ResVita Bio, a biotechnology company pioneering continuous protein therapy for skin diseases, announced on Wednesday that it has completed a face-to-face Pre-Investigational New Drug (Pre-IND) meeting with the US Food and Drug Administration (FDA) for RVB-003, its lead investigational therapy for Netherton Syndrome, a chronic and life-threatening genetic skin disorder.

RVB-003 has received both Orphan Drug Designation and Rare Pediatric Disease Designation for Netherton Syndrome. The therapy produces a first-in-class KLK5/7 protease inhibitor generated via machine learning-guided protein design.

RVB-003 is delivered via the company's proprietary continuous protein therapy platform, which uses genetically engineered, non-pathogenic bacteria applied topically to produce therapeutic proteins directly at the skin surface. This approach is designed to overcome the short half-life of conventional protein drugs and allow safe, sustained treatment of skin diseases.

According to ResVita Bio, in preclinical studies the product demonstrated robust efficacy with a remarkable safety profile, improving skin barrier integrity and decreasing inflammation in disease-relevant models of Netherton Syndrome.

The FDA offered positive feedback on the company's final development programme, which includes alignment on final nonclinical studies, manufacturing, and the proposed design of the first-in-human clinical trial. The company aims to submit an IND for the product in the first half of 2026.