AllRock Bio Reports Positive Phase 1 Results for First-in-Class Oral ROCK Inhibitor ROC-101 at ERS 2025

Amsterdam, The Netherlands – October 1, 2025 – AllRock Bio, Inc., a clinical-stage biotechnology company advancing therapies for cardiopulmonary and fibrotic diseases, announced encouraging Phase 1 results for its oral pan-rho-associated protein kinase (ROCK) inhibitor ROC-101 at the European Respiratory Society (ERS) Congress 2025.

The first-in-human study met its primary endpoint, demonstrating that ROC-101 is:

• Safe and well tolerated across all tested doses (up to 40 mg once daily)
• Free of hypotension risk at any dose
• Pharmacologically active, achieving target engagement with both ROCK1 and ROCK2

These findings support continued evaluation of ROC-101 in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD-PH).

Why ROC-101 Matters

• Unmet medical need: PAH and ILD-PH are life-threatening conditions with five-year survival rates of 57% and 38%, respectively. Despite 16 approved therapies, there is no widely available disease-modifying option.
• Scientific rationale: ROCK1 and ROCK2 are differentially upregulated in fibrotic and cardiopulmonary disease. Inhibiting both kinases addresses inflammation, proliferation, and fibrotic remodeling, which drive disease progression.
• Differentiation: ROC-101 achieved >20x exposure compared to fasudil, a pan-ROCK inhibitor approved in Japan and China for subarachnoid hemorrhage, at doses previously linked to survival benefit in PAH/PH trials.

Phase 1 Study Highlights

Conducted in 92 healthy volunteers, this randomized, double-blind, single and multiple ascending dose trial showed:

• Safety & tolerability:
  - No serious adverse events (AEs), discontinuations, or clinically significant ECG changes
  - Most common AEs: headache (n=2) and constipation (n=3)
• Favorable pharmacokinetics:
  - Rapid absorption and half-life supporting once-daily dosing
  - Dose-proportional increases in exposure
• Target engagement:
  - Dose-dependent inhibition of ROCK1 and ROCK2 activity.

Leadership Commentary

• Dr. William Marshall, CMO: “The results confirm that ROC-101 is a therapeutically promising compound. By targeting ROCK1 and ROCK2, we aim to deliver a more effective treatment for PAH and ILD-PH.”
• Catherine Pearce, CEO & Co-founder: “Our Phase 2a ROCSTAR trial will combine ROC-101 with standard of care to generate robust clinical data that patients and physicians urgently need.”

Next Steps

AllRock Bio plans to initiate the Phase 2a ROCSTAR trial in late 2025, evaluating ROC-101 in combination with standard therapies in PAH and ILD-PH patients.

About Pulmonary Hypertension

• Pulmonary Arterial Hypertension (PAH): Characterized by elevated pulmonary arterial pressure, narrowing of lung vessels, and progressive strain on the heart. Current treatments include vasodilators, but long-term disease control remains limited.
• Interstitial Lung Disease–Associated Pulmonary Hypertension (ILD-PH): Results from lung structure impairment (e.g., idiopathic pulmonary fibrosis). Associated with worsening symptoms, high morbidity, and limited treatment options.

About AllRock Bio

AllRock Bio, Inc. is a clinical-stage biotechnology company developing transformative therapies for cardiopulmonary and fibrotic diseases. Its lead candidate, ROC-101, is the first-in-class oral pan-ROCK inhibitor designed to selectively and potently inhibit both ROCK1 and ROCK2. With a differentiated mechanism and complementary action to existing therapies, ROC-101 aims to address urgent unmet needs in PAH, ILD-PH, and other fibrotic diseases.

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