Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 245

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 245
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 mouse model. The study utilized 5 mice per treatment group to evaluate therapeutic efficacy. Compared with topical dosing of 2% Mupirocin and oral dosing of Linezolid at 100mg/kg twice a day, oral dosing of ALS -4at 30mg/kg twice a day showed statistically significant improvement in wound healing. Specifically, at the end of the study on Day7, ALS -4exhibited 63.8% of wound closure compared with 48.4% for oral Linezolid and 43.2% for topical Mupirocin 2%. The results are further illustrated in the graph below. (Figure 2) 124 During the study period, body weight monitoring was conducted as a safety parameter. No significant adverse effects or safety concerns were observed in the ALS -4treatment group. This study was designed as a proof -of-conceptefficacy evaluation, with comprehensive toxicology assessments subsequently completed during the IND -enablingstudies phase. Figure 2 ____________ *Unpaired student’s t -test, p<0.05 Figure 2: Result of study on ALS -4’s effect in the healing of open wounds infected with MRSA in a mouse model Efficacy of ALS-4 in a Bacteraemia Mouse Model In a further round of in vivostudies, conducted by a third -partycontract research organization, in a non -lethalMRSA bacteraemia mouse model, the mice were orally administered with different doses of ALS -4from 0.3 to 30mg/kg twice a day for 7 days, compared to those who received vancomycin only group (3mg/kg of vancomycin administered intravenously) and a no treatment control group. At the conclusion of the study on Day7, ALS -4brought a statistically significant reduction in bacterial counts in major organs such as the kidneys, lungs, liver and spleen compared with the no drug control and vancomycin only groups (unpaired student’s t -test, p<0.05). This is in addition to the previous in vivoresults announced in February 2020. Body weight monitoring and histopathological evaluation of major organs were conducted as preliminary safety indicators. According to the histopathology evaluation conducted by the contract research organization, no significant differences in severity of lesions in lungs were observed in ALS -4and vancomycin groups compared to vehicle group (p > 0.05 by unpaired Student’s t -