Chelmsford, Mass– Asahi Kasei Pharma has initiated a Phase III clinical trial in Japan to evaluate the effectiveness of ART-123 (thrombomodulin alfa), marketed as Recomodulin™, for preventing chemotherapy-induced peripheral neuropathy (CIPN). The launch follows promising results from earlier Phase I and II studies showing the drug’s potential to ease neuropathic symptoms without interfering with cancer treatment.
CIPN is a common and debilitating side effect of several widely used chemotherapy agents—including platinum-based drugs, taxanes, and vinca alkaloids—causing pain, numbness, and tingling in the hands and feet. In severe cases, patients may need to reduce or discontinue their chemotherapy, potentially compromising treatment outcomes. Despite its prevalence, CIPN currently lacks any approved, clearly effective preventive or therapeutic drug options.
ART-123, a recombinant human thrombomodulin (rTM) originally approved in Japan in 2008 for other indications, is now being tested specifically for CIPN. The drug works by modulating the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI), mechanisms thought to play a role in nerve inflammation and damage during chemotherapy.
The Phase III study, launched after discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), will evaluate ART-123 in colorectal cancer patients undergoing chemotherapy with oxaliplatin, a platinum-based drug known for causing neuropathy.
“There remains a critical unmet need for effective CIPN therapies,” said Yoshikazu Aoki, President of Asahi Kasei Pharma. “The lack of preventive treatments has left patients and healthcare providers with limited and often frustrating options. We believe ART-123 has the potential to change that.”
The study aligns with Asahi Kasei’s Medium-Term Management Plan, which prioritizes healthcare—particularly pharmaceuticals—as a key growth area. With ART-123, the company hopes to offer a new global solution for patients affected by the often-overlooked complications of cancer therapy.
