NATICK, Mass. — AllRock Bio, Inc., a clinical-stage biotechnology company focused on advancing impactful therapies for cardiopulmonary and fibrotic diseases, today announced the dosing of the first patients in the Phase 2a ROCSTAR trial of ROC-101, a first-in-class, oral pan-rho-associated protein kinase (ROCK) inhibitor, in pulmonary hypertension (PH). Building on Phase 1 data, the open-label, multicenter, exploratory study will evaluate the safety, tolerability, and efficacy of ROC-101 to treat patients with pulmonary arterial hypertension (PAH) or PH associated with interstitial lung disease (ILD-PH).
By inhibiting both ROCK1 and ROCK2 with high selectivity and potency, ROC-101 targets the inflammatory, proliferative, and fibrotic remodeling that occurs in PAH and ILD-PH, as well as other cardiopulmonary diseases, such as Group 2 PH and idiopathic pulmonary fibrosis. Additionally, pan-ROCK inhibition is anticipated to be highly complementary to other PH treatments, and the ROCSTAR trial is designed to evaluate ROC-101 in combination with standard of care, including a dedicated PAH arm for patients on sotatercept.
“We have successfully dosed our first patients with ROC-101, including in combination with a stable dose of sotatercept,” said Dr. Kate Steiner, MBBS, VP, Head of Clinical Development at AllRock. “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.”
As part of the ROCSTAR trial, NCT07175038, up to 30 PAH and 10 ILD-PH patients, World Health Organization (WHO) functional class II and III, will receive ROC-101 in combination with standard of care therapy. The primary endpoint is change in pulmonary vascular resistance assessed via right heart catheterization from baseline versus at week 24 post-treatment. Key secondary endpoints will include change in 6-minute walk distance, NT-proBNP, WHO functional class, and hemodynamic measures.
About ROC-101
ROC-101 is a first-in-class, oral pan-ROCK inhibitor in clinical development for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (ILD-PH). With favorable pharmacokinetics that support once-daily dosing, ROC-101 is designed to selectively and potently inhibit both ROCK1 and ROCK2. By targeting the distinct, non-redundant roles of these kinases that are central to the inflammatory, proliferative, and fibrotic remodeling seen in cardiopulmonary diseases, ROC-101 has the potential to address significant unmet needs. Its mechanism of action is anticipated to be highly complementary to other approved and investigational therapies for pulmonary hypertension. In a Phase 1 study in healthy volunteers, ROC-101 was found to be safe, well tolerated, and showed no evidence of hypotension.
About ROCSTAR
The ROCSTAR trial is AllRock Bio’s Phase 2a open-label, multicenter, exploratory clinical study investigating its lead asset, ROC-101. The trial will evaluate the safety, tolerability, and efficacy of ROC-101 in patients with pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (ILD-PH). The study is designed to explore ROC-101’s potential as a complementary therapy alongside standard-of-care treatment.
About PAH
Pulmonary arterial hypertension (PAH) is a severe condition characterized by elevated blood pressure in the pulmonary arteries, impacting both the lungs and the right side of the heart. In PAH, the small pulmonary vessels undergo progressive narrowing, leading to elevated pulmonary arterial pressure. This heightened pressure impedes blood flow through the lungs, necessitating increased effort from the right ventricle to maintain adequate circulation, ultimately placing significant strain on the heart. Despite 16 approved drugs—including four primarily vasodilator classes—there continues to exist an unmet need for disease-modifying treatments in the current landscape.
About ILD-PH
Pulmonary hypertension (PH) associated with interstitial lung disease (ILD-PH) is a distinct form of PH where the blood pressure in the lungs increases in the setting of ILD. ILD encompasses a broad group of diseases, such as idiopathic pulmonary fibrosis, that impair the structure of the lungs, making it progressively harder to breathe. ILD-PH is associated with increased mortality and morbidity with worsening symptoms over time, and very limited treatment options are available.
About AllRock Bio
AllRock Bio is a clinical-stage biotechnology company focused on the development of transformative therapies for cardiopulmonary and fibrotic diseases. The company’s lead candidate, ROC-101, is a potential first-in-class, oral pan-ROCK inhibitor being developed to address the urgent unmet need in pulmonary arterial hypertension (PAH) and other life-threatening fibrotic diseases. With a seasoned leadership team and a commitment to addressing unmet need, AllRock is dedicated to bringing a new class of disease-modifying therapies to patients. For more information, please visit www.allrockbio.com. Follow us on LinkedIn.
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