Tego Science said on Wednesday it has completed the enrollment of patients for a phase-3 clinical trial of TPX-114, an autologous cell therapy.

TPX-114 is an autologous cell therapy that treats full-thickness rotator cuff tear using the patient’s tissues. The company will secure efficacy data from the patients in the phase-3 study and submit a new drug application (NDA) to the drug regulator.

Tego Science, located in Magok in western Seoul, says it has completed recruiting patients for a phase-3 study of cell therapy TPX-114 in full-thickness rotator cuff tear.
Tego Science, located in Magok in western Seoul, says it has completed recruiting patients for a phase-3 study of cell therapy TPX-114 in full-thickness rotator cuff tear.

The treatment market for rotator cuff tear is growing rapidly amid the population aging and increasing sports activities.

According to data from the Health Insurance Review and Assessment Service (HIRA) in 2019, the domestic market was worth 600 billion won ($539.7 million). The market is expanding at least 15 percent per year. The global rotator cuff tear market is estimated to be about 13 trillion won.

“Despite tough business environment amid the Covid-19 pandemic, we have completed recruiting patients. We will fully prepare for NDA of TPX-114 to commercialize it quickly,” an official at Tego Science said.

As for another autologous cell therapy, TPX-115, which aims to treat partial-thickness rotator cuff tear, the company recruited 25 percent of the patients after starting the phase-2 local study in late January progress was faster than expected, the official said.

“The preparation for a U.S. trial is going smoothly as well,” he added.

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