Pulmovant, Inc.

Liquidia, Pulmovant, and Gossamer Bio Partner with Nonprofit to Showcase Cutting-Edge Clinical Trials and Breakthrough Therapies LOS ANGELES, April 1, 2025 /PRNewswire/ -- phaware® global association is set to launch an exclusive series of special edition episodes of its acclaimed "I'm Aware That I'm Rare: the phaware® podcast," delving into the fast-evolving world of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD). Kicking off on April 7th, this captivating series will feature top-tier PH-ILD experts exploring clinical breakthroughs and transformative therapies that are reshaping the treatment landscape. Continue Reading I'm Aware That I'm Rare: the phaware® podcast Explore the Latest Innovations In PH-ILD Sponsored by Liquidia, Pulmovant, and Gossamer Bio, this series of episodes highlights the cutting-edge research propelling PH-ILD advancements while emphasizing "why early intervention matters" in optimizing patient outcomes. Featured Medical Experts Include: Drs. Rajan Saggar (UCLA), Ronald Zolty (UNMC), Raj Parikh (Hartford Hospital), Ioana Preston (Lahey Hospital), Richard Channick (UCLA), Jean Elwing (University of Cincinnati), and Marc Simon (UCSF). Championing a New Era in PH-ILD Care "Raising awareness of pulmonary hypertension associated with interstitial lung disease (or PH-ILD) alongside our advocacy partners is a critical component of our collective effort to ensure patients, caregivers and physicians feel informed and empowered," said Dr. Roger Jeffs, CEO of Liquidia. "We are grateful to join hands with phaware on this important awareness campaign, and we look forward to helping ensure this vastly underserved patient population can be properly diagnosed and treated effectively." "We are proud to support the innovative work of phaware global association and its new PH-ILD podcast initiative, which brings forward stories and expert opinions to educate and empower patients about this life-threatening and often-misdiagnosed disease," said Drew Fromkin, Chief Executive Officer of Pulmovant. "Podcasts are an excellent channel for increasing disease awareness and fostering community among patients, families, and their providers. Pulmovant is pleased to be at the forefront of this important initiative alongside some of our industry colleagues." What Listeners Can Expect: In-Depth Clinical Insights: A closer look at ongoing and upcoming clinical trials shaping the future of PH-ILD. Therapies on the Horizon: Insight into groundbreaking treatments approaching FDA approval. Expert Perspectives: Exclusive commentary from leading voices defining the next chapter in PH-ILD care. A Milestone Moment for PH-ILD Awareness "These episodes represents a pivotal moment for the PH-ILD community," said Steve Van Wormer, Co-Founder of phaware® and Executive Producer of the "I'm Aware That I'm Rare" podcast. "We are thrilled to bring together such an distinguished panel of experts to discuss how research and innovation are