US therapeutics company ResVita Bio announced on Thursday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to RVB-003 for the treatment of Netherton Syndrome, a chronic and life-threatening skin disorder.

This development follows the FDA's previous granting of Rare Pediatric Disease Designation.

ResVita Bio said that the ODD decision underscores the impact of its new platform for continuous protein therapy -- a groundbreaking therapeutic approach designed to deliver sustained drug levels directly to the skin, supporting both greater efficacy and improved safety over other topicals.

RVB-003 is based on ResVita Bio's continuous protein therapy platform, utilising genetically engineered bacteria applied topically. This novel approach aims to address the short lifespan of therapeutic proteins by continuously producing them directly on the skin surface, thereby enhancing efficacy and safety profiles. In its ODD submission, ResVita Bio presented the in vitro, ex vivo and in vivo studies demonstrating RVB-003's treatment of Netherton Syndrome.

Dr. Amin Zargar, ResVita Bio CEO, said: "This is an exciting development for our treatment of Netherton Syndrome. Coming off our successful FDA INTERACT meeting, we're eager to discuss our finalised Drug Product with the FDA in a Pre-IND meeting during the summer. This Orphan Designation will enable increased communication throughout development, and we are excited to for clinical trials next year."