AllRock Bio has dosed the first patients in its Phase 2a ROCSTAR trial, evaluating ROC-101 — a potential first-in-class oral pan-rho-associated protein kinase (ROCK) inhibitor — in patients with pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease. The open-label, multicenter, exploratory study will evaluate the safety, tolerability, and efficacy of ROC-101 in both patient groups in combination with standard of care therapies, including a dedicated arm for patients already on sotatercept. It is designed to explore ROC-101’s potential as a complementary therapy alongside standard-of-care treatment.
ROC-101 targets the inflammatory, proliferative and fibrotic remodelling underlying the two conditions. The primary endpoint is change in pulmonary vascular resistance at 24 weeks, with secondary endpoints including six-minute walk distance, NT-proBNP and World Health Organisation (WHO) functional class. In a Phase 1 study, ROC-101 was found to be safe, well tolerated and showed no evidence of hypotension.