Insmed在 CHEST 2026大会上展示评估曲前列尼尔棕榈酸酯吸入粉雾剂（TPIP）的全球 III期 PALM临床开发项目-动脉网

Insmed Features the Global Phase 3 PALM Clinical Development Program Evaluating Treprostinil Palmitil Inhalation Powder (TPIP) at CHEST 2026

PR Newswire 等信源发布 2026-10-15 19:00

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—Insmed's Largest Parallel-Running Clinical Effort to Date With Four Pivotal Phase 3 Studies Advancing Across Four Progressive Pulmonary Diseases: PALM-PAH, PALM-ILD, PALM-PPF, and PALM-IPF—

—Insmed迄今为止规模最大的并行开展的临床工作，四项关键性III期研究在四种进行性肺部疾病中同步推进：PALM-PAH、PALM-ILD、PALM-PPF和PALM-IPF—

—One of the Broadest Active Global Clinical Programs in the Pulmonary Space, With the Potential to Redefine Prostanoid Therapy for These Patient Populations—

—肺部疾病领域最广泛的活跃全球临床项目之一，有望重新定义针对这些患者群体的前列环素类药物治疗—

BRIDGEWATER, N.J.

新泽西州布里奇沃特

，

Oct. 15, 2026

2026年10月15日

/PRNewswire/ -- Insmed Incorporated (Nasdaq:

/美通社/ -- Insmed公司（纳斯达克：

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, will feature the global PALM Clinical Development Program at the American College of Chest Physicians

），一家以人为本的全球生物制药公司，致力于为面临严重疾病的患者提供首创新药和同类最优疗法，以改变他们的生活，将在美国胸科医师学会会议上展示其全球PALM临床开发计划。

注册商标符号

Annual Meeting 2026 (CHEST 2026), which is investigating treprostinil palmitil inhalation powder (TPIP) in a range of serious pulmonary diseases. The PALM Clinical Development Program includes four pivotal, parallel-running Phase 3 studies evaluating TPIP as a once-daily therapy for patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF).

2026年年会（CHEST 2026），该会议正在探讨曲前列尼尔棕榈酸酯吸入粉雾剂（TPIP）在多种严重肺部疾病中的应用。PALM临床开发计划包括四项同步开展的关键性III期研究，评估TPIP作为每日一次疗法用于肺动脉高压（PAH）、间质性肺病相关肺高血压（PH-ILD）、进行性肺纤维化（PPF）和特发性肺纤维化（IPF）患者的疗效。

Three PALM Phase 3 studies (PALM-PAH, PALM-ILD, PALM-PPF) have now been initiated, with the fourth study (PALM-IPF) expected to begin in the first half of 2027. This program aims to enroll more than 2,000 patients across these four studies. .

三项PALM III期研究（PALM-PAH、PALM-ILD、PALM-PPF）现已启动，第四项研究（PALM-IPF）预计于2027年上半年开始。该计划旨在在这四项研究中招募超过2,000名患者。

'People living with debilitating pulmonary diseases often face substantial burdens as their disease progresses, compounded by complex treatment regimens and systemic side effects that can make the demands of everyday life increasingly difficult,' said Raymond Benza, MD, Chair of Cardiology, Sentara Health and Section Chief of Cardiology at the Macon & Joan Brock Virginia Health Sciences, Eastern Virginia Medical School at Old Dominion University.

“患有致残性肺部疾病的患者随着病情进展，往往面临沉重的负担，而复杂的治疗方案以及全身性副作用更使这种负担雪上加霜，令日常生活的要求愈发难以应对。”美国东弗吉尼亚医学院（隶属于欧道明大学）梅肯与琼·布洛克弗吉尼亚健康科学部心脏病学主任、森塔拉健康系统心脏病学主席雷蒙德·本扎医学博士表示。

'As clinicians, we see firsthand the need to address the progressive nature of these diseases while considering the demands of long-term therapy. The PALM Clinical Development Program has the potential to demonstrate the impact of a novel, once-daily inhaled prostanoid therapy for patients across four serious pulmonary diseases.'.

“作为临床医生，我们亲眼目睹了在考虑长期治疗需求的同时，应对这些疾病渐进性特征的必要性。PALM 临床开发项目有望展示一种新型、每日一次吸入式前列环素疗法对四种严重肺部疾病患者的影响。”

Building on clinically meaningful Phase 2 efficacy and safety data evaluating TPIP in PAH and PH-ILD, the PALM Clinical Development Program is driven by the urgency to address treatment challenges and advance the standard of care for patients living with these serious diseases. The program is designed to establish investigational TPIP as a highly differentiated, purposefully designed, once-daily therapy with the potential to deliver meaningful outcomes across a broad range of patients.

