Sanofi suspends chronic lung disease phase 2 study, tied to ‘strategic business reasons’
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. Related Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues 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.
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.
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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.
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