A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.

Start Date16 Dec 2024

Sponsor / Collaborator

Insmed, Inc.

NCT06344728

/ CompletedPhase 1

A Phase 1, Open-Label, Randomized, Two-Period Crossover Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets Following Single Oral Doses in Healthy Subjects

The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.

Start Date30 Apr 2024

Sponsor / Collaborator

Insmed, Inc.

NCT06178783

/ CompletedPhase 1

A Phase 1, Double-blind, Randomized, Single-center Study to Assess the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Subjects

The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.

Start Date27 Dec 2023

Sponsor / Collaborator

Insmed, Inc.

100 Clinical Results associated with Brensocatib

100 Translational Medicine associated with Brensocatib

100 Patents (Medical) associated with Brensocatib

Literatures (Medical) associated with Brensocatib

01 Jun 2025·ARCHIVES OF DISEASE IN CHILDHOOD

What is brensocatib?

Article

24 Apr 2025·NEW ENGLAND JOURNAL OF MEDICINE

Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis

Article

Author: Loebinger, Michael R. ; Mange, Kevin ; Zambrano, Migdalia ; Burgel, Pierre-Régis ; De Soyza, Anthony ; Fan, Chunpeng ; Zhang, Xiangmin ; Shteinberg, Michal ; Fernandez, Carlos ; Daley, Charles L. ; Haworth, Charles S. ; Ringshausen, Felix C. ; McShane, Pamela J. ; Metersky, Mark L. ; Mauger, David ; Blasi, Francesco ; Teper, Ariel ; Chalmers, James D.

BACKGROUND:

In bronchiectasis, neutrophilic inflammation is associated with an increased risk of exacerbations and disease progression. Brensocatib, an oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP-1), targets neutrophil serine proteases, key mediators of neutrophilic inflammation.

METHODS:

In a phase 3, double-blind trial, we randomly assigned patients with bronchiectasis (in a 1:1:1 ratio for adults and a 2:2:1 ratio for adolescents) to receive brensocatib (10 mg or 25 mg once per day) or placebo. The primary end point was the annualized rate of adjudicated pulmonary exacerbations over a 52-week period. The secondary end points, listed in hierarchical testing order, were the time to the first exacerbation during the 52-week period; the percentage of patients remaining exacerbation-free at week 52; the change in forced expiratory volume in 1 second (FEV₁); the annualized rate of severe exacerbations; and change in quality of life.

RESULTS:

A total of 1721 patients (1680 adults and 41 adolescents) underwent randomization and received brensocatib or placebo. The annualized rate of pulmonary exacerbations was 1.02 in the 10-mg brensocatib group, 1.04 in the 25-mg brensocatib group, and 1.29 in the placebo group (rate ratio, brensocatib vs. placebo, 0.79 [95% confidence interval {CI}, 0.68 to 0.92; adjusted P = 0.004] with the 10-mg dose and 0.81 [95% CI, 0.69 to 0.94; adjusted P = 0.005] with the 25-mg dose). The hazard ratio for the time to the first exacerbation was 0.81 (95% CI, 0.70 to 0.95; adjusted P = 0.02) with the 10-mg dose and 0.83 (95% CI, 0.70 to 0.97; adjusted P = 0.04) with the 25-mg dose. In each brensocatib group, 48.5% of patients remained exacerbation-free at week 52, as compared with 40.3% in the placebo group (rate ratio, 1.20 [95% CI, 1.06 to 1.37; adjusted P = 0.02] with the 10-mg dose and 1.18 [95% CI, 1.04 to 1.34; adjusted P = 0.04] with the 25-mg dose). At week 52, FEV₁ had declined by 50 ml with the 10-mg dose, 24 ml with the 25-mg dose, and 62 ml with placebo (least-squares mean difference vs. placebo, 11 ml [95% CI, -14 to 37; adjusted P = 0.38] with the 10-mg dose and 38 ml [95% CI, 11 to 65; adjusted P = 0.04] with the 25-mg dose). The incidence of adverse events was similar across groups, except for a higher incidence of hyperkeratosis with brensocatib.

