Chinese mRNA Biotech Innorna Cleared for US Gout Trial
Innorna's IN026 uses mRNA to encode an enzyme that breaks down uric acid, representing a new category of mRNA medicines.
Innorna, a Chinese biotech based in Shenzhen, won FDA clearance to begin a Phase 1 study of IN026, an mRNA therapy for refractory gout, the company told Endpoints News in an exclusive interview.
If successful, IN026 would represent a new category of mRNA medicines — moving beyond vaccines into chronic metabolic diseases. The therapy delivers mRNA encoding urate oxidase (uricase) to the liver, where the enzyme breaks down uric acid.
Refractory gout affects approximately 1.9 million people worldwide, representing about 3% of all gout patients. Existing biologic treatments face limitations from immunogenicity and diminishing efficacy over time.
Innorna has raised $150 million to date and is backed by what it describes as a proprietary mRNA-lipid nanoparticle platform designed for repeat administration.
The company joins a growing list of Chinese biotechs bringing novel programs to the US market, at a time when regulatory speed differences between the US and China have drawn attention from FDA leadership.