AllRock Bio has dosed the first patients in the Phase IIa ROCSTAR clinical trial investigating ROC-101, an oral pan-rho-associated protein kinase (ROCK) inhibitor, for pulmonary hypertension (PH).
The multi-centre, exploratory, open-label trial builds on prior Phase I data and will assess the tolerability, efficacy, and safety of the therapy in patients with pulmonary arterial hypertension (PAH) or PH associated with interstitial lung disease (ILD-PH).
By selectively inhibiting both ROCK1 and ROCK2, ROC-101 targets inflammatory, proliferative, and fibrotic remodelling linked to PAH, ILD-PH, and other cardiopulmonary conditions, including Group 2 PH and idiopathic pulmonary fibrosis.
The study will also assess the potential of pan-ROCK inhibition as a supplementary approach to current PH therapies.
It includes a dedicated PAH arm for patients receiving sotatercept in combination with ROC-101.
The trial plans to enrol up to 30 PAH and ten ILD-PH patients, World Health Organization (WHO) functional class II and III, who will each receive ROC-101 combined with standard of care therapy.
The principal endpoint is the change in pulmonary vascular resistance, measured by right heart catheterisation from baseline to week 24 following treatment.
Secondary endpoints include six-minute walk distance, NT-proBNP, WHO functional class, and haemodynamic parameters.
ROC-101 demonstrated favourable pharmacokinetics, supporting once-daily oral dosing in earlier studies. In healthy volunteers, a Phase I study showed it was safe, well-tolerated, and not associated with hypotension.
PAH is a severe condition marked by elevated blood pressure in pulmonary arteries, affecting the lungs and right side of the heart.
AllRock Bio clinical development head VP Dr Kate Steiner said: “We have successfully dosed our first patients with ROC-101, including in combination with a stable dose of sotatercept.
“We believe ROC-101, with its oral, once-daily dosing, has differentiated potential to address underlying disease mechanisms, further reduce pulmonary vascular resistance and improve functional outcomes for patients on top of existing therapies.”
“AllRock Bio begins patient dosing in Phase IIa ROCSTAR trial” was originally created and published by Hospital Management, a GlobalData owned brand.
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