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.
Netherton syndrome (NS) is a rare genetic disease caused by loss of functional lympho-epithelial Kazal-type-related inhibitor (LEKTI, SPINK5). It was hypothesized that small-molecule inhibitors of KLK5 could replace deficient LEKTI in NS.
Netherton syndrome (NS) is caused by mutations in the serine protease inhibitor Kazal type 5 gene (SPINK5), which encodes lympho-epithelial Kazal-type-related inhibitor (LEKTI).
Azitra Inc. made its debut on the public market June 16, in the hopes of raising a relatively modest $7.5 million to enable it to fund clinical trials, manufacturing and R&D, as well as working capital and other general corporate purposes.
Quoin Pharmaceuticals Ltd.’s scientific advice briefing document is asking the EMA for ideas on how to proceed with lead asset QRX-003 for Netherton syndrome (NS).
