Insmed Announces Positive Topline Results from Landmark ASPEN Study of Brensocatib in Patients with Bronchiectasis
—Phase 3 Study Achieves Primary Endpoint for Both Dosage Strengths of Brensocatib with Statistically Significant and Clinically Meaningful Reduction in Frequency of Pulmonary Exacerbations Versus Placebo—
—Treatment with Brensocatib Also Achieves Statistical Significance on Multiple Secondary Endpoints for Both Dosage Strengths Versus Placebo—
—Brensocatib Well-Tolerated at Both Dosage Strengths—
—Results from
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—Insmed to Host Investor Call at
Based on these results,
Topline efficacy results from the
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Brensocatib 10 mg |
Brensocatib 25 mg |
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Primary Endpoint |
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Reduction in annualized rate of PEs |
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21.1 % |
p=0.0019* |
19.4 % |
p=0.0046* |
Secondary Endpoints |
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Prolongation of time to first PE |
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18.7 % |
p=0.0100* |
17.5 % |
p=0.0182* |
Increase in odds of remaining exacerbation free over 52 weeks |
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41.2 % |
p=0.0059* |
40.0 % |
p=0.0074* |
Change from baseline in post-bronchodilator forced |
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11 mL |
p=0.3841 |
38 mL |
p=0.0054* |
Reduction in annualized rate of severe PEs |
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25.8 % |
p=0.1277 |
26.0 % |
p=0.1025 |
Change from baseline in the Quality of Life – |
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2.0 points |
p=0.0594 |
3.8 points |
p=0.0004^ |
*Statistically significant |
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^Nominally significant p-value |
"I am thrilled that the
As part of the
Brensocatib was well-tolerated in the study. Treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients treated with either dose of brensocatib and more frequently than in placebo were COVID-19 (15.8%, 20.9%, 15.8%), nasopharyngitis (7.7%, 6.3%, 7.6%), cough (7.0%, 6.1%, 6.4%), and headache (6.7%, 8.5%, and 6.9%) for brensocatib 10 mg, brensocatib 25 mg, and placebo, respectively. Additional TEAEs and treatment-emergent adverse events of special interest (TEAESIs) are as follows:
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Brensocatib 10 mg |
Brensocatib 25 mg |
Placebo |
Any TEAE, n (%) |
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452 (77.7) |
440 (76.7) |
448 (79.6) |
Severe TEAE, n (%) |
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74 (12.7) |
67 (11.7) |
90 (16.0) |
Serious TEAE, n (%) |
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101 (17.4) |
97 (16.9) |
108 (19.2) |
TEAE leading to death, n (%) |
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3 (0.5) |
4 (0.7) |
7 (1.2) |
TEAE leading to treatment |
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25 (4.3) |
22 (3.8) |
23 (4.1) |
TEAESIs, n (%) |
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42 (7.2) |
56 (9.8) |
53 (9.4) |
Hyperkeratosis, n (%) |
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8 (1.4) |
17 (3.0) |
4 (0.7) |
Periodontal/gingival event, n (%) |
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8 (1.4) |
12 (2.1) |
15 (2.7) |
Severe infection, n (%) |
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4 (0.7) |
7 (1.2) |
4 (0.7) |
Pneumonia, n (%) |
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23 (4.0) |
27 (4.7) |
33 (5.9) |
"We are incredibly excited about the topline results from the pivotal
Brensocatib has received Breakthrough Therapy Designation from the FDA and was granted access to the Priority Medicines (PRIME) scheme by the
Conference Call
A replay of the conference call will be accessible approximately one hour after its completion through June 27, 2024, by dialing (800) 770-2030 (
About Bronchiectasis
Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Bronchiectasis affects approximately 450,000 patients in the
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by
About Insmed
Forward-Looking Statements
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Contact:
Investors:
Executive Director, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com
Eleanor Barisser
Associate Director, Investor Relations
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Executive Director, Corporate Communications
(732) 718-3621
amanda.fahey@insmed.com
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