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Stem Cell Therapy
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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
News of 'Forestem-AD®Inj.' approval for use for treatment purposes
02
2024.04
Kangstem Biotech's stem cell therapy for atopic dermatitis, Furestem-AD® Inj. has been approved for therapeutic use by the Korean Ministry of Food and Drug Safety.
Kangstem Biotech's stem cell therapy for atopic dermatitis, Furestem-AD® Inj. has been approved for therapeutic use by the Korean Ministry of Food and Drug Safety. Therapeutic use approval is a system that allows the use of drugs under development to provide treatment opportunities for emergency patients who are in life-threatening situations or have no alternative treatment options.
According to the KFDA, the application was submitted by Hallim University's Gangnam Sungshim Hospital to treat patients with atopic dermatitis who have not responded to existing antibody therapies. The decision to administer Furestem-AD in the medical field confirms that there is a need for a new drug and that the drug can show significant effects depending on the patient. In particular, the fact that the hospital was a Phase 3 clinical trial site also reflects the clinicians' confidence and expectations in the efficacy of Furestem-AD.
The Phase 3 study has now completed dosing 315 patients with moderate to severe chronic atopic dermatitis, and data analysis is underway. In addition, as of March, long-term follow-up showed a 67% rate of EASI50 and 50% rate of EASI75 at one year post-dose. This is higher than the long-term follow-up results from the Phase 3 study in 2019, and the EASI75 achievement rate is in line with global antibody therapies on the market, raising expectations for the Phase 3 results.
With the approval of Furestem-AD for therapeutic use, patient dosing is expected to begin in mid-April. Following dosing, patients will be monitored for disease progression.
Top-line data from the Phase 3 clinical trial of Furestem-AD are expected to be available in June, and the company plans to file for marketing authorization later this year, with product approval expected in the second half of 2025.