IN026 is a potential first-in-class mRNA therapy for refractory gout, marking the emergence of a new category of mRNA medicines enabled by Innorna's proprietary mRNA–LNP platform.

Innorna, a clinical‑stage biotech company advancing RNA medicines, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IN026, an investigational mRNA-based therapy for refractory gout. The IND clearance enables the company to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in this currently underserved patient population.

IN026 delivers mRNA encoding urate oxidase (uricase; UOX) to the liver to enable systemic uric acid breakdown.

"Refractory gout remains a severely debilitating condition, and existing biologic treatments are limited by immunogenicity, tolerability challenges, and diminishing efficacy over time. We are proud to advance IN026 into clinical development as a potential first-in-class investigational mRNA therapeutic designed to overcome these limitations," said Michael Beckert, Chief Medical Officer of Innorna.

"We founded Innorna on the conviction that mRNA, as a new modality, can achieve what existing therapeutic approaches cannot," said Dr. Linxian Li, Founder and CEO of Innorna. "With IN026 advancing into clinical development, we are pioneering a new chapter for mRNA-based protein-replacement therapies engineered for repeated administration and long-term control of chronic diseases."