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.
HONG KONG SAR, China and SHENZHEN, China and CAMBRIDGE, Mass., March 17, 2026 /PRNewswire/ -- Innorna, a clinical-stage biotech company advancing RNA medicines, today 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."
About Refractory Gout
Refractory or difficult-to-treat gout refers to patients who continue to experience frequent flares, progressive tophi, or cannot achieve target serum urate despite guideline-directed urate-lowering therapy, representing a population with substantial unmet medical need. In 2026, refractory gout is estimated to affect approximately 1.9 million people worldwide, representing about 3% of all gout patients.
About IN026
IN026 is an investigational mRNA-based therapy designed to treat refractory gout by delivering mRNA encoding urate oxidase (uricase; UOX) to the liver, where expressed UOX facilitates systemic uric acid breakdown. Engineered on Innorna's proprietary mRNA-lipid nanoparticle (LNP) platform for repeat administration and long-term disease control, IN026 represents a potential first-in-class approach to mRNA-based protein-replacement therapy for refractory gout and other chronic metabolic diseases.
About Innorna
Innorna is a clinical-stage biotech advancing RNA medicines by accelerating a virtuous cycle of platform and pipeline innovation-improving lives worldwide. Backed by a substantial and growing intellectual property portfolio, the company has built a proprietary, differentiated RNA delivery and engineering platform spanning a rationally designed library of over 6,000 chemically diverse ionizable lipids, targeted LNP delivery systems, and mRNA technologies. Its vertically integrated capabilities, from discovery through cGMP manufacturing, enable deep technical expertise, accelerated development, and strong capital efficiency. Innorna is advancing a robust mRNA pipeline across chronic disease therapeutics, in vivo immunotherapies, and vaccines. Innorna has raised $150 million to date and is well capitalized through key clinical milestones. The company continues to explore strategic financing and partnership opportunities to accelerate its broader programs.
Forward-Looking Statements
This press release contains forward-looking statements that are based on current expectations, estimates and projections about the Company's business and industry and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are subject to risks and uncertainties, including but not limited to changes in market conditions, regulatory developments, competition, technological changes, operational risks and other factors beyond the Company's control. Readers are cautioned not to place undue reliance on these forward-looking statements.
The Company undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances occurring after the date of this press release, except as required by applicable law.
Logo - https://mma.prnewswire.com/media/2934528/Innorna_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/innorna-announces-fda-clearance-of-ind-for-in026-advancing-mrna-based-therapies-into-chronic-metabolic-diseases-302715622.html
