Enzychem's COVID-19 Treatment Phase 2 Trial 'Primary Endpoint Not Met'... "Statistical Significance Confirmed for Secondary Endpoint"

[Asia Economy Reporter Chunhee Lee] The results of the domestic Phase 2 clinical trial of 'EC-18 (Mosedipimod)', a COVID-19 treatment developed by Engchem Life Sciences, have been released. Although the primary endpoint failed to demonstrate the drug's efficacy, the company plans to proceed with Phase 2b/3 clinical trials based on the statistical significance observed in the secondary endpoints.

Engchem Life Sciences announced on the 30th that it disclosed the results of the domestic Phase 2 clinical trial conducted on 63 COVID-19 patients to evaluate the safety and efficacy of EC-18, a COVID-19 treatment aimed at preventing the progression from pneumonia to severe pneumonia or acute respiratory distress syndrome (ARDS). EC-18 was previously approved for Phase 2 clinical trials in May last year, becoming the second COVID-19 treatment in Korea to receive such approval.

The primary endpoint of this trial was the probability of progression to severe pneumonia or ARDS requiring oxygen therapy within 14 days in mild pneumonia patients who received at least one dose of the investigational drug. However, no statistically significant difference was found between the treatment groups.

The company stated, "Due to the exploratory nature of the clinical trial, the limited number of participants, and the clinical design that required immediate discontinuation of dosing upon adverse events such as symptom worsening, the efficacy of the investigational drug could not be properly evaluated." Although the trial was designed for once-daily oral administration over 14 days, the actual average dosing duration was only 3.6 days, which limited the evaluation of efficacy.

Engchem Life Sciences emphasized that statistically significant reductions were observed in the secondary endpoints, inflammatory cytokines IL-8 and IL-6. IL-8 showed a statistically significant decrease at day 14 compared to day 1 of the trial with p=0.0032, and IL-6 also showed a significant reduction at day 14 in the 50-64 age group with p=0.0021.

Additionally, the National Early Warning Score (NEWS), an indicator of symptom improvement, showed significant differences between treatment groups on days 8, 11, 12, and 14 in the 50-64 age group. Compared to baseline, the treatment group showed a statistically significant average decrease compared to the placebo group.

The company also evaluated safety, stating that tolerability and safety were excellent. Most adverse events were mild compared to the placebo group, no statistically significant differences in incidence were observed between the test and control groups, and no clinically significant findings were noted in vital signs or electrocardiograms.

An Engchem Life Sciences representative said, "We expect to achieve positive results by conducting a Phase 2b/3 clinical trial targeting COVID-19 patients with recovery time as the primary endpoint," adding, "We are pursuing the development of EC-18 as an oral COVID-19 treatment through additional overseas clinical trials."

This content was produced with the assistance of AI translation services.