September 22, 2020 — Enzychem Lifesciences (KOSDAQ: 183490) announced that EC-18 is a prominent candidate to become the next promising blockbuster drug. EC-18 is a safe, orally available immunomodulator with a first-in-class mechanism of action. EC-18 drug substance or PLAG is a naturally found in Sika deer antler, which is fully synthesized lipid-based small molecule. The main component PLAG is not simply an immune booster or inhibitor, but has a mechanism of action called Pattern Recognition Receptor Endocytic Trafficking Accelerator (PETA), which intelligently modulates our immunity depending on the immune reaction. The investigational drug acts as anti-inflammatory when the immune system is activated.
“Enzychem Lifesciences expects EC-18 could be the first global new drug developed for areas of high unmet medical needs including COVID-19 by prevention of cytokine storm, Chemoradiation-induced Oral Mucositis, Acute Radiation Syndrome, and Radiation in Space,” said Ki Young Sohn, CEO and Chairman of Enzychem Lifesciences.
On August 6, 2020, the US Food and Drug Administration (FDA) approved the Phase 2 Clinical Study Program (IND) for EC-18, a new drug candidate for the treatment of preventing the progression of COVID-19 infection to severe pneumonia and acute respiratory distress syndrome (ARDS). Enzychem Lifesciences is the first Korean biotech company to receive FDA approval for Phase 2 clinical trials for COVID-19 treatment. Starting in October, Enzychem Lifesciences plans to recruit 60 patients both in the U.S. In South Korea, a Phase 2 clinical trial is already underway with Korean Ministry of Food and Drug (MFDS) approval with 5 open sites including: Chungbuk National University Hospital, Inha University Hospital, Incheon Medical Center, Gacheon University Gil Hospital, and Seoul Medical Center.
“We plan to apply for Emergency Use Authorization (EUA) to both U.S. FDA and Korean MFDS at the point when we confirm the safety and efficacy of EC-18 through 60 patients with pneumonia induced by COVID-19,” said Sohn. “The domestic clinical trial is expected to be completed by the end of this year, and we are anticipating that the U.S trial will take around 6-9 months from today, the completion of which would be the first half of next year,” he added.
Although remdesivir, an antiviral drug to treat severe COVID-19 patients was approved for EUA, there is still a huge unmet medical need for mild to moderate COVID-19 patients, which accounts for about 80% of the total COVID-19 patients, he added. Sohn believes that there is an urgent need to develop an immunomodulator to prevent cytokine storm, which if untreated, leads to Acute Respiratory Distress Syndrome and severe pneumonia. He emphasized that EC-18 could be an ideal immunomodulator capable of treating mild to moderate COVID-19 patients effectively.
Enzychem Lifesciences is planning to mass produce EC-18 through its wholly-owned GMP facilities in Korea. In addition, Enzychem Lifesciences is actively seeking global, strategic partners for technology licensing and collaboration, including countries such as the United States, Europe, and Japan, who are interested in developing a COVID-19 treatment.
About Enzychem Lifesciences
Enzychem Lifesciences Corp. is a global pharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic diseases, and inflammatory diseases. Founded in 1999, the company’s proprietary compound, EC-18 is the subject of two Phase 2 clinical trials for chemoradiation-induced oral mucositis and COVID-19. EC-18 acts as an immunomodulator, facilitating the resolution of inflammation and early return to homeostasis. For more information, please visit www.enzychem.com
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