drugset / Press release

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

2026-04-27 · TLC Biopharmaceuticals, Inc. · original tlcbio.com ↗

Exploratory Phase 3 data suggest TLC599 may slow joint structural progression, supporting its potential as a disease-modifying osteoarthritis therapy TLC BioSciences Corp. ("TLC") today presented new data from its Phase 3 clinical trial of TLC599 at the OARSI 2026 World Congress on Osteoarthritis, held April 23–26, 2026 in West Palm Beach, Florida, USA. The late-breaking poster (Poster #651), titled "TLC599 for Chronic Knee Osteoarthritis: Evaluation of Potential Structural Benefit Based on a Phase 3 Randomized, Placebo- and Active-Controlled Clinical Trial," was presented by C. Kent Kwoh, MD, MACR, Professor Emeritus of Medicine at The University of Arizona College of Medicine Tucson. Key Findings The poster presented an exploratory analysis evaluating whether TLC599, in addition to relieving pain, may also slow the structural progression of knee osteoarthritis. Joint space width — a standard X-ray measure of joint health — was assessed at baseline, Week 24, and Week 52 in patients receiving TLC599 12 mg (two injections) versus placebo. Results showed that TLC599-treated patients experienced approximately half the degree of joint space narrowing compared to those receiving placebo over one year. The consistency and direction of the findings represent a meaningful signal that warrants further investigation. These data complement TLC599's previously reported primary endpoint results, in which TLC599 12 mg demonstrated statistically significant superiority over placebo in reducing knee pain over 52 weeks, with a favorable safety profile. The full poster is available on the company website at www.tlcbio.com, under Research. Path Toward Disease-Modifying Status Current regulatory guidance from major agencies stipulates that a drug must demonstrate both symptomatic and structural benefit to qualify as a Disease-Modifying Osteoarthritis Drug (DMOAD) — a designation that no therapy has yet achieved for osteoarthritis. The data presented at OARSI 2026, taken together with TLC599's established pain relief profile, establish a scientific rationale for future studies to more definitively evaluate its potential structural effects 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. OARSI Poster

The release as fetched from its publisher. tlcbio.com ↗