SEQ_NO | 1 | Date of announcement | 2025/02/25 | Time of announcement | 22:08:17 |
Subject | Clarification regarding the media report on the exploratory clinical trial of MS20 combined with standard medications in UC meeting its primary endpoint | ||||
Date of events | 2025/02/25 | To which item it meets | paragraph 53 | ||
Statement | 1.Date of occurrence of the event:2025/02/25 2.Company name:Micorbio Co., Ltd 3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office 4.Reciprocal shareholding ratios:NA 5.Name of the reporting media:2025/02/24 The Economic daily etc. 6.Content of the report: The marketed new drug by Microbio Co., Ltd., MS-20, in combination with existing medications, significantly improves the efficacy of ulcerative colitis (UC) treatment. The primary endpoint, ”clinical remission rate, ” reached 83.3%, compared to 35.7% for existing drugs, showing an improvement of 47.6%. The results achieved statistical significance (p=0.021, Fisher’s exact test).This marks another major milestone in human clinical trials for Microbio’s ”MS-20,” following its previous success in tripling the response rate of Keytruda in late-stage lung cancer patients. This randomized, double-blind, placebo-controlled trial was conducted in four medical centers. …… rectal bleeding subscore = 0, a state that may allow patients to return to normal life. 7.Cause of occurrence: Clarify the media report per Taipei Exchange’s request 8.Countermeasures: (1)This trial is an exploratory clinical trial which is not for drug registration purposes. (2)This trial is a double-blind, placebo-controlled, randomized, exploratory clinical trial. This trial was presented during an online investor conference in December last year that it is expected to be unblinded in the first quarter of this year. According to the results of this exploratory trial,”MS20” combined with current medications has shown significant improvement in treating ulcerative colitis (UC). 9.Any other matters that need to be specified: For the company’s financial, business and other related information, please refer to the information announced by the company on the public information observatory. |