TLC Highlights Findings in Abstract Accepted at Osteoarthritis Research Society International (OARSI) 2020 and Published in Osteoarthritis and Cartilage
SOUTH SAN FRANCISCO, Calif.
“We are happy to see that results of the subgroup analyses are consistent with our primary efficacy data,” said
TLC599 is a BioSeizer® sustained release formulation of dexamethasone sodium phosphate. In a primary intent-to-treat analysis of a Phase II multi-center, randomized, double-blind, placebo-controlled clinical trial, a single intraarticular dose of TLC599 12mg demonstrated significant and durable pain relief and improved function compared to placebo over 24 weeks in patients with knee OA pain. To examine the robustness of this efficacy response, the changes in pain from baseline in subgroups of the intent-to-treat population were analyzed. Subgroups were categorized based on gender (male or female), age (50-65 years or 65+ years), Kellgren-Lawrence (K-L Grade 2 or Grade 3), pain in one or both knees (unilateral or bilateral), baseline Visual Analog Scale (VAS) pain scores (<7 or ≥7), and baseline
Current intraarticular anti-inflammatory treatments for OA have potentially toxic side effects and may lead to the destruction of cartilage filler proteins. An in vivo toxicity study by staining of the cartilage showed TLC599 to be cartilage sparing compared to current treatments. In a Phase II clinical trial, a single injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief in both WOMAC and VAS scores over placebo for 24 weeks. Over half of the patients in the TLC599 group had a durable response, maintaining at least 30% pain reduction in both WOMAC and VAS pain scores at all visits through the 24 weeks. EXCELLENCE, a multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal Phase III clinical trial to evaluate the efficacy and safety of both single and repeated doses of TLC599, is ongoing.
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