TLC Highlights Findings in Abstract Accepted at Osteoarthritis Research Society International (OARSI) 2020 and Published in Osteoarthritis and Cartilage

Rhea-AI Summary

TLC (Nasdaq: TLC, TWO: 4152) announced positive subgroup analysis results from a Phase II clinical trial for TLC599, demonstrating sustained pain relief in osteoarthritis patients. Efficacy was consistent across various demographics, with significant reductions in pain sustained from Week 1 to Week 24. TLC599, a BioSeizer® formulation of dexamethasone sodium phosphate, showed promising results, making it a potential effective treatment for over 300 million adults affected by osteoarthritis. Ongoing Phase III trials will further evaluate its efficacy and safety.

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Positive

• Subgroup analyses from the Phase II trial showed consistent pain reduction across different demographics.
• TLC599 demonstrated significant and durable pain relief over 24 weeks compared to placebo.
• The product is designed to be cartilage-sparing, addressing a major concern with current treatments.

Negative

• None.

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SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, May 18, 2020 (GLOBE NEWSWIRE) -- TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, today announced the publication of data from subgroup analyses from the Phase II clinical trial of TLC599 in patients with osteoarthritis (OA) knee pain, which showed that the pattern of efficacy seen in the overall population, with greater reductions in pain with TLC599 than with placebo that sustained from Week 1 through Week 24, was remarkably consistent between the various subgroups. These findings were accepted as an abstract at Osteoarthritis Research Society International (OARSI) 2020 and published in the Osteoarthritis and Cartilage journal (#722).

“We are happy to see that results of the subgroup analyses are consistent with our primary efficacy data,” said George Yeh, President of TLC. “These findings further substantiate the robustness of the potential therapeutic effects that TLC599 has in extensively alleviating pain and discomfort across different segments of the population with osteoarthritis, a disease that affects over 300 million adults worldwide.”

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 Western Ontario and McMaster Universities Index (WOMAC) pain scores (<1.2 or ≥1.2). The pattern of durable pain reduction with TLC599 was generally consistent across all subgroups, with drastic reductions in pain by the first visit (Week 1) which maintained through the 24-week duration of the trial.

About TLC599

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.

About TLC

TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of a diverse, wholly owned portfolio of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™), including BioSeizer^® sustained release technology and NanoX™ active drug loading technology, which are versatile in the choice of active pharmaceutical ingredients and scalable in manufacturing.

TLC Contact:
Dawn Chi
Corporate Communications

FAQ

What were the results of the Phase II trial for TLC599?

The Phase II trial of TLC599 showed consistent pain relief in osteoarthritis patients, with significant reductions sustained from Week 1 through Week 24.

How does TLC599 work as a treatment?

TLC599 is a BioSeizer® sustained release formulation of dexamethasone sodium phosphate, designed to provide long-lasting pain relief.

What is the ongoing trial for TLC599?

The EXCELLENCE trial is a Phase III study evaluating the efficacy and safety of single and repeated doses of TLC599.

How many people are affected by osteoarthritis worldwide?

Osteoarthritis affects over 300 million adults globally.

What makes TLC599 different from current treatments?

TLC599 is designed to be cartilage-sparing, potentially avoiding the toxic side effects associated with other intraarticular anti-inflammatory treatments.