Enzychem Lifesciences announced 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 fourth quarter of 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. 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. 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.