Engineered Chemicals Life Sciences, COVID-19 Treatment Candidate Fails Phase 2 Clinical Trial

[Asia Economy Reporter Kim Yuri] Engchem Life Sciences failed to prove the efficacy of its COVID-19 treatment candidate 'EC-18' in a domestic Phase 2 clinical trial.

According to the industry on the 29th, on the 27th, Engchem Life Sciences announced the results of a Phase 2 clinical trial evaluating the safety and efficacy of 'EC-18' in preventing the progression from pneumonia to severe pneumonia or acute respiratory distress syndrome in COVID-19 patients.

Engchem Life Sciences received approval from the Ministry of Food and Drug Safety in May last year for a Phase 2 clinical trial plan involving 60 patients diagnosed with COVID-19 whose lung involvement was confirmed through chest X-rays or computed tomography (CT) scans, and conducted the trial at five domestic hospitals.

The company set the primary endpoint as the "percentage (%) of mild pneumonia patients who received at least one dose of the investigational drug progressing to severe pneumonia or acute respiratory distress syndrome requiring oxygen therapy within 14 days." However, Engchem Life Sciences did not confirm statistical significance between the treatment groups.

Engchem Life Sciences explained, "Due to the exploratory nature of the clinical trial, the limited small number of participants, and the design limitation that required immediate discontinuation of the drug upon adverse events such as symptom worsening, it is analyzed that the efficacy of the investigational drug could not be properly evaluated."

The company added, "Although the investigational drug was administered orally once daily for a total of 14 days to evaluate its efficacy, there were constraints in assessing efficacy due to dropouts and treatment discontinuations caused by symptom worsening or adverse reactions."

However, the secondary endpoints, inflammatory cytokines IL-8 and IL-6, which play a key role in the pathophysiology of COVID-19 pneumonia, showed statistically significant decreases. IL-8 showed a statistically significant reduction on day 14 compared to day 1 of the trial, and IL-6 showed a statistically significant decrease on day 14 compared to day 1 in the 50-64 age group.

The National Early Warning Score (NEWS), an indicator showing improvement in patient symptoms, showed significant differences between treatment groups in some participants aged 50-64.

Most adverse reactions observed during the clinical trial were mild. The frequency of adverse reactions did not differ statistically between the treatment and control groups. Engchem Life Sciences stated, "We confirmed the potential for clinical application through further research."

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