Amlitelimab

iStock, BeritK Since stepping in as Sanofi’s CEO in April, Belén Garijo has launched a deep look at the pharma’s pipeline, reassessing assets based on “scientific merit” and potential for long-term value in the quest for a Dupixent follow-up. Sanofi has suspended a Phase 2 study testing an investigational antibody in non-cystic fibrosis bronchiectasis, as new CEO Belén Garijo reassesses the company’s pipeline. The pause was driven by “strategic business reasons to facilitate internal portfolio review,” and not because of the asset’s safety or benefit/risk profile, according to a federal clinical trials database . The asset in question is called SAR445399, a monoclonal antibody designed to block the interleukin-1 receptor 3 (IL-1R3), a key player in immune-related signaling cascades. The drug came to Sanofi in December 2015 when the pharma inked a research and license collaboration with MAB Discovery. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Sanofi’s pipeline page lists SAR445399 as under mid-stage development for hidradenitis suppurativa. That study remains open and recruiting as of July 1. Sanofi has no pipeline entry for the asset in non-cystic fibrosis bronchiectasis. BioSpace has reached out to the pharma for more color on the matter. Sanofi is amid what Garijo calls a “very rigorous portfolio prioritization process.” Garijo, who took the reins in April succeeding former chief executive Paul Hudson , revealed this effort during the company’s second quarter earnings call last week, noting that “we are going to look very deeply at our current late-stage portfolio.” The decision to push an asset forward, she said, will depend on “scientific merit, potential to create long-term value and, obviously, ensuring the right risk pro our pipeline moving forward.” Earnings Sanofi’s new CEO wants more ‘realistic view’ of Phase 3 go/no-go decisions Sanofi is going to “look very deeply” at its late-stage pipeline as part of a portfolio prioritization initiative, though new CEO Belén Garijo didn’t commit to shelving a specific number of assets. July 30, 2026 · 2 min read · Tristan Manalac Read more That same day, Sanofi revealed that it would shelve the IL-33 inhibitor itepekimab, which was being developed for chronic obstructive pulmonary disease. Phase 3 data released in May last year were mixed: itepekimab significantly reduced exacerbations in former smokers with inadequately controlled disease in only one of two late-stage trials. Sanofi had been positioning itepekimab as a successor to its blockbuster drug Dupixent, which will lose key patent protections in the coming years . Sanofi also axed the oral TNFR blocker balinatunfib last week, after the asset failed to significantly ease psoriasis severity in a mid-stage study. Late last month, the pharma also discontinued all but one of its ongoing studies for the investigational antibody amlitelimab after a disappointing showing in a Phase 3 atopic dermatitis trial. Sanofi has also scrapped plans to amlitelimab’s approval, which the company had originally scheduled for later this year. Only a celiac disease study of amlitelimab will stay online, with data expected later this year. Sanofi obtained amlitelimab in its $1.4 billion acquisition of Kymab in 2021. In conjunction with the trial discontinuations, the pharma absorbed a €952 million ($1.1 billion) impairment loss in the second quarter. Drug Development Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations. July 24, 2026 · 3 min read · Gabrielle Masson Read more

Sanofi halted a phase 2 trial testing a monoclonal antibody, SAR445399, in non-cystic fibrosis bronchiectasis, Fierce Biotech has learned. The trial , which began only back in April, was a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score following treatment with SAR445399 compared with placebo in adults aged 18 to 80 years with NCFB, a chronic lung disease. The trial was officially reported as halted on July 29, the day before Sanofi’s second-quarter earnings call. The decision to pause the trial was made “as part of a company-wide portfolio review for strategic business reasons,” and not due to safety concerns, a Sanofi spokesperson told Fierce. The move to pause the NCFB trial comes during a trying time for Sanofi following a year filled with a series of trial fails . In February, the French pharma ousted CEO Paul Hudson and appointed Merck KGaA leader Belén Garijo, M.D., Ph.D., to steer the ship. Since then, Garijo has been doing a deep dive on correcting the company’s strewn R&D and clinical strategies. On July 24, Sanofi scrapped amlitelimab for atopic dermatitis, despite its lore as being a potential $5 billion blockbuster. During its second-quarter report, the company abandoned two more assets, balinatunfib and itepekimab, following failed trial results in psoriasis and chronic obstructive pulmonary disease , respectively. SAR445399 , only first revealed by Sanofi in 2023, is an anti-interleukin-1 receptor 3 monoclonal antibody developed to block the interleukin 1, 33, and 36 cytokine pathways. These pathways can be important in chronic immune-related dermatologic diseases, such as atopic dermatitis and hidradenitis suppurativa, as well as respiratory conditions, such as NCFB. NCFB affects roughly half a million people in the U.S., with a global incidence of greater than one million cases. In August 2025, Insmed received FDA approval for Brinsupri , a DPP1 inhibitor targeting neutrophil activation, for treatment of NCFB in adults and kids ages 12 and older. The British biotech Infex Therapeutics showed promising NCFB phase 2a data using their monoclonal antibody, INFEX702 , which acts by disabling Pseudomonas aeruginosa, a bacteria known to be a major pathogen of NCFB. Sanofi is currently running a separate phase 2 study testing SAR445399 as a potential treatment for the inflammatory skin condition hidradenitis suppurativa.