ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–Enzychem Lifesciences (KOSDAQ: 183490), announced today database lock for the Phase 2 clinical trial of its lead program EC-18 in chemoradiation-induced oral mucositis (CRIOM) had been completed last August.
Enzychem will announce top-line results during October 2021. Enzychem received FDA Fast Track Designation for EC-18 in CRIOM and also plans to submit Breakthrough Therapy Designation (BTD) in 4Q 2021.
EC-18, the company’s lead investigational candidate, is a novel, first-in-class, oral immunomodulator, which facilitates rapid resolution of inflammation and early return to homeostasis.
“For patients treated with chemoradiation for head and neck cancer, oral mucositis is a debilitating side-effect which can cause treatment discontinuation,” said Dr. Stephen Sonis, a world-renowned expert in epithelial injury associated with cancer therapy and scientific advisory board member at Enzychem Lifesciences. “EC-18 has a unique mechanism of action which prevents excessive neutrophil recruitment to the inflamed sites and, thereby, lessens the severity of oral mucositis. Its oral delivery will be a much needed option for patients, as there are currently no FDA-approved therapies.”
“We are excited to achieve a major clinical milestone and look forward to reporting topline results from our Phase 2 study by 4Q 2021,” said Dohyun Cho, Ph.D., Chief Operating Officer, Enzychem Lifesciences. “There is a significant unmet medical need in CRIOM, and we look forward to advancing EC-18, a first-in-class oral therapy, to the next clinical stage with a strong global strategic collaboration for patients undergoing chemoradiation therapy.”
The Phase 2, randomized, double-blind, placebo-controlled, 2-stage study evaluated EC-18 in 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 in 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 cancer therapy and/or radiation 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.
Contacts
Investors / Business Development
Ted Kim
Director of Business Development
ted.kim@enzychem.com
Media
KKH Advisors
Kimberly Ha
kimberly.ha@kkhadvisors.com
917-291-5744