Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 65

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 65
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 manufacturing methods, scaling up processes, and preparing Nano-Mupirocin for clinical trials. The Company has already initiated the selection of a Contract Development Manufacturing Organization (CDMO) accredited for Good Manufacturing Practices (GMP). The selection criteria emphasize regulatory compliance and the CDMO’s capability for seamless technology transfer if required. This strategy ensures a smooth transition from development to manufacturing, maintaining high-quality production standards and scalability to support clinical trial batch production. The chosen CDMO will develop the production process, ensuring compliance with regulatory standards while effectively scaling up to produce clinical trial batches. The analytical methods necessary for product characterization will be developed by the selected CDMO under the close supervision of the Company’s team and experienced consultants. These methods, which will be developed and validated, are intended to assess critical attributes of the drug product, including potency, impurity levels, particle size distribution, and stability. They will form the foundation of quality control and regulatory compliance efforts. Simultaneously, bioanalytical development will focus on advanced techniques for quantifying Nano-Mupirocin and its metabolites in biological samples. Metabolite analysis, performed in collaboration with the CDMO, will provide deeper insights into the drug’s pharmacokinetics and metabolism. This dual approach ensures a thorough characterization of Nano-Mupirocin, laying the groundwork for successful clinical development and regulatory submission.

The Phase 1 activities planned to commence Q1 2026, will prepare for and execute the initial clinical study to assess the safety, tolerability, and pharmacokinetics of Nano-Mupirocin. An Investigator’s Brochure is currently being prepared to consolidate all preclinical and clinical information about the investigational product. A clinical trial synopsis and protocol document are also being developed by the Company, outlining the study’s objectives, design, endpoints, and methodologies. Regulatory submissions are planned to be made to the Ministry of Health (MOH) in Israel, while pre-Investigational New Drug (pre-IND) submissions and meetings with the FDA will be conducted to facilitate trials in the US.

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The Phase 1 clinical trial will be initiated in Israel and/or the US, depending on regulatory and logistical considerations. The study will involve healthy volunteers or patients and will evaluate the safety, tolerability, and pharmacokinetics of Nano-Mupirocin. Once the trial is complete, the data will be analyzed to assess the drug’s safety and pharmacokinetic profiles. The findings will guide the next steps in clinical development and inform strategies