Kangstem Biotech to launch stem cell-based atopy treatment by 2023

Kangstem Biotech, a stem cell therapy provider, plans to develop the world's first stem cell treatment that fundamentally treats atopic dermatitis with a single dose.

Kangstem Biotech CEO Na Jong-chun explains his company’s plans to conduct an additional phase 3 clinical trial for FureStem AD during a news conference at Fairmont Ambassador Seoul Hotel on Tuesday.

"We received approval for new phase 3 clinical trials for FureStem AD from the Ministry of Food and Drug Safety in May and will start recruiting and administering patients from July." Kangstem Biotech CEO Na Jong-chun said during a media briefing on Tuesday.

To obtain successful clinical results, the company has come up with a solid clinical design after consulting with experts and enlisted the help of various multinational development experts, Na added.

He went on to say that Kangstem Biotech will conduct an additional phase 3 clinical trial to make up for unsatisfactory results in the initial phase 3 clinical study regarding FureStem AD's efficacy in October 2018.

Na cited the lack of experience, the decrease in cellular activity according to the time delay from the release of the treatment to the administration, the loose control of concomitant drugs, and a lack of conducting and managing clinical trials as clinical factors behind the unsuccessful initial phase 3 study. “We have since undergone a meticulous clinical redesign process through in-depth analysis of the cause of the failure.”

Bae Yo-han, head of the company’s clinical development team, said, "For the second phase 3 clinical trial study of FureStem AD, named FURIN, the company raised the possibility of success by increasing expertise by hiring more manpower, maintaining the cellular functions of clinical trial drugs at its best and introducing patient-centered clinical trial designs.

Bae pointed out that the new phase 3 clinical trial will involve 308 patients receiving treatment at 17 institutions, 1.5 times more than 197 patients receiving treatment at 11 institutions in the previous phase 3 clinical trial.

The company will also apply a one-stop platform called SELAFTM, which optimizes stem cell separation and production to clinical trials SELAFTM.

"We plan to recruit patients in a short time and complete phase 3 clinical trials by the fourth quarter of next year," Bae said. "We plan to apply for product approval after completing the clinical trial report by the second quarter of 2023 and expect to win the nod as early as the fourth quarter.”,

CEO Na said, "We are confident that we will draw data with significant significance in the new phase 3 clinical trial of FureStem AD."

The company also unveiled other pipeline plans, including FureStem RA, a treatment for rheumatoid arthritis, and FureStem OA Kit, a treatment for osteoarthritis.