Clinical benefits sustained to 24 weeks; second injection furthered benefits to 52 weeks
TLC BioSciences (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.”