Asahi Kasei Pharma starts Phase III study of CIPN prevention therapy
Previous Phase I and II studies suggest efficacy and patient tolerability of ART-123 for CIPN by suppressing the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI)
Asahi Kasei Pharma has started trial drug administration in a Phase III study of ART-123 in Japan (generic name: thrombomodulin alfa; marketed as Recomodulin Injection in Japan) for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) related symptoms. This announcement follows 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. This condition, known as CIPN, is characterised by tingling and pain in the hands and feet, which, when severe, can impair day-to-day activities. In some cases, reduced dosage or suspension of chemotherapy may be necessary to alleviate symptoms, leading to a clinical effect on the patient’s prognosis. There are currently no drugs showing clear, established 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. Previous Phase I and II studies suggest efficacy and patient tolerability of ART-123 for CIPN by suppressing the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI). After consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) 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. “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.”