#USA #Natick #AllRock Bio #ROC-101 #ERS Congress

AllRock Bio Presents Phase 1 Data for ROC-101 at ERS Congress

At the recent European Respiratory Society (ERS) Congress held in Amsterdam from September 27 to October 1, 2025, AllRock Bio, a clinical stage biotechnology firm, revealed promising Phase 1 study results for their lead compound, ROC-101. This first-in-class oral pan-rho-associated protein kinase (ROCK) inhibitor aims to tackle cardiopulmonary and fibrotic diseases, specifically pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD-PH).

The Phase 1 trial achieved its primary objective, demonstrating that ROC-101 is safe and well-tolerated among 92 healthy participants. Notably, there were no reports of hypotension, which is a common concern with many therapeutic options. William Marshall, MD, Chief Medical Officer of AllRock Bio, expressed his enthusiasm, stating, "The results from our Phase 1 trial confirm that ROC-101 is a therapeutically promising compound."

The drug operates by inhibiting both ROCK1 and ROCK2, kinases central to the pathogenesis of fibrotic diseases. Given that PAH and ILD-PH both exhibit poor survival rates—approximately 57% and 38% over five years, respectively—addressing these conditions is critical. The unique mechanism of ROC-101 positions it to potentially offer significant therapeutic benefits by targeting the inflammatory and fibrotic processes involved.

The study confirmed several key findings:

• - Strong Safety and Tolerability: ROC-101 was recorded as safe across all administered doses, which included up to 40 mg once daily. Side effects were minimal, with only a few cases of headaches and constipation.
• - Favorable Pharmacokinetics: The drug showed rapid absorption and a suitable half-life for once-daily dosing, a crucial factor for patient compliance.
• - Effective Target Engagement: Biomarker evaluations revealed significant reductions in ROCK1 and ROCK2 activity in a dose-dependent manner.
• - Comparative Exposure Rates: ROC-101 exhibited over 20 times the exposure levels compared to fasudil, an existing pan-ROCK inhibitor used in similar contexts.

Future Direction

AllRock Bio plans to advance ROC-101 into a Phase 2 clinical trial, named ROCSTAR, focusing on its efficacy in combination with standard care therapies in PAH and ILD-PH patients. This trial is set to commence in late 2025, providing vital data that may inform treatment protocols moving forward. Catherine Pearce, CEO and co-founder of AllRock, emphasized the significance of designing trials that meet the needs of clinicians and patients alike, reinforcing their commitment to addressing the critical unmet needs in pulmonary healthcare.

Understanding PAH and ILD-PH

Pulmonary arterial hypertension is characterized by elevated blood pressure within the pulmonary arteries, creating considerable strain on the right side of the heart and limiting airflow to the lungs. Meanwhile, ILD-PH arises in conjunction with various forms of lung disease, further complicating patient outcomes and care.

With numerous therapeutics available, the urgent need for disease-modifying treatments in the PAH landscape remains high. ROC-101 represents a potential new frontier in this field, poised to make a significant impact on patient quality of life and survival rates.

AllRock Bio is dedicated to innovating therapies that respond to these demands. With a strong leadership team and a focus on unmet medical needs, they are committed to delivering transformative therapies for patients with severe cardiopulmonary disorders. To stay informed about further developments from AllRock Bio, visit their website at www.allrockbio.com.