Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 80

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 80
---
 topical use in the U.S. for many years—our internal
data which has not been independently verified suggests that the 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 developed by Prof. Barenholz, including Doxil. All excipients used
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 demonstrate safety, 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 metastatic 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 HPLC quantification of mupirocin in tissues and serum IL-6 levels, which were significantly lower
in Nano-Mupirocin-treated animals, indicating reduced systemic inflammation.

<div align='center'>48</div>

Below representative figures from the bloodstream infection animal
model experiment

Fig. 1. Superior therapeutic efficacy Nano-mupirocin over the free drug after parenteral administration in a murine model of