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 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. This condition, known as CIPN, is characterized 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 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.”

This is in line with Asahi Kasei’s Medium-Term Management Plan, which targets high growth in the Healthcare sector with pharmaceuticals identified as a ‘First Priority’ area in its strategic positioning.

About Asahi Kasei Pharma

Asahi Kasei Pharma is a specialty pharmaceutical firm with a global presence focusing on the development of new world-class drugs in the areas of pain management, musculoskeletal disorders, and critical care medicine. Through its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science,” Asahi Kasei Pharma delivers innovative pharmaceutical solutions that improve health and enhance quality of life.

For more information, visit: https://www.asahi-kasei.co.jp/pharma/en/

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Healthcare, Homes, and Material. For more information, visit www.asahi-kasei.com.

Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.

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