SCM Life Science, Acquired a patent for the next generation of stem cell separation culture in Japan.
SCM Life Science (KOSDAQ 298060. SCM Life Science CEO Lee Byung-gun) announced on the 15th that the administration of phase 1 clinical patients of the atopic dermatitis stem cell therapy "SCM-AGH" developing has been completed.
SCM Life Science completed registration and administration of all 20 patients at six domestic institutions (Inha University Hospital, Gangdong Kyunghee University Hospital, Konkuk University Hospital, Korea University Ansan Hospital, Yonsei Severance Hospital, and Soonchunhyang University Bucheon Hospital) just eight months after approval of the drug's clinical trial plan (IND) in February this year.
This clinical trial targets patients with moderate or higher EASI (Eczema Area Severity Index) of 16 or higher and confirms their effectiveness through EASI scores at the 12th week after administration of stem cell therapy.
EASI is an index of eczema severity, and the Korean Society of Atopic Dermatitis categorizes patients with 16 or more points as moderate atopic dermatitis and 23 or more as severe atopic dermatitis.
Currently, a total of 15 patients have achieved the 12th week after administration, and results for phase 1 clinical trials are expected to be announced in December, when patients who have finished administration today reach the 12th week after the first administration.
An official from SCM Life Science added, "Despite the COVID-19 situation, clinical trials are underway smoothly so far without side effects, and by the end of this year, we will secure data for the 12th week of the last patient and start phase 2 clinical trials early next year."
Researchers and bio-industry participating
in clinical trials are paying attention to the results of phase 1 clinical
trials for atopic dermatitis of SCM-AGH. This is because if SCM-AGH
successfully completes clinical trials, patients with moderate or higher atopic
dermatitis can receive much simpler and safer treatment than existing
treatments.
Currently, Dupigent of Sanofisa, the most representative atopic dermatitis treatment, should be administered every two weeks, but SCM-AGH is considering administration once a year from 6 months. This means that the convenience of patients can be dramatically improved as the frequency of administration is drastically reduced compared to existing treatments.