Zenesel COVID-19 Treatment Begins Patient Dosing in Phase 2 Clinical Trial

[Asia Economy Reporter Lee Chun-hee] Genencell announced on the 18th that it has started patient dosing for the Phase 2 clinical trial of 'ES16001,' an oral COVID-19 treatment under development.

According to Genencell, on the 17th, COVID-19 patients hospitalized at Soonchunhyang University Bucheon Hospital and those infected within the hospital were registered as clinical trial subjects. Symptom improvement and progression to severe disease will be monitored over the next month.

This clinical trial is the Phase 2 portion of the ongoing multinational Phase 2 and 3 trials conducted by Genencell to evaluate the efficacy and safety of ES16001. ES16001 is a new drug candidate based on a novel material extracted from the leaves of the domestically native plant Dampaulsu, which Genencell is developing as a treatment for COVID-19 and herpes zoster.

Phase 2 will verify dosage and exploratory efficacy through a placebo-controlled, double-blind method involving a total of 400 participants, including about 100 in Korea and 300 in India. The trial targets mild to moderate male and female patients aged 19 and older who have tested positive for COVID-19 via polymerase chain reaction (PCR) within 4 days of confirmation. Patients will be hospitalized for 7 days of treatment, discharged, and then undergo 4 additional outpatient examinations.

In addition to Soonchunhyang University Bucheon Hospital, other domestic clinical institutions such as Catholic University Eunpyeong St. Mary's Hospital and Kyung Hee University Hospital plan to sequentially recruit patients. Genencell also intends to continuously investigate hospital-acquired infections separately from patient recruitment and register those infected as patients. Furthermore, after completing Phase 2, the company plans to proceed with a multinational Phase 3 trial targeting approximately 700 participants.

A Genencell official stated, "We plan to complete Phase 2 dosing as early as the third quarter of this year and apply for emergency use authorization within the year," adding, "However, strategies may change depending on the domestic and international COVID-19 spread and quarantine situations."

Meanwhile, although ES16001 received approval for a Phase 2a clinical trial for herpes zoster treatment ahead of the COVID-19 Phase 2 and 3 trials, it has been relatively delayed but is expected to commence soon. A Genencell official said, "Most of the clinical trial institutions have completed Institutional Review Board (IRB) approval," and "We plan to start dosing around next month."