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Tuesday, Roivant Sciences Ltd. (NASDAQ:ROIV) created Pulmovant to in-license from Bayer AG (OTC:BAYRY) exclusive worldwide rights to develop and commercialize 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.
Mosliciguat is an inhaled, once-daily sGC activator with targeted delivery to the lungs via a dry powder inhaler.
Pulmovant presented data from the proof-of-concept Phase 1b ATMOS study during the European Respiratory Society Congress.
Also Read: What’s Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
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.
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.”
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.
“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.
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).
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.
Approximately 120 patients will be enrolled in the study, starting imminently.
Price Action: ROIV stock is down 1.88% at $12.27 at the last check on Tuesday.
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