Insmed is putting a stop to the development of Brinsupri (brensocatib) in hidradenitis suppurativa (HS) after the drug failed to meet its efficacy endpoints in a mid-stage trial.
This follows the results of the Phase IIb CEDAR study (NCT06685835), which revealed that neither a 10mg nor a 40mg dose of Brinsupri bested the baseline reduction in total abscess and inflammatory nodules versus placebo.
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During the trial, patients given a low or high daily dose of the dipeptidyl peptidase 1 (DDP1) blocker saw a 45.5% and 40.3% drop in abscess and nodule counts from baseline, while the placebo group experienced a 57.1% reduction, missing the trial’s primary endpoint.
The drug also failed to meet the secondary endpoints, which included measures of clinical response, number of flares, symptomatic severity and quality of life (QoL) measures. Insmed is yet to share data from these elements of the trial, though the company does plan to disclose details at an upcoming medical conference.
Patients generally tolerated Brinsupri well in this trial, with one and three individuals (1.4%, 4.1%) experiencing a severe or serious treatment-emergent adverse event (TEAE) in the 10mg group. Further details on these events remain undisclosed.
Brinsupri label expansion ploys thwarted
The results of this study will be disappointing for Insmed, which also previously failed to expand Brinsupri’s reach into chronic rhinosinusitis without nasal polyps (CRSsNP) back in December 2025 after the drug came up short in a Phase II trial.
The New Jersey biopharma originally identified the DPP1 blocker’s potential to treat HS due to the involvement of neutrophils in this disease, which Brinsupri targets through the inhibition of neutrophil serine proteases that drive inflammation.
However, Jefferies analysts were not particularly surprised by the CEDAR trial miss. This is because the drug previously failed in CRSsNP, and they believe there was a slim rationale for the drug’s mechanism of action in HS.
Analysts at William Blair held similar sentiments, noting there was a lack of preclinical evidence to support DPP1 inhibition in HS.
Insmed originally secured approval for Brinsupri in August 2025, making it the first medicine to get the regulatory greenlight as a treatment for non-cystic fibrosis bronchiectasis. According to an analyst consensus forecast from GlobalData, the parent company of Clinical Trials Arena, Brinsupri will become a blockbuster seller in 2027, while it will bring in $5.5bn in 2031 at the end of the forecast period.
Moving forward, both William Blair and Jefferies analysts predict that this readout will have little impact on investor sentiments towards Insmed – instead sharpening the focus on Brinsupri’s launch curve in bronchiectasis.
HS market on an upward trajectory
While Brinsupri’s HS hopes have not come to fruition, GlobalData forecasts that the HS market will reach a value of $7.83bn across the seven major markets (7MM: The US, France, Germany, Italy, Spain, the UK, and Japan) in 2034, with strong sales growth in this indication driven by the approval and uptake of next-generation drugs with novel mechanisms of action.
Currently, AbbVie’s Humira (adalimumab) and its generics lead the HS market. However, the drug is associated with modest efficacy and high treatment fatigue – highlighting the need for effective and tolerable treatment options within this patient population.
