March 28, 2022
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma announces that study drug administration has begun for the first patient in the Japan-US international phase 1 study of ART-123 (generic name: thrombomodulin alfa; marketed as Recomodulin™ Injection in Japan)¹⁾ for the prevention of sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) being performed jointly with Veloxis Pharmaceuticals, Inc., wholly owned subsidiary of Asahi Kasei Corp. (SENSEible mCRC Study,²⁾ hereinafter “the Study”).

Chemotherapies such as platinum-based drugs, taxanes, and vinca alkaloids are known to induce peripheral neuropathy. If this condition known as CIPN, characterized by tingling and pain in the hands and feet, becomes severe, it not only impairs day-to-day activities but may also lead to a clinical effect on the patient’s prognosis due to reduced dosage or suspension of chemotherapy administration. However, there are currently no drugs showing clear established effectiveness for the prevention or treatment of CIPN.

A phase 2a study performed in Japan suggests efficacy and tolerability of ART-123 for CIPN.³⁾ Based on the result of that study, a decision to perform the Study was made as a result of discussions with the regulatory authorities of Japan and the US regarding future prospects for clinical development. The Study will assess the safety and tolerability of ART-123 for CIPN in patients diagnosed with distant metastatic colorectal cancer and undergoing chemotherapy including the platinum drug oxaliplatin. Asahi Kasei Pharma hopes to contribute to improved quality of life for patients by providing a new drug for CIPN based on its vision that no one should have to give up doing what they love due to illness.

• ¹⁾A recombinant human thrombomodulin approved in Japan since 2008 for the treatment of disseminated intravascular coagulation (DIC), ART-123 is thought to suppress CIPN through the activation of protein C and thrombin activatable fibrinolysis inhibitor (TAFI)
• ²⁾Click here for more information about the SENSEible mCRC Study

  https://clinicaltrials.gov/ct2/show/NCT05251727?term=ART-123&draw=2&rank=1

• ³⁾Kotaka, M., Saito, Y., Kato, T. et al. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol 86, 607–618 (2020).

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