SCM Lifescience Fails to Prove Efficacy of Acute Pancreatic Therapy in Phase 1/2a Trial

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SCM Lifescience failed to prove the efficacy of its acute pancreatic therapy candidate in the nationwide Phase 1/2a clinical trial. Additionally, the company revised the clinical results disclosure the same day, causing a stir, according to industry sources.


In a public notice on Wednesday, SCM Lifescience said it failed the primary efficacy rating in the SCM-AGH 1/2a clinical trial in patients with pancreatic inflammation. acute at moderate or higher levels.


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The company defined its primary efficacy assessment variables as “CTSI (Computerized Tomography Severity Index) on the 28th day of treatment administration for the clinical trial and MMS (Modified Marshall Score) change on the seventh day of administration drugs, but failed to confirm statistical significance in the test versus placebo group in both indices.


“However, there were no serious adverse drug reactions that could affect safety, abnormal embolization-related reactions, or adverse drug reactions leading to subjects dropping out midway through the trial periods. of phases 1 and 2a,” the company said.


SCM Lifescience added that there were no reports of subject deaths during the clinical trial period related to SCM-AHG.


Regarding the disclosure of the results of the 1/2a trial results, the company also revised some of the content on the day of the publication of its public notice.


In the review, SCM Lifescience downplayed the content of the Primary Efficacy Rating Index while emphasizing the Secondary Efficacy Rating Index.


For example, the company removed the sentence: “There was a statistically significant reduction in CTSI points (CTSI p=0.0078) before and after administration of the test drug in the group in which the test was administered.” Instead, he inserted a new sentence, “Primary and secondary efficacy evaluation indices are parallel indices and primary endpoints.”


In addition, the company pointed out that it had confirmed that among the secondary indices for evaluating efficacy, the number of “CPR (C-Reactive Protein) showed a statistically significant reduction in the test group compared to the placebo group.


Despite its failure to meet key endpoints, SCM Lifescience said it “expects the immune control mechanism of SCM-AGH to function effectively in the early treatment of acute pancreatic inflammation. “, drawing attention to its future development plans and market reaction, the industry watchers said.


SCM Lifesicence obtained SCM-AGH 1/2a Investigational New Drug (IND) clinical trial approval from the Ministry of Food and Drug Safety in 2018 and conducted clinical trials in 11 national medical institutions before completing them March 15.

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