Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 113

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 113
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 activity against Staphylococcus aureus pigment formation in vitro, as indicated in Figure
1, with an IC50(IC50is defined as the concentration of a drug which inhibits half of the maximal response
of a biochemical process. In this case, inhibition of the formation of the golden pigment is the response) equal to 20 nM.

Figure 1

Figure 1: In vitro pigment
inhibition by compound ALS-4: Inhibition of staphyloxathin (the golden pigment inS. Aureus) in the presence of increasing concentrations
of ALS-4

Efficacy of ALS-4 in a MRSA Wound Infection
Mouse Model

A study conducted by a third-party
contract research organization, assessed ALS-4’s effect in the healing of open wounds infected with MRSA in a mouse model. Compared
with topical dosing of 2% Mupirocin and oral dosing of Linezolid at 100mg/kg twice a day, oral dosing of ALS-4 at 30mg/kg twice a day
showed statistically significant improvement in wound healing. Specifically, at the end of the study on Day 7, ALS-4 exhibited 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

  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-party contract research organization, in a non-lethal MRSA bacteraemia mouse model, the mice
were orally administered with different doses of ALS-4 from 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 Day 7, ALS-4 brought 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