Treprostinil

WALTHAM, Mass., Sept. 06, 2026 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced that results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented at the European Respiratory Society (ERS) International Congress 2026 at 12:15 CEST (6:15 a.m. ET) on Tuesday, September 8, 2026, by Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension. Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD. The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial that enrolled 135 adult participants with PH-ILD to assess the safety and efficacy of mosliciguat. Mosliciguat is also being evaluated in the Phase 2 PHactor clinical study (NCT07333183), an open-label trial evaluating the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD. About Pulmonary Hypertension and Interstitial Lung DiseasePulmonary hypertension (PH) is a progressive and debilitating condition characterized by high blood pressure in the blood vessels of the lungs. This elevated pressure forces the heart to work harder to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, chest pain, and dizziness. The World Health Organization (WHO) has classified PH into five groups based on their underlying causes, symptoms, and treatment approaches. Group 3 PH is a subtype of PH that arises from lung diseases, such as interstitial lung disease (ILD). ILD describes a large group of diseases that cause progressive damage to the lungs, making it difficult for patients to breathe. Up to 200,000 patients across the U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options. For more information, please visit https://www.pulmovant.com/our-science. About MosliciguatMosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action, which may have broad application across the spectrum of pulmonary hypertension (PH). Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production. Elevated cGMP levels are known to promote vasodilation, contribute to anti-fibrotic effects, reduce inflammation and apoptosis and reverse vascular remodeling. Unlike sGC stimulators, which require reduced heme and NO to exert their effect, mosliciguat is an sGC activator that is believed to work independently of heme and NO. In the Phase 1b ATMOS study of mosliciguat, a single dose of inhaled mosliciguat in PH patients was well tolerated and led to clinically meaningful, mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%, one of the highest reductions seen in pulmonary hypertension trials to date. For information on the Phase 2 PHocus study of mosliciguat, please visit https://phocusstudy.com. About PulmovantPulmovant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant (Nasdaq: ROIV) company. Pulmovant’ s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 2 PHocus global clinical trial in PH-ILD. For more information, please visit https://www.pulmovant.com. About Roivant Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. © 2026 Pulmovant, Inc. All Rights Reserved. All trademarks are the property of their respective owners. Contactinquiries@pulmovant.com

