Resvita Bio Inc. has held a pre-IND meeting with the FDA for RVB-003, its lead investigational therapy for Netherton syndrome. The FDA’s feedback gives the company a pathway to submit an IND for RVB-003 in the first half of next year, with a clinical efficacy read-out anticipated by early 2027.

Resvita Bio Inc.’s RVB-003 has been awarded orphan drug designation by the FDA for the skin disorder Netherton syndrome. RVB-003 was previously granted rare pediatric disease designation.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH has awarded Resvita Bio a $2.03 million phase II Small Business Innovation Research (SBIR) grant to advance RVB-003, a novel treatment for Netherton syndrome.