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For a better future SCM Lifescience will do its best
[Key Question 5] Clinical pipeline progress
Notice
2022-11-15

Dear Shareholders,


The clinical progress as of April 26, 2022, which showed many questions and interests, is as follows.



1. Recruitment of 72 patients for moderate-severe atopic dermatitis phase 2 clinical trial expected to be completed


▶ As of April 26, 2022, patient consent was obtained from one subject at one clinical institution,

    and the subject is on a drug holiday according to the clinical study plan and is scheduled to receive the first dose on May 12.


▶ We continuously communicate and manage with the research director and the research coordinator of the relevant institution so that the subject can proceed until the final administration.


▶ In preparation for the possibility that the final administration will not take place,

    we hold regular meetings with the professor in charge of research and secure a pool of candidate participants. 



2. Clinical Pipeline Progress

 

▶ Chronic GVHD: As of April 26, 2022, the enrollment rate has reached 92% (68/74), and the first administration is scheduled for one person each on May 2 and May 9.


▶ Moderate to severe acute pancreatitis: The registration of subjects for clinical trial 2a was completed in December 2021, and the draft clinical trial result report is expected to be completed

    by the end of July 2022 according to the planned schedule. We plan to develop a 2b clinical trial protocol in the fourth quarter of 2022 and submit an IND to the Ministry of Food and Drug

    Safety to obtain approval in early 2023.


▶ Moderate to severe atopic dermatitis: One patient participating in the phase 2 clinical trial is scheduled to receive the first dose on May 12, and as soon as it is confirmed,

    the final report of phase 2 clinical trial will be completed according to the future schedule. Afterward, we plan to conduct a phase 3 clinical trial with Handok, a partner of phase 3 clinical trial.

 


As promised at the 8th regular general meeting of shareholders, if important information on the clinical pipeline is updated,

we will deliver information quickly and accurately through a notice on our website.


We sincerely thank those who believe in us and support us.

LIST