drugset / Press release

TLC BioSciences to Present Late-Breaking Poster on TLC599 Structural Benefit Data at OARSI 2026 World Congress

2026-04-13 · TLC Biopharmaceuticals, Inc. · original tlcbio.com ↗

Phase 3 exploratory analysis suggests TLC599 may offer structural benefit in knee osteoarthritis — supporting its potential as a disease-modifying therapy TAIPEI, TAIWAN and SOUTH SAN FRANCISCO, CA TLC BioSciences Corp. (“TLC BioSciences”) today announced that a late-breaking abstract featuring new data from its investigational drug TLC599 has been accepted for poster presentation at the OARSI 2026 World Congress on Osteoarthritis, being held April 23–26, 2026 in West Palm Beach, Florida, USA. The poster, titled "TLC599 for Chronic Knee Osteoarthritis: Evaluation of Potential Structural Benefit Based on a Phase 3 Randomized, Placebo- and Active-Controlled Clinical Trial," presents an exploratory analysis of joint structural outcomes from TLC BioSciences' Phase 3 clinical trial. The findings build on previously reported results demonstrating that TLC599 12 mg is superior to placebo in reducing pain in patients with moderate-to-severe knee osteoarthritis (OA) over one year, with a favorable safety profile. The exploratory analysis examined changes in medial fixed joint space width (fJSW) by knee X-ray from baseline through Week 52 in patients receiving TLC599 12 mg (two injections) versus placebo. Results showed that patients treated with TLC599 experienced approximately half the degree of joint space narrowing compared to placebo-treated patients, suggesting a potential structural benefit. These results support the hypothesis that TLC599 may preserve joint structure in addition to providing meaningful symptomatic relief. These findings are particularly relevant given recent regulatory guidance from major agencies indicating that both symptomatic and structural benefit must be demonstrated for a drug to be classified as a Disease-Modifying Osteoarthritis Drug (DMOAD). TLC BioSciences believes these results provide a scientific rationale to evaluate TLC599's structural effects more definitively in future studies using X-ray or MRI. "TLC599 has already demonstrated meaningful and durable pain relief in a rigorous Phase 3 trial. These exploratory findings suggesting potential structural benefit are encouraging and open an exciting path toward evaluating TLC599 as a potential disease-modifying treatment for osteoarthritis — a significant unmet medical need," said George Yeh, Chief Executive Officer of TLC BioSciences. Presentation Details Congress: OARSI 2026 World Congress on Osteoarthritis Location: Palm Beach County Convention Center, West Palm Beach, Florida, USA Poster Title: TLC599 for Chronic Knee Osteoarthritis: Evaluation of Potential Structural Benefit Based on a Phase 3 Randomized, Placebo- and Active-Controlled Clinical Trial Poster Number: 651 Session I: Friday, April 24, 2026 | 3:30 – 4:15 PM Session II: Saturday, April 25, 2026 | 3:30 – 4:15 PM Presenting Author: C. Kent Kwoh, MD, MACR, Professor Emeritus of Medicine, The University of Arizona College of Medicine Tucson Abstract ID: 4519946

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