TLC BioSciences Announces Phase II Publication of TLC599
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, March 07, 2022 (GLOBE NEWSWIRE) — TLC BioSciences, a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today today that detailed results from its TLC599 Phase 2 clinical trial in patients with knee osteoarthritis have been published in the peer-reviewed journal Arthritis research and therapy. TLC599 is a proprietary BioSeizer® sustained-release formulation of dexamethasone sodium phosphate (DSP) for the treatment of osteoarthritis pain. Results demonstrated a statistically significant reduction in pain scores and oral analgesic use for up to 6 months with TLC599.
The Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in 75 patients with knee osteoarthritis. Patients were randomized to receive a single intra-articular injection of TLC599 or placebo and evaluated for efficacy and safety for 24 weeks. Patient-reported outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC) for pain and function and the visual analog scale (VAS) for pain. Acetaminophen was allowed as the only analgesic; other painkillers, including NSAIDs and opioids, were not allowed.
The results showed that TLC599 demonstrated a statistically significantly greater reduction in pain and WOMAC function as well as VAS scores compared to placebo for 24 weeks. Acetaminophen use in the TLC599 group was statistically significantly lower than in the placebo group at most time points.
“Acetaminophen is a mild pain reliever with little significant clinical benefit and real risk of harm, and the American Academy of Orthopedic Surgeons suggests no more than 3000 mg per day to minimize its risk of liver damage,” said Dr. David Hunter, lead author of the study. manuscript and Professor of Medicine at the University of Sydney. “As patients in the TLC599 group were observed to consume significantly less acetaminophen than the placebo group, TLC599 has the potential to reduce the need for oral medication use in a setting where opioids are frequently used to control pain.”
The research article, titled “TLC599 in Patients with Knee Osteoarthritis: A Phase IIa, Randomized, Placebo-Controlled, Dose-Finding Study,” is available at Arthritis research and therapy. The publication is an international peer-reviewed journal publishing original articles in musculoskeletal research and therapy.
“The U.S. Centers for Disease Control and Prevention is offering new guidelines for the treatment of acute and chronic pain, recommending physicians turn to non-opioid therapies first whenever possible,” George said. Yeh, president of TLC BioSciences. “We believe that our Phase 2 results as well as the impending Phase 3 results will show that TLC599 is a timely non-opioid therapy for the treatment of chronic osteoarthritis pain.”
EXCELLENCE, a pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, active-comparator study evaluating the efficacy and safety of single and repeat dose TLC599 in approximately 500 patients with osteoarthritis of the knee, completed the study last visit the last patient. EXCELLENCE results are expected this year.
About TLC BioSciences
TLC BioSciences 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 platform (LipAD®). TLC’s extensive experience with liposome science enables a combination of speed of onset and duration of benefits, improving active drug concentrations while decreasing unwanted systemic exposures. TLC BioSeizer® the technology is designed to provide sustained local delivery of therapeutic agents to the site of disease or injury; its NanoX® Active drug loading technology has been proven in two approved drugs and is designed to alter the systemic exposure of a drug, potentially reducing dosing frequency and improving the delivery of active agents encapsulated in liposomes to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse portfolio of proprietary therapeutic products that target areas of unmet medical need in pain management, infectious disease, ophthalmology and oncology.