TLC Announces First Patient Enrollment in EXCELLENCE Trial Evaluating Single and Repeat Administrations of TLC599Download
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, announced today that the first patient has been enrolled in EXCELLENCE, the Phase III pivotal clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain. TLC599 is a non-opioid, proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months.
The initiation of EXCELLENCE was supported by findings from a Phase II, randomized, double-blinded, placebo-controlled clinical trial in patients with OA of the knee, in which TLC599 12mg demonstrated statistically significant and clinically meaningful improvement in pain relief in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) scores compared to placebo from Day 3 all the way through the end of the study at 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 entire 24 weeks.
EXCELLENCE, the Phase III, multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal study, will evaluate the efficacy and safety of a single as well as a repeat dose of TLC599 12mg in approximately 500 patients with moderate to severe symptomatic knee OA with radiographic severity of Kellgren-Lawrence (KL) Grade 2 to 3. The trial will take place across 40-50 sites in the US and Australia. On Day 1, patients are randomized in a 2:1:1 ratio to receive an intraarticular injection of TLC599, DSP (a glucocorticoid widely used in the treatment of joint pain) or placebo (normal saline). At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Patient enrollment is expected take about one year; all patients will be followed for a total of 52 weeks.
The primary efficacy endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Key secondary endpoints include the magnitude of pain relief by WOMAC Pain or Function scores versus placebo or DSP at Weeks 16, 20, 24 and through 52 weeks as well as patient global impression of change (PGIC).
“We are optimistic about the results of EXCELLENCE,” remarked George Yeh, President of TLC. “If results are positive, the data would support a New Drug Application (NDA) for TLC599 with the US Food and Drug Administration (FDA). And if approved for repeat administration by the FDA, two simple injections of TLC599 would potentially alleviate the pain associated with OA for a full year, deterring the use of addictive opioids and avoiding the need for knee replacement surgery.”
More information on EXCELLENCE can be found on ClinicalTrials.gov.