Expert Interview
A Second Look: Assessing Roivant's Phase 1b ATMOS Study Results of Mosliciguat in Pulmonary Hypertension and Its Potential for PH-ILD
Ticker(s): ROIVInstitution: University of Florida
- Associate Professor of Medicine &Program Director of Pulmonary Hypertension at at University of Florida,
- Treats 20 aPAP patients.
- Investigator on the IMPALA trials; involved in various clinical trials in the fields of pulmonary hypertension, intensive care medicine and rare pulmonary diseases.
In the Phase 1b ATMOS study, mosliciguat achieved a reduction in pulmonary vascular resistance (PVR) of up to 38%, which is among the highest reductions seen in PH trials. How meaningful is this level of PVR reduction for patients with pulmonary hypertension, particularly those with PH-ILD?
Added By: ben_adminMosliciguat offers the convenience of once-daily dosing via dry powder inhaler (DPI), a significant advantage over other PH therapies that require multiple daily administrations. How important is this ease of use for patient compliance, and could it influence long-term treatment outcomes?
Added By: ben_adminMosliciguat’s sGC activator mechanism works independently of nitric oxide (NO) and heme, allowing it to retain efficacy in highly oxidative environments typical of PH. Can you elaborate on why this is a critical differentiation compared to sGC stimulators and how it might expand treatment possibilities for PH patients?
Added By: ben_adminThe ATMOS study demonstrated that mosliciguat was generally well-tolerated with low rates of treatment-emergent adverse events (TEAEs). Given the safety concerns associated with systemic vasodilators, how significant is the localized lung delivery of mosliciguat in minimizing adverse effects, and what safety considerations are most important for PH patients?
Added By: ben_adminPH-ILD affects around 200,000 patients in the U.S. and Europe, with limited treatment options available. Based on the data from ATMOS, how promising is mosliciguat as a potential therapy for PH-ILD patients, and what unmet needs could it address in this population?
Added By: ben_adminMosliciguat’s efficacy, safety, and once-daily dosing differentiate it from currently approved inhaled therapies, which often require multiple puffs several times per day. How does mosliciguat compare to existing treatments in terms of both patient convenience and therapeutic impact?
Added By: ben_adminThe upcoming Phase 2 PHocus study will enroll approximately 120 patients with PH-ILD. What are the key objectives and primary endpoints of this trial, and what data from the ATMOS study will guide its design and expected outcomes?
Added By: ben_adminRoivant has in-licensed mosliciguat from Bayer with significant milestones planned for its development. What are the regulatory and commercial prospects for mosliciguat, and how might its potential best-in-class profile shape the future of PH treatment, particularly for the underserved PH-ILD population?
Added By: ben_adminAre You Interested In These Questions?
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