Sejong Medical Subsidiary Genencell Begins Patient Recruitment for Korea's First Shingles Treatment Clinical Trial

[Asia Economy Reporter Jang Hyowon] Genencell announced on the 15th that it has started recruiting patients for the Phase 2a clinical trial of its herpes zoster treatment candidate ‘ES16001’ currently under development.

Genencell completed initial meetings with medical staff and clinical research organization (CRO) representatives at Soonchunhyang University Bucheon Hospital and Korea University Ansan Hospital on the 10th and 14th, respectively, and began patient recruitment.

In addition, patient recruitment is expected to proceed sequentially soon at clinical institutions including Kyung Hee University Gangdong Hospital, Konkuk University Medical Center, Hanyang University Hospital, and National Medical Center.

While numerous clinical trials for herpes zoster prevention vaccines and postherpetic neuralgia (PHN) treatments are underway domestically, this is the first clinical trial aimed at treating herpes zoster itself.

In this trial, a total of 66 patients will be randomly assigned in a double-blind manner to two test groups and one active control group. The clinical drug will be administered orally for 7 days, followed by exploratory evaluation of efficacy and safety. Genencell plans to complete dosing within this year and enter the next phase of clinical trials in the first half of next year.

A Genencell official stated, “Existing herpes zoster treatments require long-term administration of more than 8 days, which is difficult, and many side effects have been reported. ‘ES16001’ is expected to be highly effective, allow long-term administration without side effects, and reduce the risk of recurrence and post-cure neuralgia.”

Herpes zoster cases tend to increase in summer due to weakened immunity, and recently, the incidence has also risen due to aftereffects of COVID-19, so patient recruitment for the clinical trial is expected to be smooth.

According to a survey by the National Health Insurance Service, the domestic market for herpes zoster treatments is worth approximately 130 billion KRW annually and is growing at a rate of 5.7% per year.

‘ES16001’ is a new drug candidate based on a novel material extracted from the leaves of the native Korean plant Dambalsu, jointly developed by Genencell and Kyung Hee University College of Life Sciences with support from the Ministry of Agriculture, Food and Rural Affairs. Recently, ‘ES16001’ also demonstrated exploratory efficacy as a COVID-19 treatment and is currently undergoing global Phase 2/3 clinical trials.

Among over 2,000 medicinal plants studied by Genencell, ‘ES16001’ is known to have the most outstanding antiviral efficacy and safety. Genencell received the Presidential Award at the Agricultural, Food and Science Technology Awards (2017) and the Minister of Agriculture, Food and Rural Affairs Award (2021) for developing this substance.

Meanwhile, Genencell’s largest shareholder is medical device specialist Sejong Medical, and the pharmaceuticals used in this clinical trial will be manufactured by Korea Pharma, a shareholder and production partner of Genencell.