Insmed to Present 11 Abstracts from Across Its Respiratory Portfolio at the American Thoracic Society 2025 International Conference
Insmed (INSM) will present 11 abstracts at the American Thoracic Society (ATS) 2025 International Conference in San Francisco from May 18-21, 2025. The presentations focus on their respiratory portfolio, featuring new analyses from the Phase 3 ASPEN study of brensocatib in bronchiectasis patients.
Key presentations include:
- Multiple prespecified subgroup analyses examining brensocatib's efficacy and safety
- Post-hoc analysis of lung function changes in bronchiectasis patients
- Health status improvements in patients with Mycobacterium Avium Complex (MAC) lung disease
- Clinical data from Phase 2a study of treprostinil palmitil inhalation powder in pulmonary hypertension
Chief Medical Officer Dr. Martina Flammer emphasized the significance of presenting new subgroup analyses from ASPEN, noting it as the largest Phase 3 clinical trial in bronchiectasis to date, particularly important given no treatments are specifically approved for this condition.
Insmed (INSM) presenterà 11 abstract alla Conferenza Internazionale della Società Toracica Americana (ATS) 2025 a San Francisco dal 18 al 21 maggio 2025. Le presentazioni si concentrano sul loro portafoglio respiratorio, con nuove analisi dallo studio di Fase 3 ASPEN su pazienti con bronchectasie.
Le presentazioni chiave includono:
- Analisi di sottogruppi predefiniti che esaminano l'efficacia e la sicurezza di brensocatib
- Analisi post-hoc delle variazioni della funzionalità polmonare nei pazienti con bronchectasie
- Miglioramenti dello stato di salute nei pazienti con malattia polmonare da Mycobacterium Avium Complex (MAC)
- Dati clinici dallo studio di Fase 2a di polvere di inalazione di treprostinil palmitil nell'ipertensione polmonare
Il Direttore Medico Dr. Martina Flammer ha sottolineato l'importanza di presentare nuove analisi di sottogruppo dall'ASPEN, definendola il più grande trial clinico di Fase 3 sulle bronchectasie fino ad oggi, particolarmente significativo dato che non ci sono trattamenti specificamente approvati per questa condizione.
Insmed (INSM) presentará 11 resúmenes en la Conferencia Internacional de la Sociedad Torácica Americana (ATS) 2025 en San Francisco del 18 al 21 de mayo de 2025. Las presentaciones se centran en su cartera respiratoria, destacando nuevos análisis del estudio de Fase 3 ASPEN en pacientes con bronquiectasias.
Las presentaciones clave incluyen:
- Múltiples análisis de subgrupos predefinidos que examinan la eficacia y seguridad de brensocatib
- Análisis post-hoc de los cambios en la función pulmonar en pacientes con bronquiectasias
- Mejoras en el estado de salud de pacientes con enfermedad pulmonar por Mycobacterium Avium Complex (MAC)
- Datos clínicos del estudio de Fase 2a sobre polvo de inhalación de treprostinil palmitil en hipertensión pulmonar
La Directora Médica, Dra. Martina Flammer, enfatizó la importancia de presentar nuevos análisis de subgrupos del ASPEN, señalando que es el mayor ensayo clínico de Fase 3 en bronquiectasias hasta la fecha, especialmente relevante dado que no hay tratamientos aprobados específicamente para esta condición.
Insmed (INSM)는 2025년 5월 18일부터 21일까지 샌프란시스코에서 열리는 미국 흉부 학회(ATS) 2025 국제 회의에서 11개의 초록을 발표할 예정입니다. 발표는 그들의 호흡기 포트폴리오에 중점을 두며, 기관지 확장증 환자에서 brensocatib에 대한 3상 ASPEN 연구의 새로운 분석을 포함합니다.
주요 발표 내용은 다음과 같습니다:
- brensocatib의 효능과 안전성을 조사하는 여러 사전 지정된 하위 그룹 분석
- 기관지 확장증 환자의 폐 기능 변화에 대한 사후 분석
- Mycobacterium Avium Complex (MAC) 폐 질환 환자의 건강 상태 개선
- 폐 고혈압에 대한 treprostinil palmitil 흡입 분말의 2a상 연구에서의 임상 데이터
최고 의료 책임자 Dr. Martina Flammer는 ASPEN에서 새로운 하위 그룹 분석을 발표하는 것의 중요성을 강조하며, 이는 현재까지 기관지 확장증에 대한 가장 큰 3상 임상 시험으로, 이 질환에 대해 특별히 승인된 치료법이 없다는 점에서 특히 중요하다고 언급했습니다.
Insmed (INSM) présentera 11 résumés lors de la Conférence Internationale de la Société Thoracique Américaine (ATS) 2025 à San Francisco du 18 au 21 mai 2025. Les présentations se concentrent sur leur portefeuille respiratoire, avec de nouvelles analyses de l'étude de Phase 3 ASPEN sur des patients atteints de bronchectasie.
Les présentations clés incluent:
- Plusieurs analyses de sous-groupes prédéfinis examinant l'efficacité et la sécurité de brensocatib
- Analyse post-hoc des changements de la fonction pulmonaire chez les patients atteints de bronchectasie
- Améliorations de l'état de santé des patients atteints de maladie pulmonaire à Mycobacterium Avium Complex (MAC)
- Données cliniques de l'étude de Phase 2a sur la poudre d'inhalation de treprostinil palmitil dans l'hypertension pulmonaire
La Directrice Médicale, Dr. Martina Flammer, a souligné l'importance de présenter de nouvelles analyses de sous-groupes de l'ASPEN, notant qu'il s'agit de l'essai clinique de Phase 3 le plus important sur les bronchectasies à ce jour, ce qui est particulièrement significatif étant donné qu'aucun traitement n'est spécifiquement approuvé pour cette condition.