CONCLUSIONS:

Among patients with bronchiectasis, once-daily treatment with brensocatib (10 mg or 25 mg) led to a lower annualized rate of pulmonary exacerbations than placebo, and the decline in FEV₁ was less with the 25-mg dose of brensocatib than with placebo. (Funded by Insmed; ASPEN ClinicalTrials.gov number, NCT04594369; EudraCT number, 2020-003688-25.).

24 Apr 2025·NEW ENGLAND JOURNAL OF MEDICINE

Brensocatib in Bronchiectasis — A New Sheriff in Town?

Author: Grimwood, Keith ; Bell, Scott C.

News (Medical) associated with Brensocatib

12 Jun 2025

·www.prnewswire.com

Insmed Announces Pricing of $750 Million Public Offering of Common Stock

BRIDGEWATER, N.J., June 11, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it priced an underwritten public offering of 7,812,500 shares of its common stock at a price to the public of $96.00 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be approximately $750 million. In addition, Insmed has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock. Insmed intends to use the net proceeds from this offering to fund continued research and development of brensocatib as well as pre-commercial and, if approved, commercialization activities related to brensocatib, activities related to the further commercialization and development of ARIKAYCE® (amikacin liposome inhalation suspension), further research and development of treprostinil palmitil inhalation powder (TPIP), INS1201, and the Company's pre-clinical research product candidates, and for other general corporate purposes, including business expansion activities. Goldman Sachs & Co. LLC, Leerink Partners, BofA Securities, Jefferies and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is acting as co-lead manager for the offering. The offering is expected to close on June 13, 2025, subject to the satisfaction of customary closing conditions. The public offering of common stock described above is being made pursuant to Insmed's shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC's website at . Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected] or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. 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, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. 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: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering; failure to continue to successfully commercialize ARIKAYCE, our only approved product, in the United States ("U.S."), Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; our inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for brensocatib, TPIP or our other product candidates in the U.S., Europe or Japan or for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP, or our other product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP, or our other product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with Mycobacterium avium complex lung disease, among other things; development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP, or our other product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; the risk that the full data set from the TPIP study in pulmonary arterial hypertension ("PAH") or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that government healthcare reform materially increases our costs and damages our financial condition; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of artificial intelligence and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; the risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to ARIKAYCE, brensocatib or our other product candidates, including our license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; our limited experience operating internationally; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans. 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 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 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Study

11 Jun 2025

·www.prnewswire.com

Insmed Announces Proposed $650 Million Public Offering of Common Stock

BRIDGEWATER, N.J., June 11, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it intends to offer and sell $650 million of shares of its common stock in an underwritten public offering. In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional $97.5 million of shares of common stock. All of the shares to be sold in the offering are to be sold by Insmed. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Goldman Sachs & Co. LLC and Leerink Partners are acting as joint book-running managers for the offering. The public offering of common stock described above is being made pursuant to Insmed's shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at . Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected] or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. 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, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. 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: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering; failure to continue to successfully commercialize ARIKAYCE®, our only approved product, in the United States ("U.S."), Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; our inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for brensocatib, treprostinil palmitil inhalation powder ("TPIP") or our other product candidates in the U.S., Europe or Japan or for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP, or our other product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP, or our other product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with Mycobacterium avium complex lung disease, among other things; development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP, or our other product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; the risk that the full data set from the TPIP study in pulmonary arterial hypertension ("PAH") or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that government healthcare reform materially increases our costs and damages our financial condition; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of artificial intelligence and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; the risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to ARIKAYCE, brensocatib or our other product candidates, including our license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; our limited experience operating internationally; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans. 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 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 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

