Insmed announced on Apr. 8 that it will stop developing its lung disease drug Brinsupri for the treatment of hidradenitis suppurativa, a chronic skin condition, following disappointing results from a mid-stage clinical trial.
The decision comes after data from the Phase 2b CEDAR study showed no sign of efficacy for Brinsupri in treating hidradenitis suppurativa. This outcome may open opportunities for other pharmaceutical companies to advance their own treatments for the condition.
According to analysts at William Blair, "the placebo arm outperformed both Brinsupri doses that Insmed studied." At 16 weeks, patients receiving Brinsupri experienced a reduction in abscess and inflammatory nodule count by 45.5% and 40.3% for the 10-mg and 40-mg doses respectively, while those on placebo saw a greater reduction of 57.1%. The study also missed its secondary endpoints, though specific details were not provided by Insmed.
Other companies have reported progress in this area recently. Incyte’s JAK1 inhibitor povorcitinib maintained significant clinical benefit through more than a year of follow-up in two late-stage studies presented at an American Academy of Dermatology meeting. UCB’s Bimzelx sustained symptom improvements over three years and received Food and Drug Administration approval for hidradenitis suppurativa in November last year. Novartis expanded Cosentyx's approved use to include pediatric patients aged twelve and up after securing FDA approval as the first new biologic treatment for this skin disease in nearly ten years.
Analysts at Guggenheim Partners said, “We are not surprised by the negative results,” citing only a ten percent probability of success assigned to the CEDAR study due to "the company’s own low expectations" as well as "the lack of established animal models" and "the absence of compelling pre-clinical data" supporting Brinsupri's mechanism in this indication. William Blair analysts also referenced previous failures with Brinsupri—including another mid-stage trial where placebo outperformed active doses—in chronic rhinosinusitis without nasal polyps.
Brinsupri is an oral DPP1 inhibitor approved since August last year as the first treatment for non-cystic fibrosis bronchiectasis—a rare lung disorder—and was described by William Blair as achieving a “blowout sales performance” with $144.6 million reported in fourth-quarter sales.
