TLC to Present Phase 3 Data of TLC599 in Late-Breaking Abstracts Session at ACR
Clinical benefits sustained to 24 weeks; second injection furthered benefits to 52 weeks
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Nov. 08, 2023 (GLOBE NEWSWIRE) -- (TLC), a late clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical needs in orthopedic disorders, today announced that the Abstract Selection Committee of the American College of Rheumatology (ACR) has accepted TLC's late-breaking abstract on TLC599 for oral presentation at ACR Convergence 2023. This will take place November 10–15 at the San Diego Convention Center in San Diego, California. TLC599 is a proprietary BioSeizer® sustained release injectable in development for the treatment of osteoarthritis pain.
| Details of the event and presentation are as follows: | |
| Session: | Late-Breaking Abstracts |
| Time / Date: | 8:30am - 8:45am, Wednesday, November 15, 2023 |
| Abstract ID: | 1651410 |
| Final Number: | L19 |
| Abstract Title: | A Phase 3 Study of Repeat Injection of TLC599 in Osteoarthritis of the Knee: Benefits to 52 Weeks |
“We are pleased that the ACR has recognized the importance of this Phase 3 data by selecting it for presentation,” said Dr. David Hunter, Florance and Cope Chair of Rheumatology at University of Sydney and principal investigator on the Phase 2 and Phase 3 clinical trials for TLC599. “The data from this pivotal Phase 3 trial demonstrates the sustained efficacy and safety of TLC599 out to 52 weeks. We look forward to sharing these important findings with the rheumatology community.”
The Phase 3 study, named EXCELLENCE, was a randomized, double-blinded, placebo- and active-controlled study to evaluate the efficacy and safety of TLC599 in single or repeat doses, in patients with osteoarthritis of the knee. On the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale, TLC599 was statistically superior at Week 12, the primary endpoint, and numerically superior to placebo at all time points through the first injection period. On the average daily pain (ADP) scale, TLC599 was numerically and statistically superior to placebo at all time points during the first injection period. Additionally, the reduction in ADP for TLC599 was statistically superior to the active comparator at Week 12. In the second injection period, the mean reduction in ADP from the first injection baseline for TLC599 was numerically superior to placebo at all time points through Week 52 and statistically superior through Week 34. TLC599 was generally well tolerated, with the number and type of adverse events similar among all three treatment groups.
“The 52-week results demonstrate that TLC599 can deliver durable pain relief and functional improvement, offering an important new treatment option in the management of osteoarthritis knee pain,” said Dr. George Spencer-Green, Chief Medical Officer at TLC BioSciences. “These important data underscore our commitment to developing therapies that provide sustained benefits and meet the needs of patients living with chronic pain conditions.”
About TLC599
TLC599 is an extended and controlled release liposomal corticosteroid injectable in development for the treatment of osteoarthritis pain. Single and repeated doses of current intraarticular anti-inflammatory treatments for osteoarthritis have potentially toxic side effects and may lead to the destruction of cartilage filler proteins. Preclinical toxicity studies showed no marked cartilage damage after single and multiple doses of TLC599 when compared to current treatments. In a Phase II clinical trial, a single injection of TLC599 resulted in statistically significant and clinically meaningful improvement in WOMAC Pain and Function subscales, and VAS Pain scores over placebo at 12, 16 and 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. No serious or unexpected treatment related adverse events were reported, and most of the treatment related adverse events were mild to moderate in severity.
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.
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