Insmed (INSM) wird 11 Abstracts auf der American Thoracic Society (ATS) 2025 International Conference in San Francisco vom 18. bis 21. Mai 2025 präsentieren. Die Präsentationen konzentrieren sich auf ihr respiratorisches Portfolio und enthalten neue Analysen aus der Phase 3 ASPEN-Studie zu Patienten mit Bronchiektasen.
Wichtige Präsentationen umfassen:
- Mehrere vordefinierte Subgruppenanalysen zur Wirksamkeit und Sicherheit von Brensocatib
- Post-hoc-Analyse der Veränderungen der Lungenfunktion bei Patienten mit Bronchiektasen
- Verbesserungen des Gesundheitszustands bei Patienten mit Mycobacterium Avium Complex (MAC) Lungenerkrankung
- Klinische Daten aus der Phase 2a-Studie zu Treprostinil-Palmitil-Inhalationspulver bei pulmonaler Hypertonie
Die Chief Medical Officer Dr. Martina Flammer betonte die Bedeutung der Präsentation neuer Subgruppenanalysen aus ASPEN und bezeichnete es als die größte Phase-3-Studie zu Bronchiektasen bis heute, was besonders wichtig ist, da es keine spezifisch zugelassenen Behandlungen für diese Erkrankung gibt.
- None.
- None.
—New Analyses from the Phase 3 ASPEN Study Examining Efficacy and Safety of Brensocatib Across a Variety of Prespecified Subgroups—
—Data from
—Data on Health Status Improvements Over Time Following Culture Conversion in Patients with Mycobacterium Avium Complex (MAC) Lung Disease—
"Our strong presence at this year's ATS congress underscores our steadfast commitment to advancing groundbreaking research and driving innovation, with the ultimate goal of improving outcomes for patients with serious diseases worldwide," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "With no treatments specifically approved for bronchiectasis, we are especially eager to present several new subgroup analyses from
Presentations:
- Thematic Poster Session A54, Sunday, May 18, 11:30 AM–1:15 PM PT:
- Treatment Patterns and Outcomes Among Patients with Non-Cystic Fibrosis Bronchiectasis
- Hospitalizations and Risk of Readmissions in Patients with Non-Cystic Fibrosis Bronchiectasis
- Treatment Patterns and Outcomes Among Patients with Non-Cystic Fibrosis Bronchiectasis
- Mini Symposium Session B20, Monday, May 19, 10:03 AM–10:39 AM PT:
- Healthcare Resource Utilization Associated with Treatment for Refractory Mycobacterium Avium Complex Lung Disease: Comparison of Amikacin Liposome Inhalation Suspension (ALIS) vs Non-ALIS Antibiotic Treatment
- Longitudinal Health Status Improvements Following Culture Conversion in Patients with Mycobacterium Avium Complex Lung Disease
- Healthcare Resource Utilization Associated with Treatment for Refractory Mycobacterium Avium Complex Lung Disease: Comparison of Amikacin Liposome Inhalation Suspension (ALIS) vs Non-ALIS Antibiotic Treatment
- Thematic Poster Session B58, Late-Breaking Abstract, Monday, May 19, 11:30 AM–1:15 PM PT: Incidence, Prevalence and Mortality of Bronchiectasis in
England from 2015 to 2019 Using Routine Electronic Health Care Data - Thematic Poster Session B35, Monday, May 19, 11:30 AM–1:15 PM PT: Efficacy of Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis With vs Without Maintenance Use of Macrolides: An Analysis of the
ASPEN Trial - Mini Symposium Session C14, Tuesday, May 20, 11:03 AM–11:15 AM PT: Efficacy of Brensocatib in Patients with Eosinophilic Bronchiectasis: An Analysis of the
ASPEN Trial - Poster Discussion Session C29, Poster Board # 903, Tuesday, May 20, 9:15 AM–11:15 AM PT: Functional Respiratory Imaging (FRI) Markers Correlate with Clinical Endpoints in a Phase 2 Study of Treprostinil Palmitil Inhalation Powder in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
- Poster Discussion Session C107, Poster Board # 101, Tuesday, May 20, 2:15 PM–4:15 PM PT: Longitudinal Changes in St. George's Respiratory Questionnaire Scores Following Culture Conversion in Patients with Mycobacterium Avium Complex Lung Disease
- Mini Symposium Session D18, Wednesday, May 21, 8:39 AM–10:03 AM PT:
- Changes in Lung Function in Patients with Non-Cystic Fibrosis Bronchiectasis Who Did or Did Not Have On-Study Pulmonary Exacerbations: An Analysis of the
ASPEN Trial - Exacerbation Rate and Lung Function in Adolescent Patients with Non-Cystic Fibrosis Bronchiectasis: An Analysis of the
ASPEN Trial
- Changes in Lung Function in Patients with Non-Cystic Fibrosis Bronchiectasis Who Did or Did Not Have On-Study Pulmonary Exacerbations: An Analysis of the
About ARIKAYCE
ARIKAYCE is approved in
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with pulmonary arterial hypertension (PAH), PH-ILD, and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS |
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. |
Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.
Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (
Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥
Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater,
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The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE, our only approved product, in the
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact:
Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com
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Director, Investor Relations
(917) 936-8430
michael.morabito@insmed.com
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(848) 360-1281
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