis, and the initiation of clinical development of the anti-IL-11 treatment reflects the company’s long-term commitment to combat fibrotic disease across therapeutic areas. The IL-11 inhibitor antibody is the first of its kind to reach clinical development stage and is based on a partnership between the Company and Enleofen Bio Pte. Ltd. (Enleofen), with a goal to improve patient outcomes.
‘Fibrotic disease’ is a term that covers a range of diseases characterized by uncontrolled and progressive fibrosis, or scarring, of various organs and tissues. It can be triggered by different factors (such as infections, inflammation, autoimmune disorders, degenerative diseases, tumors, and injury), can cause organ dysfunction/failure, and affect the quality of life and survival of patients. Some examples of fibrotic diseases are, systemic sclerosis, graft-versus-host disease as well as heart, lung, liver, and kidney fibrosis. Current treatments have led to progress in some areas, however fibrotic diseases remain to be a leading cause of morbidity/mortality and account for more than one third of deaths worldwide.
IL-11 plays a key role in fibrosis across multiple organs and pre-clinical studies have shown that anti-IL-11 treatment has the potential to stop – and even reverse fibrosis – in different fibrotic diseases. Boehringer Ingelheim joined forces with Enleofen, a leader in IL-11 biology, in 2020.
“The initiation of this trial is an important milestone for Boehringer Ingelheim and brings us closer to achieving our aim of transforming lives of people living with fibrotic diseases,” said Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. “The effects shown for anti-IL-11 preclinically are impressive and could, if confirmed in the clinic, herald a dramatic advance in the treatment of fibrotic diseases.”
“Enleofen is very excited to see the IL-11 inhibitor partnership with Boehringer Ingelheim, a leader in anti-fibrotic therapy R&D, moving forward into the clinic to address unmet patient needs,” said Prof Stuart Cook, co-founder of Enleofen and Tanoto Foundation Professor of Cardiovascular Medicine at the SingHealth Duke-NUS Academic Medical Centre and the Cardiovascular & Metabolic Disorders Programme at Duke-NUS Medical School, Singapore.
The IL-11 program complements Boehringer Ingelheim’s clinical fibrotic disease pipeline portfolio which includes BI 1015550, a phosphodiesterase 4B (PDE4B) inhibitor, under investigation in two Phase III randomized, double-blind, placebo-controlled trials—FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082)—to investigate the efficacy, safety and tolerability of BI 1015550 over at least 52 weeks in patients with IPF and in patients with other progressive fibrosing ILDs and several other clinical stage programs.
###
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com
About Enleofen
Enleofen is a Singapore-based biotech company developing first-in-class antibody therapeutics for the treatment of fibro-inflammatory human diseases. The initial discovery science and drug target validation was carried out by founders Stuart Cook and Sebastian Schäfer at the National Heart Centre Singapore at SingHealth and Duke-NUS Medical School and was subsequently licensed to Enleofen. Since 2017, the company has invested extensively in target validation, drug development, and preclinical studies, with the support of experienced international life sciences executives and investors, including founding directors Jeffrey Lu and Andrew Khoo.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230509005762/en/
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
Doubtless Pet Care Launches to Provide Peace of Mind to Pet Parents and Help Their Pets Live Happier, Healthier Lives29.6.2026 10:15:00 CEST | Press release
Doubtless combines industry-leading pet insurance with innovative care solutions, protecting more than 6 million pets across 10 global markets Doubtless launches today with the goal of helping more pet parents across the world access quality care for the pets they love. The company brings together a leading global portfolio of pet insurance brands with a growing range of connected solutions designed to support pet parents at every stage of their pet’s life. With over 4,000 employees, Doubtless insures 6 million pets across 10 markets in North America, Europe and the United Kingdom. “Uncertainty about the financial commitments associated with having a pet should never keep families from experiencing the joy of a life with pets,” said Dirk Beeckman, CEO of Doubtless. “By harnessing the power of our international footprint, we are building on our leadership in pet insurance to create a global suite of solutions for pet parents, veterinarians and industry partners that makes pet care easie
Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)29.6.2026 09:19:00 CEST | Press release
Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda; Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24Phase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints. “We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. “We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patie
IQM Named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment29.6.2026 09:00:00 CEST | Press release
IQM today announced it has been named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629748732/en/ IQM named a major player in the IDC MarketScape IQM believes this recognition comes as institutions worldwide move quantum computing out of shared cloud access and into infrastructure they own and operate themselves. IQM calls this Production Quantum: full-stack, open-architecture superconducting systems deployed on premises, inside customers' own data centers and HPC environments, where organizations own the hardware, build internal expertise, and run quantum processors alongside their existing classical infrastructure. According to the IDC MarketScape, "For institutions building long-term quantum programs, this means the workflows and intellectual property developed on IQM hardware remain portable." The report further advises: "Consi
Zambon Announces Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations29.6.2026 09:00:00 CEST | Press release
Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more “Good ON” time with fewer daily doses compared with immediate-release levodopa/carbidopa More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026 Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European M
Enhertu® Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors29.6.2026 08:30:00 CEST | Press release
Approval based on three phase 2 trials of Daiichi Sankyo and AstraZeneca’s Enhertu that demonstrated clinically meaningful responses across a broad range of tumors Enhertu now approved for six indications in the EU Enhertu® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across thr
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