Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 62

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 62
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gram/news/drug-resistant-enteric-fever-has-risen-53-percent-since-1990-gram-study-estimates |

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The nano-liposomal formulation of Mupirocin is enhanced by adding hydroxypropyl-beta-cyclodextrin (HPCD) to the intraliposomal volume, allowing for Mupirocin controlled release from the liposomes in serum. The novel Nano-Mupirocin’s efficacy has been demonstrated in various animal models with two studies sponsored by the National Institute of Health (US). Its pharmacokinetic profile in animal studies showed significantly higher exposure compared to the free drug, along with a substantially prolonged half-life. The in vitrospectrum of activity for both Mupirocin and Nano-Mupirocin was tested on many clinical isolates, showing no cross-resistance with other antibiotics. Interestingly, similar MICs were observed, indicating that Mupirocin remains active against bacteria while encapsulated in liposomes.

Additionally, Nano-Mupirocin was shown to penetrate phagocytic cells and enhance the killing of engulfed bacteria. Toxicity studies in mice, rats, dogs, and monkeys post-injection confirmed its safety. Toxicity studies in rats indicated an excellent safety profile for Nano-Mupirocin, with the highest tested dose (100 mg/kg/day) identified as the No Observed Adverse Effect Level (NOAEL).

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.

Substantial pre-clinical research of the novel Nanoparticles-based Mupirocin formulation has proven that this novel approach may allow for a new potent therapy to combat bacteria listed as serious and urgent threats by the CDC, with a safe profile and a well-defined production process. The novel formulation of nanoparticles-based Mupirocin is expected to establish Mupirocin as a highly-potent systemic drug that can be used for such life-threatening infections, such as endocarditis, osteomyelitis, or sepsis often caused by multidrug-resistant bacteria.

Novel Nanoparticles-based formulation of Mupirocin offers several key advantages, including:

| ● | Proven                                                                                               
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