ResVita Bio Announces Positive FDA Pre-IND Meeting, Advancing RVB-003 Toward IND Filing for Netherton Syndrome in Early 2026

BERKELEY, Calif., Sept. 24, 2025 /PRNewswire/ -- ResVita Bio, a biotechnology company pioneering continuous protein therapy for skin diseases, today announced the successful completion of a face-to-face Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for RVB-003, its lead investigational therapy for Netherton Syndrome, a chronic and life-threatening genetic skin disorder.

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

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

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 feedback, the company has a clear path to submit an IND for RVB-003 in the first half of 2026, leading to clinical efficacy read-out 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."

About ResVita Bio
ResVita Bio is a therapeutics company based in Berkeley, California, developing continuous protein therapy for skin diseases. By harnessing genetically engineered bacteria to continuously produce therapeutic proteins directly on the skin, ResVita delivers safer, more effective treatments for patients worldwide. This work was supported by private investment and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) awards 1R43AR082240-01 and 2R44AR082240-02.

For more information, please visit www.resvitabio.com.

Contact:
Amin Zargar
510-458-2297
[email protected]

SOURCE ResVita Bio