基于在肺动脉高压（PAH）和间质性肺病相关肺高血压（PH-ILD）中评估TPIP的具有临床意义的II期疗效和安全性数据，PALM临床开发计划旨在应对治疗挑战并推进这些严重疾病患者的护理标准。该计划旨在将研究性药物TPIP确立为一种高度差异化、专门设计、每日一次的疗法，有望为广泛患者群体带来有意义的临床结局。

Background on each of the studies is as follows:.

各项研究的背景如下：

PALM-PAH

is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the efficacy and safety of once-daily TPIP in patients with PAH (World Health Organization [WHO] Group 1 pulmonary hypertension) over 24 weeks. The primary endpoint is change from baseline in 6-minute walk distance (6MWD) at Week 24.

这是一项III期、随机、双盲、安慰剂对照、多中心、平行组研究，旨在评估每日一次TPIP在肺动脉高压（PAH，世界卫生组织[WHO]第1组肺高血压）患者中为期24周的疗效和安全性。主要终点为第24周时6分钟步行距离（6MWD）较基线的变化。

Secondary endpoints assess functional status, disease severity, patient-reported outcomes, time to first clinical worsening, and pharmacokinetics (ClinicalTrials.gov ID: .

次要终点评估功能状态、疾病严重程度、患者报告结局、首次临床恶化的时间以及药代动力学（ClinicalTrials.gov ID：

NCT07481981

）。

PALM-ILD

进行性纤维化性间质性肺病

is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the efficacy and safety of once-daily TPIP in patients with PH-ILD (WHO Group 3 pulmonary hypertension) over 24 weeks. The primary endpoint is change from baseline in 6MWD at Week 24, with time to first major morbidity or mortality event over the 24-week treatment period as a secondary endpoint (ClinicalTrials.gov ID: .

这是一项III期、随机、双盲、安慰剂对照、多中心、平行组研究，旨在评估每日一次TPIP在PH-ILD（WHO第3组肺高血压）患者中为期24周的疗效和安全性。主要终点为第24周时6分钟步行距离（6MWD）较基线的变化，次要终点为24周治疗期内首次发生重大发病率或死亡率事件的时间（ClinicalTrials.gov ID：）。

NCT07179380

）。

PALM-PPF

is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the safety and efficacy of once-daily TPIP in adult patients with PPF over 52 to 104 weeks. The study's primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52, with secondary endpoints assessing disease progression, functional and physiological decline, patient-reported impact, pharmacokinetics, and safety (ClinicalTrials.gov ID: .

是一项III期、随机、双盲、安慰剂对照、多中心、平行组研究，旨在评估每日一次TPIP在成人PPF患者中治疗52至104周的安全性和有效性。该研究的主要终点是第52周时绝对用力肺活量（FVC）较基线的变化，次要终点包括评估疾病进展、功能和生理功能下降、患者报告的影响、药代动力学和安全性（ClinicalTrials.gov ID：）。

NCT07805785

）。

PALM-IPF

will be a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the safety and efficacy of once-daily TPIP in adult patients with IPF over 52 to 104 weeks. The study's primary endpoint will be change from baseline in absolute FVC at Week 52, with secondary endpoints assessing disease progression, functional and physiological decline, and patient-reported impact, pharmacokinetics, and safety (ClinicalTrials.gov listing forthcoming)..

这将是一项III期、随机、双盲、安慰剂对照、多中心、平行组研究，旨在评估每日一次TPIP在特发性肺纤维化（IPF）成年患者中为期52至104周的安全性和有效性。研究的主要终点为第52周时绝对用力肺活量（FVC）较基线的变化，次要终点包括评估疾病进展、功能和生理功能下降、患者报告的影响、药代动力学以及安全性（ClinicalTrials.gov注册信息即将公布）。

'As TPIP continues into the next stage of clinical development, this multi-indication PALM Clinical Development Program — the most ambitious clinical effort we are undertaking to date — is designed to break through treatment barriers that have historically limited innovation of prostanoid treatment for these complex pulmonary disorders,' said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed.

