Early data from PHocus trial of mosliciguat expected later this year
Enrollment in US clinical study of inhaled therapy for PH-ILD now complete
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A clinical trial testing mosliciguat, an inhaled therapy for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD), has wrapped up enrollment, and in less than one year since treating the first participant.
That announcement was made by Pulmovant, the company developing the drug and sponsoring the Phase 2 PHocus study (NCT06635850), now underway at 18 sites across the U.S. Top-line results from the study are expected later this year, the developer also announced.
According to a company press release, this is “an impressive timeline” — one “representing a rapid enrollment pace in pulmonary hypertension associated with interstitial lung disease.”
“Completing enrollment of the PHocus study in less than one year from first patient dosed underscores the strong demand for new therapeutic options for patients suffering from PH-ILD,” said Drew Fromkin, CEO of Pulmovant.
PH-ILD indicates pulmonary hypertension — high blood pressure affecting the blood vessels of the lungs — in people who have interstitial lung disease, or underlying disorders that cause scarring and inflammation in the lungs.
Mosliciguat is a potential once-daily inhaled therapy that targets soluble guanylate cyclase (sGC), an enzyme that plays a key role in controlling how blood vessels widen and relax. By activating sGC directly in the lungs, mosliciguat is designed to lower blood pressure in pulmonary vessels, improve blood flow, and limit effects on the rest of the body.
According to Fromkin, “people living with PH-ILD have limited treatment options as current therapies are often poorly tolerated and require multiple doses per day, contributing to a high treatment burden.”
PHocus testing safety, effectiveness of moliciguat in over 100 adults
The PHocus study is evaluating the safety and effectiveness of mosliciguat compared with a placebo in approximately 120 adults with PH-ILD. Participants receive treatment for 24 weeks, or nearly six months. After that period, they may join an open-label extension phase, during which all patients will receive mosliciguat.
In a previous Phase 1b trial (NCT03754660) called ATMOS, a single inhaled dose of mosliciguat was well tolerated in people with other forms of pulmonary hypertension, specifically pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.
The therapy led to a mean reduction in pulmonary vascular resistance (PVR) of up to 38%, “one of the largest decreases reported in pulmonary hypertension trials to date,” according to Pulmovant. PVR measures how hard it is for the heart to pump blood through the lungs.
In addition to PHocus, mosliciguat is also being tested in another Phase 2 study, known as PHactor (NCT07333183). That study is evaluating the safety and tolerability of mosliciguat when used in combination with inhaled treprostinil, a therapy marketed in the U.S. as Tyvaso, Tyvaso DPI, and Yutrepia.
“This milestone is a remarkable achievement and a testament to the dedication of the study participants and investigators as well as the Pulmovant team’s execution,” Fromkin said. “We are deeply grateful for their collaboration in advancing mosliciguat’s development, which brings us closer to a potentially differentiated treatment for patients with PH-ILD and may also benefit patients with other conditions associated with pulmonary hypertension and pulmonary disorders more broadly.”
