Exclusive: Enzychem Expands U.S. Operations as it Pushes Development of Lead Asset

Less than one year after securing a toehold in the United States, Korea-based Enzychem Lifesciences hit a major milestone with its pipeline as it eyes completion of its Phase II CRIOM (Chemoradiation Induced Oral Mucositis) study, which could lead to eventual commercialization of a treatment for the serious cancer treatment by-product.

CRIOM is caused by radiation or radiotherapy and has marked adverse effects on patient quality of life and cancer therapy continuity in head and neck cancer patients. CRIOM starts as an acute inflammation of oral mucosa, tongue and pharynx and can become life threatening as a result of severe physical obstruction of food and water intake.

In February, Enzychem completed enrollment in the first stage of the Phase II trial, which evaluates the maximum tolerable dose of the company’s lead compound, EC-18. Enzychem’s EC-18 is an immune modulator driven from deer antler that has the potential to be used for a variety of indications. It is estimated that about 500,000 patients will develop clinically significant mucositis in the United States each year.

In an exclusive interview with BioSpace, Enzychem Chief Operating Officer Dohyun Cho said the company expects to finish the Phase II CRIOM study by the end of the year and could be in line to launch Phase III after that.

“We are focusing on unmet medical needs and CRIOM has no approved drugs on the market,” Cho said. “We will meet with regulatory agencies about the second part of the trial soon. We are on a good schedule so far.”

CRIOM isn’t the only focus for Enzychem’s EC-18 asset. The company is also conducting clinical trials in two other indications, Chemotherapy Induced Neutropenia (CIN) and Acute Radiation Syndrome (ARS).

CIN is a side effect of chemotherapy marked by a low white blood cell count called neutropenia, which is characterized by abnormally low levels of neutrophils in the blood. Neutrophils are a specific kind of white blood cell that help prevent and fight infections. Chemotherapy-induced neutropenia increases a patient’s risk of infection and disrupts cancer treatment.

When it comes to the third indication, ARS, Cho said the company will have to meet with officials from the U.S. Food and Drug Administration to discuss study options since that deals with radiation. He anticipated that the study will be completed under the FDA’s animal rules “because you can’t radiate people for the purpose of the study.” ARS is caused by critical exposure to radiation. The syndrome includes neutropenia, nervous system damage, and pneumonia with a high fatality rate. Because of the unmet need with ARS, Cho said Enzychem is in line for federal grant monies from the National Institutes of Health and the Biomedical Advanced Research and Development Authority.

Enzychem was awarded Fast Track Designation for EC-18 in CRIOM and Orphan Drug Designation in ARS.

In order to facilitate the clinical trial process, Enzychem launched a U.S. operation office in New Jersey last summer. Since establishing that U.S. presence, the company has focused on expanding its operations. Cho said the company has hired a number of staffers for its New Jersey offices, including a senior director. The Garden State facility currently has about 10 employees and that number is expected to grow, Cho said.

“We are working to strengthen ourselves as we build up our development programs,” Cho said.

To help support its growth plans, Cho said the company recently secured $300 million in private investments in Korea, which will be used to finance the company’s R&D efforts.

As Enzychem’s lead compound, EC-18 is integral to the growth of the company, especially here in the United States. Cho said the company is eyeing additional research opportunities for EC-18 in a few other indications, including rheumatoid arthritis, asthma and Chronic Obstructive Pulmonary Disease.

Cho said studies have shown the safety and tolerability of EC-18, and are confident that “having this compound will be a strong aspect of future growth for the company.”