“随着TPIP进入临床开发的下一阶段，这项多适应症的PALM临床开发计划——我们迄今为止开展的最具雄心的临床工作——旨在突破历来限制前列腺素类药物治疗这些复杂肺部疾病创新的 Treatment 壁垒。”Insmed公司首席医学官Martina Flammer医学博士、工商管理硕士表示。

'These four Phase 3 studies further evaluate TPIP's potential to meaningfully improve care and, if successful, emerge as the prostanoid of choice for clinicians and patients.'.

“这四项三期临床研究进一步评估了TPIP在切实改善患者护理方面的潜力，如果成功，有望成为临床医生和患者首选的前列腺素类药物。”

About TPIP

关于 TPIP

Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a next-generation pro-drug formulation of inhaled treprostinil consisting of treprostinil linked by an ester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being developed as a once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF).

曲前列尼尔棕榈酸酯吸入粉雾剂（TPIP）是曲前列尼尔棕榈酸酯的一种研究用干粉制剂，而曲前列尼尔棕榈酸酯是一种新一代的吸入用曲前列尼尔前药制剂，由曲前列尼尔通过酯键连接至一条16碳链构成。TPIP完全在Insmed公司的实验室中设计开发，是一种具有高度差异化潜力的前列腺素类药物，正被开发为每日一次的治疗方案，用于治疗肺动脉高压（PAH）、间质性肺病相关肺高血压（PH-ILD）、进行性肺纤维化（PPF）以及特发性肺纤维化（IPF）患者。

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..

TPIP 通过一种基于胶囊的吸入装置给药。TPIP 是一种研究性药物产品，尚未在任何司法管辖区获得任何适应症的批准。

About Pulmonary Arterial Hypertension

关于肺动脉高压

Pulmonary arterial hypertension (PAH), classified as WHO Group 1 Pulmonary Hypertension, is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness.

肺动脉高压（PAH）被归类为世界卫生组织（WHO）第一组肺高血压，是一种严重、进行性且罕见的疾病，其特征是肺部血管狭窄或阻塞，导致肺动脉血压升高。最常见的症状包括呼吸急促、胸痛、头晕或晕厥、疲劳以及虚弱。

Untreated PAH can be debilitating and often fatal..

未经治疗的肺动脉高压可致严重功能障碍，且常危及生命。

About Pulmonary Hypertension Associated With Interstitial Lung Disease

关于间质性肺病相关的肺动脉高压

Pulmonary hypertension associated with interstitial lung disease (PH-ILD), also known as WHO Group 3 Pulmonary Hypertension, is a common and serious complication of several interstitial lung diseases (ILDs), a group of more than 200 chronic lung disorders marked by inflammation and fibrosis of the lung tissue.

与间质性肺病相关的肺动脉高压（PH-ILD），也称为世界卫生组织（WHO）第3组肺动脉高压，是多种间质性肺病（ILDs）常见且严重的并发症。间质性肺病是一组包含200多种慢性肺部疾病的统称，其特征为肺组织的炎症和纤维化。

PH-ILD is strongly associated with impaired quality of life, decreased functional capacity, greater supplemental oxygen requirements, increased risk of hospitalizations, and higher mortality..

PH-ILD 与生活质量受损、功能能力下降、补充氧气需求增加、住院风险升高以及死亡率增高密切相关。

About Progressive Pulmonary Fibrosis

关于进行性肺纤维化

Progressive pulmonary fibrosis (PPF) is a clinical phenotype that can occur across multiple interstitial lung diseases (ILDs) and is characterized by worsening lung fibrosis over time despite treatment of the underlying disease. As fibrosis progresses, patients may experience decline in lung function accompanied by worsening breathlessness during exercise and daily activities.

进行性肺纤维化（PPF）是一种可出现在多种间质性肺病（ILD）中的临床表型，其特征是尽管对基础疾病进行了治疗，但肺纤维化仍随时间推移而恶化。随着纤维化的进展，患者可能会出现肺功能下降，并伴有运动及日常活动中呼吸困难加重的情况。

Over time, disease progression can lead to significant disability, respiratory failure, and premature death. .

随着时间的推移，疾病进展可能导致严重的残疾、呼吸衰竭和过早死亡。

About Idiopathic Pulmonary Fibrosis

关于特发性肺纤维化

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterized by irreversible scarring of the lungs and a continual decline in lung function. Patients commonly experience worsening shortness of breath and persistent cough, which can significantly impact daily activities and quality of life. .

特发性肺纤维化（IPF）是一种慢性、进行性肺部疾病，其特征是肺部出现不可逆的瘢痕形成以及肺功能持续下降。患者常出现日益加重的气短和持续性咳嗽，这会严重影响日常活动和生活质量。

About Insmed

关于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 — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest.

