Insmed Incorporated (NASDAQ:INSM) saw its shares retreat roughly 2% in after-hours trading on Tuesday after the company disclosed it will discontinue its hidradenitis suppurativa (HS) development program following disappointing Phase 2b results.
The CEDAR study evaluated brensocatib in adult patients with moderate to severe HS. According to Insmed, the trial did not achieve either its primary or secondary efficacy endpoints for the two dosing regimens tested - brensocatib 10 mg and brensocatib 40 mg - and the company said it will cease development of the drug for this indication.
At the 16-week assessment, participants assigned to brensocatib 10 mg experienced a 45.5% reduction from baseline in total abscess and inflammatory nodule count, while those on the 40 mg dose saw a 40.3% reduction. The placebo group, by contrast, registered a 57.1% reduction, a greater improvement than either active-treatment arm.
Insmed reported that brensocatib was generally well tolerated in the trial and that no new safety signals emerged, including at the 40 mg dose, which the company notes is the highest dose it has studied to date. During the 16-week placebo-controlled period, treatment-emergent adverse events were reported in 55.4% of patients in the 10 mg arm and 42.9% in the 40 mg arm, compared with 45.7% in the placebo arm.
The CEDAR trial was a randomized, double-blind, placebo-controlled Phase 2b study enrolling 214 patients across 72 sites globally. Participants were randomized to receive once-daily dosing of either brensocatib 10 mg, brensocatib 40 mg, or placebo for 16 weeks.
Insmed said it plans to present the CEDAR data at a future medical congress. The company also highlighted a development challenge specific to HS - a lack of established animal models - that it believes complicates clinical progress in this disease area.
Investors reacted modestly to the announcement in after-hours trading. The company’s decision to discontinue the HS program followed the trial’s failure to demonstrate efficacy over placebo in the measured endpoints.