Insmed has discontinued development of its drug Brinsupri in hidradenitis suppurativa (HS), marking the second clinical setback for the therapy in four months and narrowing its expansion potential beyond its initial approval.
A Phase 2b trial evaluating Brinsupri in adults with moderate-to-severe HS failed to meet both primary and secondary endpoints across the 10 mg and 40 mg once-daily dosing arms. As a result, the company has decided to terminate development in this indication.
The decision follows a similar outcome in another mid-stage study targeting chronic rhinosinusitis without nasal polyps (CRSsNP), where the first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor also failed to demonstrate efficacy. With both dose groups missing all endpoints, Insmed has now abandoned development in that indication as well.
Efficacy Challenges Underscore HS Trial Complexity
In the HS study, which enrolled 214 patients, Brinsupri did not outperform placebo. Patients receiving the 10 mg and 40 mg doses achieved reductions in total abscess and inflammatory nodule (AN) counts of 46% and 40%, respectively—compared to a 57% reduction in the placebo group.
HS is a chronic inflammatory skin disease characterized by painful nodules, abscesses, and scarring, often occurring in areas rich in sweat glands. The condition remains particularly challenging for drug development, partly due to high placebo response rates and limited predictive preclinical models.
Treatment-emergent adverse events (TEAEs) were more frequent in the 10 mg group (55%) compared to the 40 mg (43%) and placebo (46%) arms. Serious TEAEs were reported in three patients in the 10 mg cohort, versus one case each in the 40 mg and placebo groups.
Analysts See Limited Impact Despite Pipeline Setbacks
According to Insmed’s Chief Medical Officer, Martina Flammer, the lack of established animal models in HS continues to complicate clinical development. Despite the disappointing outcome, she noted that insights from the trial may contribute to broader scientific understanding of the disease.
Analysts were largely unsurprised by the results. Mizuho Securities described a “silver lining” in Brinsupri’s favorable safety and tolerability profile, while Matt Phipps of William Blair highlighted the inherent difficulties of HS trials, including high placebo response rates and limited supporting preclinical evidence for DPP1 inhibition.
Phipps noted that expectations for the HS readout were already low, resulting in minimal impact on Insmed’s valuation. Shares rose modestly—by approximately 1%—ahead of U.S. market open following the announcement.
Commercial Outlook Narrows
While Brinsupri remains approved for bronchiectasis, its commercial outlook has tightened following the recent clinical failures. After the CRSsNP setback disclosed in December, Mizuho analysts revised peak annual sales estimates downward from $16 billion to $11 billion, reflecting the loss of a large potential patient population.
Despite these challenges, early commercial performance has been strong. Insmed reported $173 million in Brinsupri sales last year, just months after launch, with first-quarter revenues projected to reach $198 million, according to Visible Alpha.
What Happened in the Latest Trial
The recent trial results revealed that Insmed’s Brinsupri failed to meet key endpoints, mirroring earlier setbacks. This repeated outcome has led Insmed to reconsider further investment in the drug’s development at this stage.
For Insmed, the inability of Brinsupri to deliver consistent mid-stage success raises questions about its efficacy and overall viability in competitive therapeutic markets.
Impact on Insmed’s Pipeline Strategy
The halt in Brinsupri expansion forces Insmed to shift focus toward other pipeline assets. While Insmed continues to maintain a strong presence in rare disease treatments, this setback highlights the inherent risks in drug development.
Investors are closely watching how Insmed reallocates resources and whether the company will prioritize alternative programs with stronger clinical data.
The decision by Insmed to halt Brinsupri expansion underscores the uncertainty of clinical development. While the setback is significant, Insmed still has opportunities to pivot and strengthen its broader pipeline strategy.
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