Enzychem Files for FDA Breakthrough Therapy Designation for EC-18 for the Treatment of Chemoradiation-Induced Oral Mucositis
ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE—Enzychem Lifesciences (KOSDAQ: 183490), a late-stage biotechnology company, announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of its lead investigational candidate in chemoradiation-induced oral mucositis (CRIOM). The BTD filing is based on data from the Company’s Phase 2 trial.
FDA Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
“We are very pleased to file the FDA breakthrough therapy designation for EC-18 in CRIOM, as it will enable us to work closely with FDA on our potential design of our Phase 3 program,” said Ki Young Sohn, Chairman and Chief Executive Officer of Enzychem Lifesciences. “This designation underscores a recognition of the urgent need to bring novel treatments to CRIOM patients who have a debilitating side-effect of chemoradiation therapy. As a novel, first-in-class small molecule drug, we believe that EC-18 has the potential to be an important treatment option for cancer patients undergoing chemoradiation therapy with currently no approved therapies for CRIOM.”
Phase 2, randomized, double-blind, placebo-controlled, 2-stage study evaluated EC-18 for Head and Neck Cancer patients with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx who received standard fractionated intensity-modulated radiotherapy with concomitant chemotherapy (cisplatin). For Stage 2 of the study, 80 patients were randomized into a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as the maximum tolerable dose, determined by the independent Data Safety Monitoring Board in Stage 1.
CRIOM is an acute inflammation of the oral mucosa following systemic chemoradiation therapy. It can lead to several problems, including pain, nutritional problems as a result of inability to eat and increased risk of infection due to open sores in the mucosa. The symptoms have a significant effect on the patient’s quality of life and can limit the doses and duration of cancer treatment, leading to sub-optimal treatment.
About Enzychem Lifesciences
Enzychem Lifesciences (KOSDAQ: 183490) is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic and inflammatory diseases. Founded in 1999, the company’s lead compound, EC-18 is in clinical development in Phase 2 clinical trials in chemoradiation-induced oral mucositis and COVID-19. EC-18 acts as an immunomodulator, facilitating the resolution of inflammation and early return to homeostasis. Enzychem is headquartered in South Korea, with an office in the United States. For more information, please visit www.enzychem.com.
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