driving meaningful change for patients worldwide." Episodes Launch April 7th New episodes will drop every Monday on all major podcast platforms, including Spotify, Apple Podcasts, and YouTube Music. Listen, Like, and Subscribe at: . About phaware® global association phaware® global association is a nonprofit organization dedicated to raising global awareness and accelerating research for pulmonary hypertension through innovative technology. Learn more at . Media Contact: Steve Van Wormer phaware® global association [email protected] 818.395.3529 SOURCE phaware global association WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

近日，知名“变废为宝”的二手商Roivant携带着新公司Pulmovant亮相欧洲呼吸学会大会，新公司Pulmovant手握肺动脉高压药mosliciguat，是从拜耳处收购得来。 Roivant公司的战略一直以来是收购其他人不要的管线，再将其开发，此次交易也不例外，拜耳在2022年上半年放弃了处于I期临床的mosliciguat的开发，而如今Roivant以1400万美元的预付款从拜耳获得了mosliciguat的全球许可权，未来里程碑付款高达2.8亿美元，拜耳还有资格获得专利使用费。 sGC通路的开发历程 Mosliciguat，前称BAY 1237592，是一款吸入剂型可溶性鸟苷酸环化酶（sGC）激动剂，靶向的是一氧化氮（NO）-可溶性鸟苷酸环化酶（sGC）-环鸟苷酸（cGMP）途径。 这是1998年诺奖获得者Ferid Murad等三位科学家首次发现的通路，这位美国三院院士的团队最初在研究爆炸物硝化甘油为何能够治疗心脏病。他们意外发现硝化甘油释放的一氧化氮会作为信号分子刺激sGC，进而产生cGMP舒张血管。 具体而言，sGC本身是NO的受体，在接收到NO信号后，会发生构象变化，由静息状态转变为高活力激活状态，进而催化GTP生成cGMP。cGMP作为第二信使，能够激活下游的效应蛋白，如PKG（蛋白激酶G），从而调节多种生理过程，如血管舒张、神经信号传递、血小板凝集等。 在肺动脉高压和一些心血管疾病中，sGC通路受到抑制，这导致血管紧缩。因此靶向NO/sGC/cGMP途径被广泛认为是治疗心血管疾病，包括慢性心力衰竭、肺动脉高压等疾病的重要靶标。 值得一提的是，“伟哥”西地那非同样也是在这一机制背景下开发的药物（“伟哥”西地那非是一种PDE-5抑制剂，PDE-5能够降解cGMP，而抑制PDE-5有利于血管舒张），因此亲自参与“伟哥”临床的Ferid Murad可以说是“伟哥”之父。“伟哥”为代表的PDE-5抑制剂同样也可以用于肺动脉高压。 sGC激动剂药物的困境 从药物机制来看，Mosliciguat并不是非常新颖的，毕竟已经有上市药物在先。 mosliciguat的老东家拜耳正是sGC激动剂领域的研发大牛，2013年首款在美上市sGC激动剂Riociguat（利奥西呱）就是由拜耳开发的，Mosliciguat这款后续开发的吸入剂型是拜耳在诸多sGC激动剂中的尝试之一。 利奥西呱的劣势主要在于可替代性，是西地那非等PDE-5抑制剂的下位替代，临床实践中常常是患者对西地那非无反应才使用利奥西呱，而且虽然是同一通路的不同机制，但是不能一同使用，否则可能造成严重低血压。 考虑到相比之下西地那非价格也不贵，这也难怪，在商业上，利奥西呱并不算太成功，半衰期短，价格贵，又要经常服用，市场起步还晚，市场渗透率自然相对较低，增长也相对比较缓慢。 而事实上，后续业内的sGC激动剂迭代产品开发也不顺利。Cyclerion Therapeutics公司想要将praliciguat用于保留射血分数的心衰、糖尿病肾病，但是19年I期临床的概念验证就失败了。开发的另外一款分子Olinciguat在镰状细胞性贫血中的临床也宣告失败，Cyclerion Therapeutics后续打算开发中枢神经系统中的sGC激动剂Zagociguat和CY3018，不过也已经出售给了Tisento Therapeutics公司，Cyclerion Therapeutics现在是待价而沽，寻求股东价值最大化的状态。 拜耳方面，vericiguat在2021年以心衰适应症上市，但市场并不看好这一药物的未来市场前景，疗效看起来似乎不如诺华的Entresto和阿斯利康的达格列净，普遍给出的较低销售额预测。 2022年H1拜耳放弃了mosliciguat的开发，其实纵向对比Riociguat，mosliciguat已经将原本12h但半衰期提升到40h了。但横向对比，合作伙伴默沙东的肺动脉高压新药Sotatercept机制完全不相同，服药间隔长，三周一支，虽然价格贵，年治疗费用能达到24.2万美元，但效果好，市场普遍看好Sotatercept未来该是个重磅炸弹。 2024年上半年放弃了runcaciguat用于慢性肾病的开发，转而投入药效和药动更优化的BAY3283142。 和上述的开发途径相比，此次Roivant倒是另辟蹊径。 Roivant的算盘 拜耳的出售固然有拜耳新CEO上任改革的缩影，Roivant的收购也有自己的算盘。 此次Roivant表示观察到Mosliciguat能够使肺动脉高压患者的肺血管阻力（PVR）持续降低高达38%，降幅确实是史无前例的，但值得指出的是，Roivant选择的适应症是与间质性肺病（PH-ILD）相关的肺动脉高压，选择的是存在巨大未满足临床需求中的药物，而他们认为这一患者群体在欧美可能有20万人。 如果确实存在这样的一个市场，那么Roivant在这场博弈中可能确实找准了位置，未来默沙东新药Sotatercept可能会取代利奥西呱的位置，实际可能会反映在Sotatercept放量后利奥西呱的销售额变化。 Mosliciguat在这一空白市场的开发，可能为这类sGC激动剂药物找到出路。 参考来源： Friebe A, Kraehling JR, Russwurm M, Sandner P, Schmidtko A. The 10th International Conference on cGMP 2022: recent trends in cGMP research and development-meeting report. Naunyn Schmiedebergs Arch Pharmacol. 2023 Aug;396(8):1669-1686. doi: 10.1007/s00210-023-02484-8. Epub 2023 Apr 20. 周婷婷,刘潇.可溶性鸟苷酸环化酶刺激药的研究现状[J].中国临床药理学杂志,2023,39(21):3178-3182.DOI:10.13699/j.cnki.1001-6821.2023.21.029.

