Regeneron, Sanofi rack up a PhIII asthma win for dupilumab; Verastem preps FDA app for duvelisib
→ Regeneron and Sanofi say their trial of Dupixent (dupilumab) hit the primary and key secondary endpoints in a Phase III asthma study. Their drug reduced the use of steroids by 70%, compared to 42% for the placebo arm. “Importantly, despite a reduction in oral corticosteroid use, dupilumab was associated with an improvement in lung function. This is the third study in which dupilumab has demonstrated a reduction in asthma attacks and improvement in lung function in a broad group of patients with uncontrolled asthma – this effect was most profound in patients with elevated markers of Type 2 allergic inflammation, such as an eosinophil count over 300,” said Regeneron chief scientist George Yancopoulos.
→ A year after liver toxicity was seen in a pair of patients in its pivotal study of pexidartinib, Daiichi Sankyo and its subsidiary Plexxikon say the trial hit the primary endpoint on tumor reduction in the Phase III. At the time enrollment was halted, researchers were just 5 short of their 126-patient goal, allowing them to wrap the study. All we have right now, though, is a brief top-line statement on efficacy, with no details on the data or the safety profile. The drug was tested in patients with symptomatic tenosynovial giant cell tumors.
→ Verastem $VSTM says it’s ready to take duvelisib to the FDA in search of an approval. The biotech — which reported out positive progression-free survival data while holding back the results on other endpoints — will set out to get a green light to market the therapy for drug-resistant chronic lymphocytic leukemia/small lymphocytic lymphoma, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma. Verastem got the drug from Infinity, which gave it up for nothing down after producing disappointing data that persuaded AbbVie to dump its partnership.
→ San Diego-based Arcturus Therapeutics is teaming up with Craig Venter’s Synthetic Genomics to develop RNA-based vaccines and therapeutics in both human and animal health. The marriage of Arcturus’ delivery tech with Synthetic Genomics’ RNA replicon platform, they say, could lead to cheaper and more efficacious drugs.