Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 89

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 89
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 of antimicrobial resistance, there is an urgent need for new antibiotic treatments, such as nano-mupirocin, that can address antibiotic resistance.

Nano-mupirocin will be submitted to the U.S. Food and Drug Administration (FDA) as a 505(b)(2) New Drug Application, which relies partially on the existing data for the known active ingredient, mupirocin, from the Reference Listed Drug (Bactroban, GSK). By referring to the approved reference listed drug, Lipovation can utilize available data on mupirocin, including toxicological and efficacy data from studies not conducted by the applicant. This approach offers a significantly faster and less expensive route to approval compared to traditional development pathways, such as 505(b)(1).

Nano-mupirocin is also eligible for the FDA’s Qualified Infectious Disease Product (QIDP) designation, an incentive program created to encourage the development of antibacterial drugs for serious or life-threatening infections. This designation was introduced as part of the Generating Antibiotic Incentives Now (GAIN) Act in 2012. QIDP designation offers several benefits, including an additional five years of market exclusivity upon product approval, as well as eligibility for priority review and fast track designation.

ARB (AT1 receptor blocker) novel cancer therapy adjuvant - Regulatory Evaluation

Nano-candesartan is a liposomal formulation of the angiotensin II receptor blocker (ARB), candesartan. Candesartan is currently used as an oral medication for managing hypertension and heart failure. However, its potential extends beyond cardiovascular applications, with promising roles in cancer therapy due to its ability to modulate the tumor microenvironment (TME) and improve drug penetration. By encapsulating candesartan in nano-liposomes, the drug’s therapeutic index is enhanced, reducing systemic effects and allowing targeted release at tumor sites.

Nano-candesartan’s liposomal encapsulation protects the drug in circulation and selectively releases it in tumors, facilitating TME normalization. This normalization, in turn, enhances the effectiveness of other cancer therapies, including immune checkpoint inhibitors and chemotherapy. Given the increasing incidence of resistant cancers and the need for novel therapies, Nano-candesartan represents a new frontier in cancer treatment.

Nano-candesartan will be submitted to the U.S. Food and Drug Administration (FDA) under the 505(b)(2) New Drug Application, leveraging existing data on candesartan from the reference listed drug (Atacand). This pathway allows