Insmed Incorporated 是一家以人为本的全球性生物制药公司，致力于提供同类首创和同类最佳的疗法，以改变面临严重疾病患者的生活。公司正在推进一个多元化的产品组合，包括已获批药物以及处于中后期阶段的在研药物——其中包含两款用于治疗慢性、致残性肺部疾病的获批疗法——同时开展前沿的药物发现工作，专注于服务需求最迫切的患者群体。

Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates..

Insmed的商业产品组合和临床研发管线围绕三大治疗领域进行布局：呼吸系统、免疫学与炎症，以及神经与其他罕见病。公司的研发引擎正在推进广泛的技术和治疗模式，包括基因疗法、人工智能驱动的蛋白质工程、RNA末端连接以及合成 rescue 技术，以发掘未来的管线候选药物。

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Visit

Insmed 总部位于新泽西州布里奇沃特，在美国、欧洲和日本设有办事处和研发机构。访问

www.insmed.com

to learn more or follow us on

了解更多或在以下平台关注我们

领英

，

Instagram

，

YouTube

, and

，和

。

Forward-looking Statements

前瞻性陈述

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.

本新闻稿包含涉及重大风险和不确定性的前瞻性陈述。根据1995年《私人证券诉讼改革法案》的定义，“前瞻性陈述”是指非历史事实的陈述，并涉及多种风险和不确定性。

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. .

本文中的“可能”、“将”、“应当”、“可以”、“会”、“预期”、“计划”、“预计”、“相信”、“估计”、“规划”、“预测”、“打算”、“潜在”、“继续”等词语以及类似表述（以及其他提及未来事件、条件或情形的词语或表述）可能用于识别前瞻性陈述。

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.

本新闻稿中的前瞻性陈述基于公司当前的预期和信念，涉及已知和未知的风险、不确定性及其他因素，这些可能导致公司的实际结果、业绩和成就以及某些事件的发生时间与任何前瞻性陈述中讨论、预测、预期或指示的结果、业绩、成就或时间存在重大差异。

Such risks, uncertainties and other factors include, among others, the following: failure to successfully conduct the Company's current and future clinical trials for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for 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 or agreements with the Company; failure to obtain regulatory approval for TPIP in any or all of the indications for which approval is being sought; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third.

此类风险、不确定性和其他因素包括但不限于以下各项：未能成功开展本公司针对TPIP的当前及未来临床试验，其中包括因本公司可能无法招募或保留足够患者以开展并完成试验，或无法生成监管审批所需数据等原因；出现与TPIP相关的意外安全性或有效性问题；本公司所依赖的第三方未能生产满足临床需求的足量TPIP、未能开展本公司的临床试验，或未能遵守影响本公司业务或与本公司协议的法律法规及协议条款；未能就TPIP在申请的全部或部分适应症中获得监管批准；本公司对TPIP潜在市场规模的估计不准确，或用于识别医师的数据存在偏差；若TPIP获得批准，患者接受率、预期治疗时长、患者依从率或停药率可能与预期不符；本公司或本公司的第三方生产商未能遵守与TPIP相关的监管要求；本公司未能从政府或第三方获得充分的报销。

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.

公司可能无法实际实现其前瞻性陈述所指示的结果、计划、意图或预期，因为前瞻性陈述就其性质而言涉及风险和不确定性，因其与未来可能发生或不发生的事件相关并取决于相应情况。

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, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC). .

有关可能影响本公司业务的风险和不确定性的更多信息，请参阅本公司截至2025年12月31日止年度的10-K表年报中“风险因素”（第1A项）所讨论的因素，以及本公司随后向美国证券交易委员会（SEC）提交的任何文件。

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. .

本公司提醒读者，不要过度依赖任何此类前瞻性陈述，这些陈述仅反映本新闻稿发布之日的情况。除法律和证券交易委员会（SEC）规则明确要求的以外，本公司不承担任何公开更新或修订任何此类陈述的义务，以反映预期变化或此类陈述所依据的事件、条件或情况的变化，或可能影响实际结果与前瞻性陈述中所述结果存在差异的可能性的变化。

Contact:

联系方式：

Investors:

投资者：

Gianna De Palma

吉安娜·德帕尔马

Associate Director, Investor Relations

投资者关系副总监

[email protected]

Media:

媒体：

Claire Mulhearn