TLC BioSciences Announces Publication of TLC599 Phase II Results in Arthritis Research & Therapy
The Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in 75 patients with osteoarthritis of the knee. Patients were randomized and administered a single intraarticular injection of TLC599 or placebo and assessed for efficacy and safety for 24 weeks. Patient-reported outcomes included the
Results showed that TLC599 demonstrated statistically significantly greater reduction in WOMAC pain and function as well as VAS scores compared to placebo through 24 weeks. Acetaminophen use in the TLC599 group was statistically significantly lower than that of the placebo group at most time points.
“Acetaminophen is a mild analgesic with little meaningful clinical benefit and real risks of harm, and the
The research article, titled “TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study”, is available on
EXCELLENCE, a Phase 3, multicenter, randomized, double-blind, placebo- and active comparator-controlled pivotal study evaluating the efficacy and safety of a single as well as a repeat dose of TLC599 in approximately 500 patients with knee osteoarthritis, has completed the last patient’s last visit. Results from EXCELLENCE 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 deep experience with liposome science allows a combination of onset speed and benefit duration, improving active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer® technology is designed to enable local sustained release of therapeutic agents at 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 enhancing distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients, and scalable with respect to manufacturing.
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