Sanofi has suspended a Phase 2 study evaluating an investigational antibody for non-cystic fibrosis bronchiectasis, as new CEO Belén Garijo undertakes a reassessment of the company's drug development portfolio, according to an Aug. 6 announcement.
The company said the pause was due to “strategic business reasons to facilitate internal portfolio review,” and not because of any concerns about the asset’s safety or benefit/risk profile, as reported in a federal clinical trials database. The antibody in question, SAR445399, is designed to block the interleukin-1 receptor 3 (IL-1R3), which plays a role in immune-related signaling pathways. Sanofi acquired rights to this drug through a research and license agreement with MAB Discovery in December 2015.
According to Sanofi’s pipeline page, SAR445399 remains under mid-stage development for hidradenitis suppurativa and that study continues recruiting participants as of July 1. There is no listing for its use in non-cystic fibrosis bronchiectasis on the company’s pipeline overview. BioSpace has contacted Sanofi for further details regarding the decision.
Garijo described her approach as a “very rigorous portfolio prioritization process.” She took over leadership from former chief executive Paul Hudson in April and discussed this strategy during Sanofi’s second quarter earnings call last week. “We are going to look very deeply at our current late-stage portfolio,” Garijo said during the call. She added that decisions about advancing assets will be based on “scientific merit, potential to create long-term value and, obviously, ensuring the right risk profile of our pipeline moving forward.”
On July 30, Sanofi also announced it would discontinue development of itepekimab—an IL-33 inhibitor previously targeted at chronic obstructive pulmonary disease—after mixed results from two late-stage trials released last year. The company had positioned itepekimab as a potential successor to Dupixent ahead of upcoming patent expirations.
In addition, Sanofi recently ended development of other assets including balinatunfib after it failed a mid-stage psoriasis trial and discontinued all but one ongoing study for amlitelimab following disappointing results in atopic dermatitis. Only amlitelimab's celiac disease trial will continue, with data expected later this year.
