Three Phase 1 studies support once-daily inhaled administration of mosliciguat with no evidence of serious systemic side effects

Results informed the ongoing Phase 2 PHocus study of mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)

WALTHAM, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company dedicated to developing innovative therapies to transform the treatment paradigm for adults suffering from pulmonary diseases and a Roivant (NASDAQ:ROIV) company, today announced the publication of Phase 1 pharmacokinetics (PK) in healthy male volunteers following the administration of mosliciguat, a potential first-in-class, inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs and once-daily administration, designed to provide a treatment option for patients with pulmonary hypertension (PH). The peer-reviewed manuscript titled, "Pharmacokinetics and Lung Deposition After Administration of Inhaled Mosliciguat (BAY 1237592): Results from Randomized Phase I Studies in Healthy Men," was published in the scientific journal Clinical Pharmacokinetics. These data suggest inhaled mosliciguat has a longer half-life compared to oral and IV administration, supporting further evaluation of once-daily dosing and the potential to have limited systemic side effects when administered to patients.

"We are very pleased to announce the publication of Phase 1 PK data in Clinical Pharmacokinetics, which support once daily administration of inhaled mosliciguat and its continued development for the treatment of patients with pulmonary hypertension," said Ubaldo Martin M.D., FCCP, Pulmovant's Senior Vice President and Head of Clinical Development. "Mosliciguat is the first sGC activator designed for dry powder inhalation, and these PK results from completed studies indicate that mosliciguat achieves measurable, effective systemic exposure via inhalation with no evidence of serious side effects reported to date. We are evaluating this potential first-in-class treatment in our Phase 2 PHocus study for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a severe disease with high morbidity and mortality and limited treatment options."

The safety and efficacy of mosliciguat in adult patients with PH-ILD are currently being evaluated in the Phase 2 PHocus study (NCT06635850). Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production leading to increased vasodilation, reduced inflammation and apoptosis, reverse vascular remodeling, and anti-fibrotic effects. Unlike sGC stimulators, which require reduced heme and NO to exert their effect on sGC, mosliciguat is an sGC activator that works independently of heme and NO.

The published manuscript outlines three Phase 1 studies conducted in healthy male volunteers, which characterize the pharmacokinetic profile of mosliciguat after inhalation with a low-resistance device in a lactose carrier-based dry powder formulation. In all three studies, mosliciguat was well tolerated without major systemic effects on heart rate or blood pressure. The data also suggest a long residence time in the lungs and a slow, continuous release of mosliciguat into the systemic circulation. These data provide evidence that mosliciguat, at the tested doses, is appropriate for further evaluation as an inhaled therapy.

The full text of the publication can be accessed here.

About Pulmonary Hypertension and Interstitial Lung Disease

Pulmonary 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 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 U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options. Click here for more information.

About Pulmovant

Pulmovant is a clinical-stage biotechnology company dedicated to developing innovative therapies to transform the treatment paradigm for adults suffering from pulmonary diseases. Pulmovant's first program, mosliciguat, is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension. Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism currently being investigated in a global Phase 2 trial in PH-ILD.

For more information, please visit https://www.pulmovant.com.

About Roivant

Roivant (NASDAQ:ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies 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. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com.

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Contact

Carlos Sanmarco

+1-617-803-0496

carlos.sanmarco@pulmovant.com