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TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis Pain

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2020-12-28

On-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses

TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that patient enrollment of EXCELLENCE, the Phase III pivotal clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain, has been completed. 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.

“We are thrilled about the on-time completion of patient enrollment despite the slight hindrance caused by COVID-19 earlier on in the year. In these unprecedented times, we are especially grateful for the dedication of our research site staff and trial participants, whose commitment to EXCELLENCE facilitated the advancement of our lead program,” said George Yeh, President of TLC. “We will continue to monitor each patient closely as they receive the second injection. We believe that TLC599 has significant potential to benefit patients suffering from the agony of chronic OA pain while diminishing the need for opioids and the chances of becoming addicted to these dangerous substances. We remain confident that results from this trial will be positive given the outstanding results observed in our Phase II clinical trial.”

In the Phase II, randomized, double-blinded, placebo-controlled clinical trial in patients with OA of the knee, TLC599 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. Magnetic resonance imaging (MRI) evaluation of knee cartilage using the MRI Osteoarthritis Knee Score (MOAKS) instrument indicated that, comparing index to non-index knees, patients treated with TLC599 displayed relatively less cartilage loss than patients treated with placebo, suggesting there may be protection from cartilage degeneration by TLC599. The pattern of efficacy seen in the overall population was remarkably consistent between the various subgroups, which were categorized based on gender, age, Kellgren-Lawrence Grade, unilateral or bilateral pain, baseline VAS and WOMAC pain scores, and further confirm the potential therapeutic effects of TLC599.

EXCELLENCE, the Phase III, multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal study, is evaluating the efficacy and safety of a single as well as a repeat dose of TLC599 12mg in approximately 500 patients with knee OA across 46 sites in the US and Australia.

According to the US Department of Health and Human Services, 10.3 million people misused prescription opioids in 2018, and many die every day from opioid-related drug overdoses. The US Department of Justice announced in October that opioid maker Purdue Pharma would plead guilty to fueling the nation’s opioid crisis in a $8 billion settlement, and sued Walmart recently for unlawfully dispensing controlled substances through its pharmacies, certifying the gravity of the opioid crisis.

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