ResVita Bio Receives FDA Clearance to Advance Novel Bacterial Therapy for Rare Skin Disease

Key Insights

• ResVita Bio completed a successful Pre-IND meeting with the FDA for RVB-003, a first-in-class therapy for Netherton Syndrome, a life-threatening genetic skin disorder with no approved treatments.
• The company's innovative approach uses genetically engineered bacteria to continuously produce therapeutic proteins directly on the skin surface, overcoming limitations of conventional protein drugs.
• FDA provided positive feedback on the development program, clearing the path for IND submission in the first half of 2026 and clinical efficacy readout by early 2027.

ResVita Bio announced the successful completion of a face-to-face Pre-Investigational New Drug meeting with the U.S. Food and Drug Administration for RVB-003, its lead investigational therapy targeting Netherton Syndrome, a chronic and life-threatening genetic skin disorder. The Berkeley-based biotechnology company received positive feedback from FDA reviewers, establishing a clear regulatory pathway toward clinical trials.

Novel Therapeutic Approach for Unmet Medical Need

Netherton Syndrome is caused by mutations in the SPINK5 gene, leading to uncontrolled protease activity, chronic skin inflammation, and life-threatening barrier defects. Patients with this rare condition face high morbidity and mortality, with no FDA-approved therapies currently available.

RVB-003 represents a first-in-class KLK5/7 protease inhibitor generated through machine learning-guided protein design. The therapy has received both Orphan Drug Designation and Rare Pediatric Disease Designation for Netherton Syndrome, reflecting its potential to address this significant unmet medical need.

Continuous Protein Therapy Platform

The investigational treatment is delivered through ResVita Bio'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 innovative approach is designed to overcome the short half-life of conventional protein drugs and enable safe, sustained treatment of skin diseases.

In preclinical studies including in vitro, ex vivo, and in vivo models, RVB-003 demonstrated robust efficacy with a remarkable safety profile, improving skin barrier integrity and reducing inflammation in disease-relevant models of Netherton Syndrome.

Regulatory Pathway and Timeline

The FDA provided positive feedback on ResVita Bio's final development program, including alignment on final nonclinical studies, manufacturing, and the proposed design of the first-in-human clinical trial. With this regulatory guidance, the company has established a clear path to submit an IND for RVB-003 in the first half of 2026, leading to clinical efficacy readout by early 2027.

"We are very encouraged by the outcome of our Pre-IND meeting with the FDA," said Chad Miller, PhD, Chief Technology Officer of ResVita Bio. "The strong alignment with FDA reviewers reinforces our confidence in advancing RVB-003 to the clinic. We are excited to incorporate their feedback and move forward toward clinical trials next year for patients and families who urgently need treatment."

The development work has been supported by private investment and the National Institute of Arthritis and Musculoskeletal and Skin Diseases awards 1R43AR082240-01 and 2R44AR082240-02.