SOUTH SAN FRANCISCO, CA and TAIPEI, Taiwan
Professor David Hunter, Florance and Cope Chair of Rheumatology at the University of Sydney, presented detailed findings from the Phase 3 clinical trial of TLC599 at the American College of Rheumatology (ACR) Annual Meeting last week. TLC599 is an investigational therapy developed by TLC BioSciences for osteoarthritis knee pain. In his late-breaking oral presentation, Prof. Hunter provided background on osteoarthritis, introduced TLC599, and presented data showing TLC599’s potential to be a better treatment for managing osteoarthritis knee pain than currently available treatments.
Osteoarthritis is the most common joint disorder in the United States. Non-surgical treatments are limited, but include physical therapy, oral analgesics, NSAIDSs, and intraarticular injections. While steroid injections can provide pain relief and improve mobility, the duration of effect can be short and unpredictable. The EXCELLECE Phase 3 study of TLC599 was undertaken to confirm its benefit in knee osteoarthritis over 6 months and evaluate the additional improvement from a repeat injection.
TLC599 utilizes a multi-lamellar liposomal formulation to encapsulate dexamethasone sodium phosphate (DSP) and enable sustained release inside the joint, while also containing free DSP for rapid onset. In a Phase 2 study, TLC599 showed statistically significant improvements in WOMAC and VAS Pain scores versus placebo through Week 24, with similar trends in WOMAC Function and Stiffness, demonstrating durable pain reduction. The primary objective of the Phase 3 study was to confirm these Phase 2 results. Secondary objectives included assessing repeat dose efficacy and safety.
In this randomized, double-blind, controlled study, 504 patients with KL Grade 2-3 knee osteoarthritis were randomized to receive TLC599, DSP, or saline placebo. At Week 24, the TLC599 arm received TLC599 again, DSP arm switched to TLC599, and placebo arm received more placebo. The primary endpoint was change from baseline in WOMAC pain at Week 12 for TLC599 versus placebo.