11 Jun 2025

·www.biospace.com

Insmed ‘Blows Away Expectations’ With Positive Data for Inhaled Hypertension Therapy

iStock, Deagreez Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” with an efficacy pro positions TPIP to be best-in-class in pulmonary arterial hypertension. Insmed’s investigational inhaled drug significantly improved blood flow and functional performance in patients with pulmonary arterial hypertension, according to topline Phase IIb data released on Tuesday. The drug candidate, trepostinil palmitil inhalation powder (TPIP), demonstrated a 35% placebo-adjustment reduction in pulmonary vascular resistance, a key heart function marker in pulmonary arterial hypertension (PAH) and the study’s primary endpoint. TPIP also met all of its secondary endpoints, including improving six-minute walk distance by 35.5 meters, as compared with placebo. In a note to investors Wednesday afternoon, analysts at Guggenheim Partners said Insmed’s readout “blows away expectations,” calling it “impressive across the board.” TPIP’s efficacy profile, if it remains consistent in late-stage studies, “firmly support TPIP as being the best-in-class prostacyclin,” they added. Insmed’s stock rose about 29% Tuesday after the data were announced. Guggenheim also called TPIP’s safety profile “very reassuring,” with side effects that were “consistent with other inhaled trespronstinils.” Insmed said treatment-emergent adverse events (TEAE) developed in 88.4% of patients on TPIP, versus 75.8% of placebo comparators. Serious TEAEs arose in 7.2% and 3% of participants in these respective groups. Cough emerged as a common side effect in the TPIP group, with a frequency rate of 40.6% compared to 21.2% in those receiving placebo. “While there may be some questions raised on the rates of cough in the trial,” Guggenheim noted, “we believe this is within the range of what should be expected for an inhaled product like TPIP.” Cough concerns are also “far outweighed” by TPIP’s efficacy profile, the analysts contended. With Tuesday’s data, Insmed will “immediately” approach the FDA to discuss the design for a Phase III study of TPIP in PAH, which the company expects to initiate in “early 2026,” according to Tuesday’s release. Insmed also plans to study TPIP in pulmonary hypertension associated with interstitial lung disease, for which a Phase III study is set to start before the end of the year. Writing to investors on Tuesday, analysts at Truist Securities noted that TPIP further boosts Insmed’s overall business prospects. The biotech, which has one approved therapy in the inhaled antibiotic Arikayce, is currently awaiting the FDA’s decision for its DPP1 blocker brensocatib for bronchiectasis . A verdict is expected by Aug. 12 , and Truist is optimistic, expecting an approval. “We like [Insmed’s] competitive product pro pipeline strategy,” the analysts wrote, with brensocatib as a “potential FTM [first-to-market] therapy” along with TPIP “as a potential best-in-class prostanoid treatment in PAH.” Overall, the potential of Insmed’s pipeline could make the biotech “of interest to big pharma looking for synergistic ways to fill gaps in their respiratory/pulmonary portfolios,” Truist wrote.

Phase 2Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Brensocatib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15638

