Sanofi has reported setbacks to a trio of candidates bought in by its business development team, halting (PDF) work or posting negative data on assets picked up from Denali Therapeutics, Kymab and Principia Biopharma.
The actions affect two midphase candidates—although, in both those cases, work will continue in other indications—and one phase 1 asset. One of the phase 2 candidates is eclitasertib, a RIPK1 inhibitor that Sanofi secured from Denali in 2018 as part of an agreement worth $125 million upfront. The deal gave Sanofi rights to two RIPK1 inhibitors, one for neurodegeneration and one for inflammatory diseases.
Eclitasertib is the inflammatory disease candidate. Brushing off a failed attempt to establish the molecule in COVID-19, Sanofi moved the drug into a phase 2 trial in cutaneous lupus erythematosus in 2021. Efficacy data from the trial have persuaded the French pharma to pull out of the indication but to continue to study eclitasertib in ulcerative colitis. The primary completion date for the ulcerative colitis trial is 2025.
The setback is a blow for the Denali collaboration, but work on the neurodegeneration asset is ongoing. Sanofi and Denali switched from the original neurodegeneration candidate early in the collaboration but have made progress since then, launching phase 2 trials in amyotrophic lateral sclerosis and multiple sclerosis.
Sanofi also shared a mixed update on rilzabrutinib, one of the BTK inhibitors it acquired in its $3.7 billion takeover of Principia. The candidate, which flunked a phase 3 trial in a rare autoimmune skin disease two years ago, recently hit in chronic spontaneous urticaria (CSU) but missed in atopic dermatitis. Sanofi included updates on the two phase 2 trials in its financial results Friday.
In CSU, Sanofi linked rilzabrutinib to improvements in itch severity, causing the trial to hit its primary endpoint. However, the candidate failed to meet the eczema area and severity endpoint in the atopic dermatitis trial. Sanofi noted “numerical improvements were seen in other important clinical components” of atopic dermatitis and is yet to discuss next steps in either indication. A phase 2 asthma trial is ongoing, the company pointed out.
Sanofi’s bet on Kymab’s atopic dermatitis drug candidate has fared better so far, with a phase 2 clinical trial of the anti-OX40-ligand monoclonal antibody hitting its primary endpoint earlier this year. But the drugmaker reported a blow to another asset acquired in the $1.1 billion Kymab takeover, revealing it stopped a phase 1 solid tumor trial of the anti-ICOS antibody alomfilimab. The action was unrelated to safety.
The French pharma plans to throw more money behind its remaining candidates, telling investors that it will use savings made through “strategic cost initiatives” to fund “innovation and growth drivers.” As part of this strategy, Sanofi confirmed that it will spin out its consumer health business, potentially as soon as next year.