On October 20, 2021 Enzychem Lifesciences (KOSDAQ: 183490) reported that positive Phase 2 results from a U.S. clinical trial of its lead candidate EC-18 in chemoradiation-induced oral mucositis (CRIOM). EC-18, a novel, first-in-class, small molecule oral immunomodulator, reduced the duration and incidence of severe oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation therapy (Press release, Enzychem Lifesciences, OCT 20, 2021, View Source [SID1234591606]).
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CRIOM is a painful and debilitating side effect of chemoradiation in which patients experience severe mouth ulcerations that significantly impacts everyday activities, such as eating, swallowing, and talking. The pain from severe ulcerations can prevent a patient’s intake of solid food and fluids, leading to malnutrition and dehydration that requires hospitalization. Patients with the most severe form of oral mucositis often have to discontinue or modify their cancer treatment.
"Severe CRIOM affects almost 75% of patients being treated with concomitant chemoradiation for head and neck cancers with symptoms that are so severe that they challenge a patients’ ability to tolerate optimal treatment," said Dr. Stephen Sonis, Professor, Harvard School of Dental Medicine and Key Advisor for the U.S. Phase 2 CRIOM Study. "Despite its frequency and burden it places on patients and their caregivers, there is no approved pharmaceutical intervention. The results observed with EC-18 support its continued development and offer encouragement as an effective CRIOM therapy."
"We are delighted to announce these positive results from our Phase 2 U.S. study, which confirm that EC-18 is safe and well-tolerated," said Ki-Young Sohn, CEO & Chairman, Enzychem Lifesciences. "In addition, EC-18 may have a number of key advantages, including oral route of administration and convenience of use. We are excited to advance this novel candidate into a pivotal study and will also evaluate EC-18 for other radiation-induced inflammatory diseases."
The Phase 2 U.S. study evaluated EC-18 in oral mucositis in patients with concomitant chemo-irradiation (standard fractionated Intensity-Modulated Radiation Therapy with cisplatin) for cancers of the mouth, oropharynx, hypopharynx and nasopharynx. In Stage 1 of the study, 24 subjects were randomized to receive one of three doses of EC-18 (500 mg, 1000 mg, or 2000 mg; unit dose of 500 mg) or placebo. For Stage 2 of the study, 81 patients were randomized to receive either placebo or 2000 mg of EC-18 twice-daily over a period of approximately 7 weeks.
EC-18 successfully met both its primary and secondary endpoints in terms of efficacy and safety in the Phase 2 U.S. study. Patients on EC-18 reported a reduction in the duration of severe oral mucositis (SOM) through a short-term follow-up period from 13.5 days to 0 day (100% reduction) in comparison to the placebo arm. EC-18 also reduced the incidence of SOM through completion of radiation by 37.1% in comparison to the placebo arm (65% vs. 40.9%). The incidence of SOM through a short-term follow-up period was reduced by 35.1% in comparison to the placebo arm (70% vs. 45.5%). No serious adverse events (SAE) were reported between placebo and EC-18 groups and none of the SAEs were related to EC-18. Safety was also comparable across arms with all adverse events (AEs) attributable to expected chemoradiation-related toxicity. One-year long-term follow-up for tumor outcomes is ongoing.
Based on positive Phase 2 data, Enzychem plans to file for Breakthrough Therapy Designation to the FDA later this year, and advance EC-18 into a global Phase 3 clinical program.