Genexel Begins Patient Recruitment for Clinical Trial of COVID-19 Treatment 'ES16001'

Soonchunhyang University Bucheon Hospital Launches... Global Clinical Standards Coordination Completed

[Asia Economy Reporter Lee Gwan-ju] Genensel announced on the 29th that it has started recruiting patients for clinical trials of its COVID-19 treatment candidate substance 'ES16001.' This comes six months after receiving approval for the domestic phase 2 and 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety last October.

On the same day, Genensel completed the clinical trial initiation meeting with medical staff and clinical research organization (CRO) representatives at Soonchunhyang University Bucheon Hospital and began patient recruitment. Patient recruitment will also be sequentially conducted at other clinical institutions, including the Catholic University Eunpyeong St. Mary's Hospital and Kyung Hee University Hospital.

This clinical trial will be conducted as a multinational (global clinical) study. Genensel has been coordinating clinical standards simultaneously with health authorities in Korea, Europe, and India, and recently completed all these arrangements.

A Genensel official stated, "Compared to when the clinical design was made, the number of patients has significantly increased, so recruitment is expected to proceed smoothly," adding, "Since it has been confirmed to be effective against variant viruses as well, we anticipate positive results."

They continued, "Compared to overseas treatments, it has fewer side effects and competitive pricing, so it has high market potential not only now but also after becoming endemic. Recently, we signed a business agreement for the transfer of sales rights with a pharmaceutical company in the United Arab Emirates (UAE) covering Turkey and the Middle East region, showing great interest in pre-purchase and technology transfer in Asia," they added.

Meanwhile, Genensel signed a main contract on the same day with Jeju Goyang Busamsung Foundation for the use of approximately 1.05 million square meters (about 320,000 pyeong) of land in Songdang-ri, Gujwa-eup, Jeju City, to establish a pharmaceutical raw material cultivation complex.

'ES16001' is a new drug candidate substance based on a novel material extracted from the leaves of the domestically native plant, Dambalsu.