Insmed Incorporated (NASDAQ:INSM) on Tuesday shared the Phase 2b CEDAR study results for brensocatib.



The study did not meet its primary or secondary efficacy endpoints, leading Insmed to discontinue its hidradenitis suppurativa program.



<h2>Insmed Discontinues Failed Program</h2>



The Phase 2b CEDAR study, which evaluated brensocatib in adult patients with moderate to severe hidradenitis suppurativa, failed to meet its primary or secondary efficacy endpoints.



Brensocatib showed no efficacy, with the placebo arm outperforming both brensocatib arms.



At Week 16, study participants experienced a 45.5% and 40.3% reduction from baseline in total abscess and inflammatory nodule (AN) count in the brensocatib 10 mg and 40 mg arms, respectively, compared to a 57.1% reduction in the placebo arm.



Despite the disappointing results, the treatment was well-tolerated, with no new safety signals identified even at the highest dose of 40 mg.



<h2>Analyst Flags Predictable Outcome</h2>



William Blair wrote, “The failure of the CEDAR study does not come as a surprise, given the challenges in HS clinical trials (particularly due to high placebo response rates) and the lack of preclinical evidence to support DPP1 inhibition in the indication.”



Considering these factors and the prior failure of the BiRCh study in CRSsNP, analyst Matt Phipps writes that investor expectations were very low for the CEDAR study readout.



WilliamBlair expects that continued commercial execution on the Brinsupri launch in bronchiectasis can drive continued upside to shares and reiterates an Outperform rating.



In March, Insmed’s Phase 3b ENCORE study of Arikayce met primary and all multiplicity-controlled secondary culture conversion endpoints for lung infection.



<h2>Insmed Competitive Landscape Highlights Divergence</h2>



In March, MoonLake Immunotherapeutics (NASDAQ:MLTX) reported long-term results from its VELA-1 and VELA-2 Phase 3 clinical trials of sonelokimab in patients with hidradenitis suppurativa (HS).



MoonLake announced that 62% of patients treated with sonelokimab achieved a HiSCR75 response by Week 40, setting a new standard for long-term lesion control in HS.



Analyst Consensus &amp; Recent Actions: Insmed stock carries a Buy Rating with an average price target of $206.81. Recent analyst moves include:



<ul>
<li>Barclays: Overweight (Raises Target to $237.00) (April 1)</li>



<li>Morgan Stanley: Upgraded to Overweight (Raises Target to $212.00) (March 30)</li>



<li>HC Wainwright &amp; Co.: Buy (Raises Target to $245.00) (March 26)</li>
</ul>



INSM Stock Price Activity: Insmed shares were up 0.86% at $164.44 during premarket trading on Wednesday, according to Benzinga Pro data.



Image via Shutterstock

Insmed Incorporated has halted its hidradenitis suppurativa program after the Phase 2b CEDAR study for brensocatib failed to meet primary and secondary efficacy endpoints. The study showed no efficacy, with the placebo outperforming treatment arms. Analysts noted predictable outcomes due to high placebo response rates and low investor expectations. Despite the setback, Insmed's focus shifts to Brinsupri and Arikayce, with analysts maintaining a Buy rating and positive price targets for the stock, which saw a slight increase in premarket trading.

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