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-cystic fibrosis bronchiectasis	NDA/BLA	United States	Insmed, Inc.	01 Dec 2024
Bronchiectasis	NDA/BLA	European Union	Insmed, Inc.	-
Bronchiectasis	NDA/BLA	United Kingdom	Insmed, Inc.	-
COVID-19	Phase 3	United Kingdom	Insmed, Inc.	05 Jun 2020
Hidradenitis Suppurativa	Phase 2	United States	Insmed, Inc.	16 Dec 2024
Hidradenitis Suppurativa	Phase 2	Australia	Insmed, Inc.	16 Dec 2024
Hidradenitis Suppurativa	Phase 2	Bulgaria	Insmed, Inc.	16 Dec 2024
Hidradenitis Suppurativa	Phase 2	Canada	Insmed, Inc.	16 Dec 2024
Hidradenitis Suppurativa	Phase 2	France	Insmed, Inc.	16 Dec 2024
Hidradenitis Suppurativa	Phase 2	Germany	Insmed, Inc.	16 Dec 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04594369 (ASPEN, ATS2025)	Phase 3	Non-cystic fibrosis bronchiectasis Neutrophil serine proteases (NSPs) \| neutrophil elastase	-	Brensocatib 10mg	qbpqxcywxc(zzxrmtskkt) = bjqxyhkmfo nxkfxeorkk (gyqgegrlae ) View more	Positive	16 May 2025
				Brensocatib 25mg	qbpqxcywxc(zzxrmtskkt) = tjxlznhlmd nxkfxeorkk (gyqgegrlae ) View more
NCT04594369 (ASPEN, Pubmed \| N Engl J Med)	Phase 3	Bronchiectasis neutrophilic inflammation	1,721	Brensocatib 10 mg	mitpqbgnrw(mcxratzsve) = higher incidence with brensocatib jffwzyzhwh (nwwkiktrge )	Positive	24 Apr 2025
				Brensocatib 25 mg
NCT04594369 (ASPEN, PRNewswire) Manual	Phase 3	Bronchiectasis	-	Brensocatib 10 mg	cvqfstcvdq(itpaurasrw) = jzpilqkusr cdfyfbnbmb (fybelxfizs ) View more	Positive	08 Oct 2024
				Brensocatib 25 mg	cvqfstcvdq(itpaurasrw) = ikknovfdxs cdfyfbnbmb (fybelxfizs ) View more
NCT04594369 (ASPEN, Company_Website) Manual	Phase 3	Bronchiectasis	1,721	Brensocatib 10 mg	bkislifmgs(dtqvtywqxi) = ejximrippv wxswsrcgbi (uasbczoxjp ) View more	Positive	28 May 2024
				Brensocatib 25 mg	bkislifmgs(dtqvtywqxi) = alpnrmcllu wxswsrcgbi (uasbczoxjp ) View more
NCT05673603 (ATS2024) Manual	Phase 1	Non-cystic fibrosis bronchiectasis	28	Brensocatib (Subjects with mild renal impairment)	gvszlskylg(ycsurrsejf) = There were no treatment-emergent AEs, serious AEs, or death during this study. ugnbakblof (lgdcdtvvyx )	Positive	22 May 2024
				Brensocatib (Subjects with moderate renal impairment)
NCT04817332 (STOP-COVID19, CTgov)	Phase 3	COVID-19	406	Brensocatib (Brensocatib)	crjqlygrwx = togbfgckgk zcayllbxyr (ehsllrnkdc, ffaqnhfqve - tvfexebqsu) View more	-	22 Aug 2023
				Placebo (Placebo)	crjqlygrwx = baxwbzkbae zcayllbxyr (ehsllrnkdc, lvuthceiiz - luhazwogeg) View more
ATS2023	Not Applicable	Bronchiectasis	-	Brensocatib 25mg	aljwzxryfm(rsmavykrdi) = dredutlflz kztumnetkk (dpvkfowxxv )	-	21 May 2023
				Placebo	aljwzxryfm(rsmavykrdi) = ctdtpaquar kztumnetkk (dpvkfowxxv )
NCT03218917 (WILLOW, CTgov)	Phase 2	Non-cystic fibrosis bronchiectasis	256	Brensocatib 10 mg (Brensocatib 10 mg)	gjofizozod(vvlnvggkdc) = cdsgvootrw owrblxzubi (nvwpxgpypa, xvciaggfkf - yxoflygvzk) View more	-	08 Feb 2023
				Brensocatib 25 mg (Brensocatib 25 mg)	gjofizozod(vvlnvggkdc) = ouaaiiluhc owrblxzubi (nvwpxgpypa, jwonskskqb - agqhgxeqod) View more
Pubmed \| Clin Pharmacol Drug Dev	Phase 1	-	-	Brensocatib 10mg	gfjtjltmap(kokssaxppi) = The most frequently reported treatment-emergent adverse events were headache dxhfffyiul (fgxbnmhdym ) View more	-	01 Jul 2022
				Brensocatib 40mg
NCT04817332 (NEWS) Manual	Phase 3	COVID-19	404	Standard of Care+brensocatib	befrifumps(qtllanuumw) = Brensocatib did not improve the clinical status of patients hospitalized jiqseyrrtl (xembdikxsp ) View more	Negative	18 May 2022
				Standard of Care+Placebo

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis