fiercebiotechNovember 03, 2017
Tag: Sanofi , IL-4/IL-13 , lung-scarring
In Sanofi’s third-quarter results posted early this morning, the French Big Pharma says it is canning a phase 2 trial in idiopathic pulmonary fibrosis (IPF), following poor results from Roche and AstraZeneca.
Buried amid its financials, Sanofi revealed simply that it has "decided to stop the development of SAR156597 in idiopathic pulmonary fibrosis," which had been in phase 2.
The drug had seen the study completed and top-line data were expected to be known in mid-August, according to clinicaltrials.gov. The primary endpoint had been absolute change from baseline in percent predicted forced vital capacity at one year.
The bispecific IL-4/IL-13 antibody appears to have followed Roche and its failed attempt with its IL-13 drug lebrikizumab in asthma, which it discontinued after mixed results.
RELATED: Double disappointment for AstraZeneca lung drug tralokinumab
Just this week, AstraZeneca also saw its IL-13 mAb flop in two late-stage tests, STRATOS 2 and TROPOS, when it failed to beat out placebo and decrease the need for steroids, respectively, and came after another failed pivotal trial earlier in the year. AZ had already ditched work for its medication in IPF last year. It appears Sanofi couldn’t make it work either.
But SAR156597 still lives on in an early-stage placebo-controlled study in the autoimmune disease diffuse systemic sclerosis, with Sanofi set to see how it’s working next October.
In systemic sclerosis, the body’s immune system attacks the internal organs and a patient’s skin. This type mostly affects women and usually develops between 30 and 50 years of age.
But despite this cutback, and it stopping work on a Zika vaccine, Sanofi’s R&D bill jumped, with expenses booking a 12.9% CER increase to €1.34 billion ($1.56 billion) in the third quarter.
The boost comes amid increased spending on the development programs in immuno-oncology and diabetes drug sotagliflozin, as well as a "low base for comparison" for the third quarter last year, the pharma said.
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