Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 83

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 83
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 similar Minimum Inhibitory Concentrations (MIC – the lowest concentration of the drug that inhibit visible growth
of a microorganism) were observed, indicating that Mupirocin remains active against bacteria while encapsulated in liposomes. However,
even if preclinical studies show promising results, there is no guarantee that such pharmaceutical candidate will demonstrate sufficient
efficacy or safety in human populations.

Additionally, Nano-Mupirocin was shown to penetrate
phagocytic cells and enhance the extermination of bacteria in vitro. Our internal data, which has not been independently verified, suggests
that our liposomal formulation has been well-tolerated in preclinical models.

The production process for Nano-Mupirocin is
well-defined and has been scaled up to approximately a 5-liter batch. There is expertise available to further scale up this process to
25 liters, based on experience with other liposomal drug products. All excipients used in our novel formulation are pharmaceutical grade
and approved for human use.

Nano-Mupirocin: Preclinical Studies Proof on Concept in Vivo

To assess the systemic therapeutic potential
of Nano-Mupirocin, a PEGylated liposomal formulation of mupirocin, multiple preclinical studies were conducted using murine and rabbit
models of infection. These studies aimed to assess pharmacokinetics (PK), biodistribution, and efficacy against multidrug-resistant bacterial
infections, notably Staphylococcus aureus, including MRSA strains.

| 1. | Murine                        
 Model – Bloodstream Infection |

A murine model of S. aureus bloodstream
infection was used, involving 9–10 week-old specific-pathogen-free C57BL/6 female mice (~20g, Envigo). Mice were intravenously
inoculated with 10⁶ CFU of S. aureus strain 6850 via the tail vein. On day 3 post-infection, mice were randomized into three
groups (Nano-Mupirocin, free mupirocin, blank liposomes), each containing 10 animals. Treatments were administered IV (50 mg/kg) on day
3 and IP on days 4 through 7. Mice were sacrificed on day 8, and bacterial loads were quantified in the liver, kidneys, and tibia via
serial dilution plating on blood agar. Nano-Mupirocin significantly reduced bacterial loads in all organs tested compared to both control
groups. Measurements also included HPL