Asahi Kasei Pharma has commenced patient dosing in a Phase III clinical trial evaluating ART-123 (thrombomodulin alfa) for the prevention of sensory symptoms associated with chemotherapy-induced peripheral neuropathy (CIPN) in Japan. The milestone represents a significant advancement in addressing an unmet medical need that affects cancer patients worldwide.
Addressing Critical Treatment Gap
CIPN, characterized by tingling and pain in the hands and feet, develops in patients receiving chemotherapies including platinum-based drugs, taxanes, and vinca alkaloids. When severe, this condition not only impairs daily activities but may also compromise patient prognosis due to necessary dose reductions or treatment suspension. Currently, no drugs have demonstrated clear established effectiveness for CIPN prevention or treatment, leaving patients with limited therapeutic options.
"Patients undergoing chemotherapy still have no options for preventive or therapeutic drugs with clearly demonstrated efficacy for CIPN, leaving a significant unmet medical need worldwide," said Yoshikazu Aoki, President of Asahi Kasei Pharma Corporation. "Limited treatment options for CIPN have made an already difficult situation even harder, leaving many patients and healthcare providers feeling discouraged as they seek ways to manage this challenging condition."
Phase III Study Design and Rationale
The Phase III trial will assess ART-123's efficacy for CIPN in patients diagnosed with colorectal cancer undergoing chemotherapy that includes the platinum drug oxaliplatin. The decision to advance to Phase III followed encouraging results from earlier Phase I and II studies that suggested both efficacy and tolerability of ART-123 for CIPN management.
ART-123, a recombinant human thrombomodulin approved in Japan since 2008 for treating disseminated intravascular coagulation (DIC), is thought to suppress CIPN through the activation of protein C and thrombin activatable fibrinolysis inhibitor (TAFI). The regulatory pathway was established following discussions with Japan's Pharmaceuticals and Medical Devices Agency regarding future clinical development prospects.
Clinical Development Foundation
The Phase III advancement builds upon previous clinical evidence demonstrating ART-123's potential in CIPN management. Earlier studies provided the foundation for regulatory discussions that ultimately supported the current Phase III investigation. The compound's established safety profile from its approved DIC indication provides additional clinical development advantages.
Strategic Alignment and Global Impact
The ART-123 development program aligns with Asahi Kasei's Medium-Term Management Plan, which targets high growth in the Healthcare sector with pharmaceuticals identified as a 'First Priority' area in strategic positioning. Aoki emphasized the potential global impact, stating that the company believes "ART-123 could offer a new path forward in addressing this challenge and bringing solutions for patients on a global scale."
Through its mission "to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science," Asahi Kasei Pharma aims to realize a society where "no one should have to give up doing what they love due to illness" by providing new therapeutic options that contribute to improved quality of life for patients with CIPN.
