Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy
Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan. Marketed domestically under the brand name Recomodulin™ Injection, ART-123 is being investigated for its potential to prevent chemotherapy-induced peripheral neuropathy (CIPN)—a debilitating side effect commonly associated with cancer treatments such as platinum-based compounds, taxanes, and vinca alkaloids.
The initiation of this large-scale study marks a significant milestone following promising results from earlier Phase I and II clinical trials conducted in Japan. These earlier trials demonstrated encouraging signs of ART-123’s ability to reduce the symptoms of CIPN without interfering with the efficacy of ongoing chemotherapy regimens. Based on those findings, and in consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Asahi Kasei Pharma is moving forward with a focused effort to evaluate the drug’s clinical utility in a broader patient population.
Addressing a Pressing Unmet Medical Need
Chemotherapy-induced peripheral neuropathy affects a substantial number of cancer patients, particularly those receiving oxaliplatin for colorectal cancer. Symptoms of CIPN typically include tingling, numbness, and shooting pain in the hands and feet—symptoms that can be severe enough to disrupt daily life. In extreme cases, the side effects force clinicians to reduce chemotherapy dosages or even halt treatment entirely, potentially compromising a patient’s overall prognosis.
Despite the prevalence and severity of CIPN, there are currently no approved drugs that have demonstrated consistent, clinically proven efficacy in preventing or treating this condition. Existing treatments are limited to symptomatic relief with mixed results and sometimes undesirable side effects. The absence of a standard therapeutic option has left both patients and healthcare providers with few tools to combat this condition effectively.
ART-123: A Novel Therapeutic Candidate
Originally approved in Japan in 2008 for disseminated intravascular coagulation, ART-123 functions by mimicking the activity of natural thrombomodulin, an endothelial cell membrane protein that modulates blood coagulation. In the context of CIPN, ART-123 is thought to exert its effects through inhibition of the activation of protein C and thrombin-activatable fibrinolysis inhibitor (TAFI), which are involved in neuroinflammatory pathways potentially implicated in nerve damage from chemotherapy.
The Phase III trial now underway is specifically targeting patients with colorectal cancer undergoing treatment with the platinum-based agent oxaliplatin, one of the key culprits in CIPN development. The study aims to rigorously evaluate both the safety and efficacy of ART-123 in preventing neuropathic symptoms, and results could form the foundation for regulatory approval both within Japan and potentially on a global scale.
A Strategic Move for Global Impact
Yoshikazu Aoki, President of Asahi Kasei Pharma, emphasized the urgency and global significance of this research in a statement accompanying the trial announcement:
“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. 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.”
Aoki’s remarks highlight the company’s broader strategic vision. The development of ART-123 aligns with Asahi Kasei’s Medium-Term Management Plan, which places the Healthcare sector—particularly pharmaceuticals—as a cornerstone of the company’s future growth. ART-123 represents a high-priority asset within this framework, reflecting the company’s commitment to innovation in areas of high unmet clinical need.
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.