Pulmovant is focused on “imminently” launching a global phase 2 trial of 120 patients with PH-ILD. Matt Gline is back with a new ‘vant’ company, after the Roivant Sciences CEO paid Bayer $14 million upfront for the rights to a phase 2-ready pulmonary hypertension drug.The asset in question, mosliciguat, is an inhaled soluble guanylate cyclase activator in development for pulmonary hypertension associated with interstitial lung disease (PH-ILD). As well as the upfront fee, Roivant has agreed to hand out up to $280 million in potential milestone payments to Bayer for the exclusive worldwide rights, on top of royalties.Roivant created a new subsidiary, Pulmovant, specifically to license the drug. The latest vant also announced today data from a phase 1 trial of 38 patients with PH that showed peak reduction in pulmonary vascular resistance (PVR) of up to 38%. The biotech described these “clinically meaningful” data as “one of the highest reductions seen in PH trials to date.”The inhaled prostacyclin Tyvaso is the only drug specifically approved for PH-ILD. The selling point of mosliciguat is that unlike other inhaled PH therapies, which require multiple inhalations at various points during the day, it only needs one inhalation a day, Roivant explained in a Sept. 10 release.Pulmovant is now focused on “imminently” launching a global phase 2 of 120 patients with PH-ILD. With around 200,000 people in the U.S. and Europe living with PH-ILD, Pulmovant picked this indication “because of the lack of treatment options for patients coupled with the impressive phase 1b results and strong biologic rationale,” Pulmovant CEO Drew Fromkin said in a release. Fromkin is no stranger to getting a nascent vant off the ground, having previously served as the first CEO of Proteovant Therapeutics until it was acquired by South Korea’s SK Biopharmaceuticals last year.Fromkin said Tuesday morning that his latest vant has already assembled “a stellar team, alongside our world-class investigators and advisors, to advance and optimize mosliciguat’s development.”“Mosliciguat has the incredibly rare advantage of potential differentiation across three separate key areas—efficacy, safety and convenience in administration,” Roivant’s Gline said in a release.“We are impressed with the data generated so far, particularly the PVR results, and we believe its differentiated mechanism as an sGC activator can have maximal impact on PH-ILD patients, a large population with severe disease, high morbidity and mortality, and few treatment options,” Gline added.Gline may have found space for another vant in his stable after selling off Telavant to Roche for $7.1 billion last year, telling Fierce Biotech in January that he still had “pangs of regret” about the decision.