每日呼吸病学全球动态本专栏汇总过去24小时全球呼吸领域前沿资讯，聚焦临床研究、药物获批、指南更新与学术会议重磅成果，供临床及学术参考，内容仅作信息交流，不构成诊疗建议。1. FDA受理吸入曲前列尼尔（Tyvaso）治疗IPF的sNDA，有望成为首个吸入抗纤维化疗法核心内容：2026年9月2日，United Therapeutics（Nasdaq: UTHR）宣布，美国FDA已受理雾化吸入Tyvaso（曲前列尼尔，treprostinil）吸入溶液用于治疗特发性肺纤维化（IPF）的补充新药申请（sNDA）。该申请基于TETON-1和TETON-2两项III期注册试验的阳性合并分析结果，显示吸入曲前列尼尔较安慰剂显著减少FVC下降（合并分析组间差异111mL）和临床恶化事件。FDA预计将于2027年4月底完成审查。该药物已获得美国和欧盟的孤儿药资格认定。重要性理由：IPF治疗领域十余年来仅有尼达尼布和吡非尼酮两种口服抗纤维化药物，且只能延缓疾病进展而无法逆转。吸入曲前列尼尔通过前列环素通路发挥作用，与现有抗纤维化药物机制互补，若获批将成为全球首个FDA批准的吸入抗纤维化治疗，为IPF患者提供全新的给药途径和联合治疗选择，可能改变IPF的治疗范式。信息来源：United Therapeutics官方公告 / HCPLive / Consultant Live（2026-09-02/03发布）链接：https://www.hcplive.com/view/fda-accepts-nebulized-treprostinil-snda-for-idiopathic-pulmonary-fibrosis2. ERS 2026国际大会明日开幕，多项late-breaking重磅试验即将公布核心内容：2026年欧洲呼吸学会（ERS）国际大会将于9月5日至9日在西班牙巴塞罗那举行。据HCPLive前瞻报道，本次大会将公布多项具有里程碑意义的late-breaking试验：COPD领域将公布首个IL-33受体拮抗剂预防急性加重的III期数据、首个嗜酸粒细胞指导ICS治疗的前瞻性随机试验（COPERNICUS）、以及COPD无心血管疾病患者使用β受体阻滞剂的直接答案；哮喘领域将公布抗TSLP生物学的下一代研究数据；间质性肺病领域也有多项新机制药物的II期数据。重要性理由：ERS大会是全球呼吸病学领域最高级别的学术会议之一，其late-breaking试验往往直接影响后续指南更新和临床实践。本次大会聚焦COPD治疗的”治疗性扩张”时代，IL-33通路靶向药物若III期阳性，将标志着COPD生物制剂治疗进入多靶点时代；嗜酸粒细胞指导的ICS策略首次获得前瞻性随机证据，可能改变COPD的个体化治疗决策。大会距开幕仅1天，值得高度关注。信息来源：HCPLive / Consultant Live（2026-09-01发布）链接：https://www.hcplive.com/view/ers-congress-2026-preview-late-breaking-trials3. GOLD 2026指南重大更新解读发表，COPD管理进入早期干预与个体化治疗新时代核心内容：一篇发表在PMC的深度解读文章系统梳理了GOLD 2026指南的重大变革。最显著的变化涉及Group E的重新定义：根据2026 GOLD指南，既往一年中有至少一次中度或重度急性加重的患者均被视为高风险，应启动LABA/LAMA联合治疗，该推荐基于Meta分析证据，显示双支气管扩张剂在预防急性加重方面 consistently 优于单药或LABA/ICS联合。此外，GOLD 2026强调早期干预、多维评估（包括症状、急性加重史、肺功能、合并症等）和个体化治疗策略。重要性理由：GOLD指南是全球COPD管理最具影响力的临床实践指南，其更新直接影响全球数亿COPD患者的治疗决策。GOLD 2026对Group E的重新定义和LABA/LAMA早期联合治疗的推荐，可能显著改变COPD的初始治疗策略，使更多患者从早期即接受更有效的双支气管扩张剂治疗。强调多维评估和个体化治疗也符合当前精准医学的发展趋势。信息来源：PMC / Therapeutic Advances in Chronic Disease（2026年发表）链接：https://pmc.ncbi.nlm.nih.gov/articles/PMC13109179/pdf/40265_2026_Article_2303.pdf4. Beam Therapeutics将在ERS 2026公布BEAM-302碱基编辑基因疗法治疗α-1抗胰蛋白酶缺乏症的I/II期更新数据核心内容：Beam Therapeutics（Nasdaq: BEAM）宣布，将在ERS 2026大会上以late-breaking口头报告形式公布BEAM-302治疗α-1抗胰蛋白酶缺乏症（AATD）的I/II期临床试验更新数据。BEAM-302是一种体内碱基编辑基因疗法，通过精准编辑SERPINA1基因的致病突变，恢复α-1抗胰蛋白酶的正常表达。AATD是一种遗传性疾病，可导致早发性肺气肿和肝病，目前治疗手段有限。重要性理由：碱基编辑基因疗法代表了呼吸系统遗传病治疗的最前沿方向。AATD是单基因遗传病，理论上非常适合基因编辑治疗。BEAM-302是呼吸领域少数进入临床阶段的体内碱基编辑疗法之一，如果I/II期数据显示良好的安全性和有效性，将为AATD患者提供潜在的治愈性治疗，并为其他呼吸系统单基因遗传病（如囊性纤维化）的基因编辑治疗奠定基础。信息来源：Beam Therapeutics官方公告（2026-07-23发布，ERS 2026 late-breaking口头报告）链接：https://investors.beamtx.com/news-releases/news-release-details/beam-therapeutics-present-updated-data-phase-12-trial-beam-3025. 健康饮食与哮喘/COPD患者更好的肺功能及更慢的肺功能下降相关核心内容：2026年8月27日Medscape报道，一项发表在ERJ Open Res上的研究显示，与无哮喘或COPD的人群相比，更健康的饮食与哮喘或COPD成人患者更好的肺功能相关，同时也与更慢的肺功能下降速度相关。该研究分析了饮食质量与肺功能指标（包括FEV1、FVC等）之间的关联，提示饮食干预可能作为哮喘和COPD管理的辅助策略。重要性理由：哮喘和COPD是最常见的慢性呼吸系统疾病，药物治疗是主要管理手段，但生活方式干预的作用日益受到重视。该研究为饮食干预在慢性气道疾病管理中的价值提供了新的循证证据，提示临床医生在药物治疗之外，应关注患者的饮食质量，并可能将健康饮食建议纳入慢性气道疾病的综合管理方案。虽然为观察性研究，不能确立因果关系，但为后续干预性研究提供了方向。信息来源：Medscape / ERJ Open Res（2026-08-27报道，DOI:10.1183/23120541.01559-2025）链接：https://www.medscape.com/viewarticle/healthy-diet-may-aid-lung-health-adults-asthma-or-chronic-2026a1000twr6. IPF患者肺功能和运动能力的动态变化是死亡率的强预测因子核心内容：一项发表在Frontiers in Medicine的研究显示，在接受抗纤维化治疗的IPF患者中，12个月内肺功能和运动能力的动态变化是死亡率的强独立预测因子。研究发现，FVC下降≥5.8%和DLco下降≥11.5%的患者死亡率显著增加。这些动态生理指标比静态基线测量更能预测预后，强调了在IPF患者管理中定期监测肺功能和运动能力的重要性。重要性理由：IPF是一种进行性致死性疾病，准确的预后评估对治疗决策和患者咨询至关重要。该研究提供了IPF患者接受抗纤维化治疗后预后评估的新指标，明确了FVC和DLco动态变化的临床阈值，有助于临床医生识别高风险患者并及时调整治疗策略。研究结果支持将动态生理指标纳入IPF的常规风险分层和个体化治疗决策。