Enzychem Lifesciences Announces Completion of Clinical Study Report (CSR) for Phase 2 Study of EC-18 in Chemoradiation-Induced Oral Mucositis

2022-03-09

Mosedipimod辐射引起的溃疡性口腔粘膜炎合作放射疗法

Enzychem Lifesciences (KOSDAQ: 183490), a late-stage biotechnology company, announced today that the company has completed the final Clinical Study Report (CSR) for their Phase 2 study of EC-18 in Chemoradiation-induced Oral Mucositis (CRIOM), entitled “Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EC-18 in altering the severity and course of oral mucositis (OM) in subjects being treated with concomitant chemoradiation therapy for cancers of the mouth, oropharynx, hypopharynx, and nasopharynx.”

The phase 2 U.S. study was designed as 2 stages with 105 randomized subjects at 21 sites to evaluate the safety, tolerability, and efficacy of its lead compound, EC-18 on mitigating severe oral mucositis (SOM) in head and neck subjects receiving concomitant chemoradiation therapy for cancers of the mouth, oropharynx, hypopharynx, and nasopharynx.

An iDSMB evaluated the safety endpoint every two weeks in a blinded fashion, until 30 days after the last dosing of Stage 1. If a safety issue was noted, the iDSMB was instructed to unblind the treatment assignments to ascertain if the adverse event (AE) was associated with the study drug. Since no safety issues were identified at the end of Stage 1, Stage 2 commenced using 2000 mg of the study drug, consistent with a positive safety outcome.

The primary efficacy endpoint demonstrated that the median duration of SOM (defined as WHO Grades 3 or 4) from baseline through short-term follow-up period (STFU) was 0.0 days in the EC-18 group versus 13.5 days in the placebo group (100% reduction).

The secondary efficacy endpoints showed that the incidence of SOM from baseline through the active treatment period was reduced by 37.1% in the EC-18 group when compared to the placebo group (40.9% vs. 65.0%). Similarly, the incidence of SOM from baseline through the STFU period also reported a reduction by 35.0% in comparison to the placebo group (45.5% vs. 70.0%). Based on the estimated median time to onset of SOM with a confidence interval of 95% utilizing the Kaplan Meier analysis, the time of onset of SOM was 8 days longer in the EC-18 group in comparison to the placebo group (43 days vs. 51 days). Also, EC-18 showed a median delay of 11.5 days in time to the first use of opioid analgesics when compared to the placebo group (37 days vs. 25.5 days).

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