Boehringer Ingelheim Initiates Phase 2 Trial for Novel IPF Treatment

A new clinical trial (NCT07036523) evaluating a novel monoclonal antibody to treat patients with idiopathic pulmonary fibrosis (IPF), conducted by Boehringer-Ingelheim, a biopharmaceutical company and investor in research and development, began recruiting participants in Germany.1,2 The drug BI 765423 signifies another step forward in Boehringer-Ingelheim’s goal to advance innovative care for those living with IPF.1 Despite numerous standard therapies that may help slow the progression of the disease, there still remains an unmet need to stop disease progression and reverse lung tissue damage completely. Prior research and ongoing clinical trials suggest a potential breakthrough in stopping the progression of the disease with experimental, targeted, oral therapies.3 BI 765423 targets pleiotropic cytokine IL-11 inhibition—a key biomarker and mediator of fibrosis.1 “With BI 765423, we aim to go beyond slowing disease and to pursue next-generation therapies that could restore lung functionality for people living with IPF,” Vittoria Zinzalla, global head of Experimental Medicine at Boehringer Ingelheim, said in a press release. BI 765423 is designed to bind directly to IL-11, thus interrupting the signaling pathways that cause fibrosis. Prior preclinical studies have shown that inhibiting IL-11 can halt fibrosis and restore barrier function.1 Another phase 2a clinical trial demonstrated reduced type 2 (IL-4 and IL-13) and type 3-associated cytokines (IL-17a and IL-22) when targeting invariant natural killer T cells (iNKT) in patients with IPF. Thus, supporting Boehringer-Ingelheim’s objective to target profibrotic cytokines, which may reduce fibrosis and lung tissue damage in patients with IPF while restoring lung functionality. In phase 1 of the biopharmaceutical company’s clinical trial, BI 765432 demonstrated favorable safety and tolerability in participants. Phase 2 of the clinical trial aims to evaluate the efficacy of the drug. The double-blind, randomized, placebo-controlled, parallel-group study is open to adults with IPF aged 40 or older of either sex. Participants must have a forced vital capacity greater than or equal to 45% and fibrosis of 20% or more confirmed by a high-resolution computed tomography. Patients must also have a hemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of 20% or greater. Participants will be randomized 1:1 to receive BI-765432 or a placebo, administered intravenously every 4 weeks for 8-10 months. During the study, participants can continue their regular treatment for IPF and frequently visit the study site for screenings, treatment, and follow-up.2 Some of the outcomes expected to be measured include absolute change in FVC, DLCO, oxygen saturation, distance walked during a 6-minute walk test, and log10-transformed SPD plasma concentration from baseline to 12 weeks. There are currently 71 participants enrolled in the clinical trial. The study is expected to be completed in September 2027. Of the 50 study locations, 6 sites have begun recruiting participants: Chesterfield, Missouri; Franklin, Tennessee; Chermside, Queensland, Australia; Hanover, Germany; Fukuim Yoshida-gun, Japan; and Busan, South Korea. Although Boehringer Ingelheim is evaluating the safety and efficacy of BI 765423, the company acquired the drug from Enleofen to continue its development and maintain control. The drug’s intellectual property—including patents, data, and know-how—was in-licensed by Enleofen from Singapore Health Services and the National University of Singapore.1 “Our aim is to transform the lives of patients and their families by demonstrating the potential of this first-in-class IL-11 inhibitor to deliver clear benefits for patients, backed by compelling evidence and delivered at speed,” Zinzalla said. References: 1. Boehringer Ingelheim advances potential first-in-class IL-11 inhibitor to phase II clinical research in idiopathic pulmonary fibrosis. News release. Boehringer-Ingelheim. January 13, 2026. Accessed January 20, 2026. https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/new-trial-explores-advancements-ipf-treatment 2. A study to find out whether BI 765423 has an effect on lung function in people with idiopathic pulmonary fibrosis (IPF) with or without standard treatment. Clinicaltrials.gov. January 6, 2026. Accessed January 20, 2026. https://clinicaltrials.gov/study/NCT07036523?a=11#contacts-and-locations 3. McCrear S. Phase 2a trial shows Gri-0621 improves biomarkers and lung repair in IPF. AJMC. January 20, 2026. Accessed January 20, 2026. https://www.ajmc.com/view/phase-2a-trial-shows-gri-0621-improves-biomarkers-and-lung-repair-in-ipf