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Tuesday, Roivant Sciences Ltd. ROIV created Pulmovant to in-license from Bayer AG BAYRY exclusive worldwide rights to develop and commercialize mosliciguat.
星期二,Roivant Sciences Ltd.ROIV创建了Pulmovant,以获得拜耳公司BAYRY的全球独家许可,开发和商业化mosliciguat。
Bayer received an upfront cash payment of ~$14 million, with up to an additional $280 million agreed upon for future development, regulatory, commercial milestone payments, and tiered high-single-digit sales-based royalties.
拜耳收到了约1400万美元的预付现金付款,另外商定了2.8亿美元用于未来开发、监管、商业里程碑付款以及基于销售额的分层高额版税。
Mosliciguat is an inhaled, once-daily sGC activator with targeted delivery to the lungs via a dry powder inhaler.
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Pulmovant presented data from the proof-of-concept Phase 1b ATMOS study during the European Respiratory Society Congress.
Pulmovant在欧洲呼吸学会大会期间提供了概念验证1b期ATMOS研究的数据。
Also Read: What’s Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
另请阅读:周一维韦克·拉马斯瓦米(VivekRamaswamy)创立的Roivant Sciences股票有什么进展?
The ATMOS Phase 1b trial assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat in participants with pulmonary hypertension aged between 18 and 80. Overall, 38 patients received mosliciguat in this study.
ATMOS 1b期临床试验评估了18至80岁肺动脉高压患者中莫西西瓜的疗效,安全性,耐受性和药代动力学。总体而言,本研究中有38名患者接受了mosliciguat治疗。
In the per-protocol set of patients (N=20), mosliciguat 1.0, 2.0, and 4.0 mg doses led to mean-max peak reductions in pulmonary vascular resistance (PVR) from baseline of -25.9%, -38.1%, and -36.3%, respectively. The company adds the “clinically meaningful” data is “one of the highest reductions seen in PH trials to date.”.
在每个方案的患者组(N=20)中,mosliciguat 1.0、2.0和4.0 mg剂量导致肺血管阻力(PVR)的平均最大峰值降低分别为-25.9%,-38.1%和-36.3%。该公司补充道,“临床上有意义的”数据是“迄今为止PH试验中最高的降低数据之一”。
The company highlights that mosliciguat is unlike other inhaled PH therapies. It requires one inhalation a day, whereas other PH therapies require multiple inhalations at various points during the day.
该公司强调,mosliciguat不同于其他吸入PH疗法。它需要每天吸入一次,而其他PH疗法需要在一天中的不同时间多次吸入。
“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,” said Matt Gline, Roivant’s CEO..
Roivant首席执行官马特·格林(Matt Gline)表示:“我们对迄今为止产生的数据印象深刻,特别是PVR结果,我们认为其作为sGC激活剂的分化机制可以对PH-ILD患者产生最大影响,因为PH-ILD患者人数众多,病情严重,发病率和死亡率高,治疗选择很少。”。。
Notably, a similar effect on PVR was observed in the pharmacodynamic analysis set (N=37), which included both responsive and non-responsive participants to inhaled nitric oxide (NO).
值得注意的是,在药效学分析组(N=37)中观察到类似的PVR效应,其中包括对吸入一氧化氮(NO)有反应和无反应的参与者。
Pulmovant will advance the clinical program to assess mosliciguat in its global Phase 2 PHocus study in patients with PH-ILD, a subgroup of Group 3 PH.
Pulmovant将在其针对PH-ILD(第3组PH的亚组)患者的全球2期PHocus研究中推进临床计划,以评估mosliciguat。
Approximately 120 patients will be enrolled in the study, starting imminently.
即将开始的这项研究将招募大约120名患者。
Price Action: ROIV stock is down 1.88% at $12.27 at the last check on Tuesday.
价格走势:周二的最后一次检查显示,ROIV股价下跌1.88%,至12.27美元。
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