Enzychem Lifesciences Corp., a South Korean biotech company, is closer to penetrating overseas markets with its independently developed investigational compound EC-18 to treat oral mucositis and other oxidative stress-mediated side effects of chemotherapy and radiotherapy.

A phase II study is underway for the compound after receiving approval from the U.S. Food and Drug Administration (FDA), the company said. The company expected that once its global sale is approved, the drug would generate more than 5 trillion won ($4.4 billion) in sales. Currently, the related global market is valued at about 85 trillion won.

“We are expecting that this immune modulating drug will prevent mucositis. We successfully synthesized this molecule in 2005 and anticipate completing the development as the world’s first oral therapy sometime next year,” Sohn Ki-young, chairman and CEO of Enzychem Lifesciences, said during a recent interview with Maeil Business Newspaper.

EC-18 is designed from combination of palmitic acid found in palm trees and linoleic acid extracted from safflower seeds. Early data showed EC-18 is proven effective in treating severe immune disorders associated with side effects of chemotherapy, the company claimed.

One of the drug’s key target indications is for oral mucositis caused by the breakdown of the immune system during chemotherapy and radiotherapy. The disease causes mouth ulcers and extreme pain, making it difficult for a patient to swallow food and continue cancer treatment.

The company obtained "AA" and "A" grades for the preparation method and the immune modulating treatment technology of EC-18, respectively, from independent Korean evaluators Ecredible and Korea Enterprise Data. Patents are already registered in Korea and the U.S., the company said.

Enzychem Lifesciences is the largest company in market capitalization on the Konex, a stock exchange for small-to-medium sized companies in Korea. The company is prepping to move its stocks to the country’s secondary Kosdaq market, which is larger than the Konex, to ensure sufficient funds to finance the development of EC-18. Stocks are due to be traded on the Kosdaq market in December.

"EC-18 will be a first-in-class drug, not a generic, and contribute to promoting Korea’s pharma and biotech sector. New findings from the development process will be released through peer-reviewed professional journals,” said Sohn.

By Lee Yu-sup

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