South Korea’s Celltrion Inc. has started a clinical trial of its investigational hypertrophic cardiomyopathy (HCM) drug in Poland, marking its first global step in the expansion into chemically synthesized therapeutics beyond biosimilars.

According to industry sources on Monday, the company is recruiting volunteers in Poland for a Phase 1 trial of CT-G20 with an aim of getting indication for HCM, a disease in which the heart muscle becomes abnormally thick.

Celltrion plans to receive FDA clearance of Investigational New Drug Application (IND) to commence a Phase 1 clinical trial of the drug in the U.S. Currently, three U.S. centers are arranged for participation.

CT-G20 is Celltrion’s only chemically synthesized pipeline in the clinical trial stage. The company is already conducting Phase 1 trials in Korea and signed an exclusive deal to license it out to a Japanese partner in March 2019.

A Celltrion official said the domestic trials have been conducted since 2019 and are scheduled to be completed in the first half of this year, and another milestone target is to get FDA clearance of IND and enter trials in the U.S. by the end of June.

People with HCM are at higher risk for developing cardiac arrest, heart failure and other heart-related complications as the thickened heart muscle can make it harder for the heart to pump blood.

There is no approved cure for this disease in the world, and patients rely on hypertensive or antiarrhythmic drugs to relieve symptoms such as fatigue and palpitations.

By Minu Kim

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