Asahi Kasei Pharma has commenced drug administration in a Phase III clinical trial of ART-123 (generic name: thrombomodulin alfa), marketed in Japan as Recomodulin Injection, for the prevention of chemotherapy-induced peripheral neuropathy (CIPN). The trial follows promising results from earlier Phase I and II studies in Japan, which showed ART-123’s potential in alleviating CIPN symptoms without disrupting chemotherapy regimens.

CIPN is a common and often debilitating side effect of chemotherapy agents like platinum-based drugs, taxanes, and vinca alkaloids. It causes pain, tingling, and numbness in the extremities, potentially forcing dose reductions or treatment discontinuation, which can adversely impact patient outcomes. Despite its prevalence, there are currently no approved drugs that have demonstrated consistent efficacy in preventing or treating CIPN, leaving patients with limited options.

ART-123 is a recombinant human thrombomodulin (rTM) that was first approved in Japan in 2008. It is believed to suppress the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI), mechanisms associated with the development of CIPN. Based on encouraging efficacy and tolerability data, and after discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Asahi Kasei has moved forward with the Phase III trial.

This study targets colorectal cancer patients undergoing chemotherapy with oxaliplatin, a platinum-based drug known for its high risk of inducing peripheral neuropathy. The primary focus will be on evaluating the safety and efficacy of ART-123 in preventing CIPN symptoms.

“As there are no established drugs for CIPN, patients and providers are left with few viable options. ART-123 may represent a breakthrough in this area,” said Yoshikazu Aoki, president of Asahi Kasei Pharma.

This trial aligns with the company’s Medium-Term Management Plan, which prioritizes healthcare and pharmaceutical innovation as key growth drivers.