Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy

Asahi Kasei Pharma has started trial drug administration in a Phase III study of ART-123 in Japan for the prevention of chemotherapy-induced peripheral neuropathy related symptoms. This announcement follows encouraging data from earlier Phase I and II studies performed in Japan on the efficacy of ART-123 in relieving patient symptoms without compromising existing treatment plans. 

Chemotherapies such as platinum-based drugs, taxanes, and vinca alkaloids are known to induce peripheral neuropathy. CIPN is characterized by tingling and pain in the hands and feet, which, when severe, can impair day-to-day activities. There are currently no drugs showing clear, effectiveness for the prevention or treatment of CIPN, leaving patients with limited, often undesirable options. 

ART-123 is a recombinant human thrombomodulin (rTM) approved in Japan in 2008. After consultation with Japan’s Pharmaceuticals and Medical Devices Agency regarding potential clinical development, Asahi Kasei Pharma initiated the Phase III study. The study will assess the efficacy and safety of ART-123 for CIPN in patients diagnosed with colorectal cancer and undergoing chemotherapy including the platinum drug oxaliplatin. 

“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, 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. We believe ART-123 could offer a new path forward in addressing this challenge and bringing solutions for patients on a global scale.