FDA Phase 2 Approval for Lead Candidate Based on Proprietary Drug Development Platform 'RuCIA', Entering Full-Scale Clinical Trials in the US
RudaCure Inc. (CEO Yongho Kim), a bio-pharmaceutical development company specializing in sensory disorder treatments, announced that it has obtained U.S. FDA Phase 2 Investigational New Drug (IND) approval for its dry eye disease treatment 'RCI001' on the 24th.
RCI001 is a novel drug candidate developed using RudaCure's proprietary AI-based drug development platform 'RuCIA (RudaCure Intelligence for Advanced Drug Development).' It has a mechanism of action that suppresses TRPV1 downstream signal-mediated inflammatory activation and is differentiated from existing treatments by its powerful anti-inflammatory and antioxidant effects.
RudaCure developed RCI001 through the 'RuCIA' platform, which combines protein structure analysis, molecular dynamics simulation, and AI-based drug design. The company obtained U.S. FDA Phase 2 IND approval within 5 months of completing Phase 1 clinical trials, demonstrating the efficiency and innovation of this platform. It is noteworthy that RuCIA achieved this without relying on 'big data AI' requiring massive datasets, instead proving its capability for innovative new drug development through a 'small data AI' approach combining structural biology-based simulation with machine learning.
Key results from Phase 1 clinical trials (conducted on 32 subjects at Chungnam National University Hospital under PI Park Cheol-young) showed no drug-related adverse effects or abnormal findings in vital signs, electrocardiogram, or clinical laboratory tests. Additionally, optimized formulation stability and ocular administration suitability were confirmed. While the company's own Phase 1 results are not publicly disclosed as it is a listed company and in an unlisted investment stage, when combined with the Hanlim Pharmaceutical-conducted investigator-initiated clinical trial results (published), it was confirmed that both signs and symptoms (tear volume increase + corneal damage recovery) improved simultaneously, with therapeutic effects appearing rapidly within 4 weeks and no side effects of stinging, burning, or redness upon instillation.
RudaCure plans to proceed with Phase 2 clinical trials at major medical institutions in the US within 2025, and is simultaneously designing Korea's Phase 2 clinical trials with plans to begin in the first half of 2026. The company is also pursuing global expansion based on RCI001's clinical data, including partnering with Thea (France), Santen (Japan), and other global ophthalmic pharmaceutical companies for licensing and co-development, targeting the global dry eye treatment market projected to exceed $8 billion.
CEO Yongho Kim stated, "The FDA Phase 2 IND approval signifies that RCI001 has been recognized as a candidate with clear potential for innovative new drug development, and it is a starting point for full-scale clinical trials in the US." He added, "Building on these results, we will accelerate global clinical trials and technology transfer to provide a new treatment paradigm for the approximately 350 million dry eye patients worldwide."
