Roivant and Pulmovant to Present Phase 2 PHocus Data for Mosliciguat in PH-ILD at ERS 2026
核心洞察
Roivant (搜索) and Pulmovant (搜索) will present topline Phase 2 PHocus results for inhaled mosliciguat in pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD) on Tuesday, September 8, 2026.
The randomized, double-blind, placebo-controlled global trial enrolled 135 adults, with the key endpoint being change from baseline in pulmonary vascular resistance over 24 weeks.
Mosliciguat is a potential first-in-class, once-daily inhaled sGC activator that works independently of heme and nitric oxide, differentiating it from existing prostacyclin-pathway therapy.
Roivant (搜索) and its subsidiary Pulmovant (搜索) will unveil topline results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD) on Tuesday, September 8, 2026. Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension, will present the data at 12:15 CEST (6:15 a.m. ET) at the European Respiratory Society (ERS) International Congress 2026 in Basel. Roivant and Pulmovant will host an investor call the same day.
The readout covers 135 patients' worth of Phase 2 data, with the number that matters most being how much mosliciguat moved pulmonary vascular resistance (PVR) over 24 weeks of blinded treatment. PH-ILD is a condition where approved options remain limited, and the one that exists—inhaled treprostinil (Tyvaso, approved April 2021)—works through prostacyclin pathways. Mosliciguat takes a different route entirely.
A Differentiated Mechanism of Action
That mechanistic difference is the scientific bet worth watching. Rather than stimulating native soluble guanylate cyclase (搜索) (sGC) the way sGC stimulators do, mosliciguat directly activates the heme-free, nitric-oxide-unresponsive form of the enzyme—the form that accumulates in damaged, oxidized tissue. The rationale is that PH-ILD lungs may be precisely the environment where that form predominates, which makes the drug potentially relevant where other sGC-targeting agents cannot act.
Pulmovant (搜索) describes mosliciguat as 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. The drug 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 believed to work independently of heme and NO.
The PHocus Study Design
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. All participants were eligible to receive mosliciguat in the open-label extension after the 24-week controlled period. That extension will eventually inform longer-term safety, but Tuesday's readout covers the controlled period and will define whether Pulmovant (搜索) has a drug worth advancing to Phase 3.
The single number to watch when the data drop is the change from baseline in pulmonary vascular resistance in the mosliciguat arm versus placebo. That endpoint drove the pivotal program for Tyvaso in PH-ILD and remains the hemodynamic anchor regulators and pulmonologists use to judge whether a new agent does meaningful work in this population.
Prior Clinical Evidence
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 of up to 38%, one of the highest reductions seen in pulmonary hypertension trials to date. Whether that biology translates into a measurable hemodynamic signal in the PHocus population is what the new data will answer.
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.
Disease Burden and Unmet Need
Pulmonary hypertension 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.