SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Nov. 20, 2023 (GLOBE NEWSWIRE) -- 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 EXCELLENCE 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.
Efficacy and safety results:
- At Week 12, TLC599 was statistically superior to placebo in WOMAC Pain (p<0.05, the primary endpoint), as well as in WOMAC Function and Average Daily Pain (ADP). At this timepoint, TLC599 was also statistically superior to DSP as measured by ADP.
- TLC599 was numerically superior to placebo at all timepoints through Week 24 in WOMAC pain, and statistically superior to placebo as measured by ADP.
- A significantly higher proportion of patients in the TLC599 group had a 50% improvement in WOMAC Pain at Week 12 compared to placebo (48% vs. 36%, p <0.05).
- For Injection Period 2 (n=386), TLC599 ADP scores were statistically superior to placebo through Week 34 (p<0.05) and numerically superior through Week 52.
- TLC599 was well tolerated with a similar adverse event profile as placebo and DSP groups.
“TLC599 may provide prolonged benefits and be an alternative treatment to corticosteroids for the management of pain for people who have osteoarthritis of the knee,” Prof. Hunter concluded. These positive Phase 3 results suggest TLC599 could become an important new therapeutic option for patients with osteoarthritis of the knee.
About TLC BioSciences
TLC is a clinical-stage specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platforms (LipAD®). TLC’s expertise in liposome science allows for a combination of rapid onset and extended benefit duration, enhancing active drug concentrations while minimizing systemic exposures. TLC’s BioSeizer® technology enables local sustained release of therapeutic agents at the site of disease or injury, while its NanoX® active drug loading technology has been proven in two approved drugs, altering systemic exposure and potentially reducing dosing frequency. Versatile in active pharmaceutical ingredients and scalable in manufacturing, these technologies address unmet medical needs in orthopedics and pain management.
