Taiwan Liposome Company (Nasdaq: TLC) has declared that patient enrolment in EXCELLENCE, the pivotal Phase III clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain, is complete. Efficacious treatment for OA pain for up to six months, TLC599 is a non-opioid, proprietary Bio Seizer formulation containing dexamethasone sodium phosphate (DSP).
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“Despite the slight hindrance caused by COVID-19 earlier in the year, we are thrilled about the on-time completion of patient enrolment. The dedication of our research staff and trial participants in these unprecedented times, whose commitment to EXCELLENCE facilitated the advancement of our lead program, said George Yeh, President of Taiwan Liposome Company.”
“He continued. Each patient will be closely monitored as they receive a second injection. TLC599 can significantly benefit patients suffering from chronic pain associated with OA while diminishing their dependence on opioids and chances of addiction to these addictive substances.Based on the outstanding results observed in our Phase II clinical trial, we remain confident that the results from this trial will be positive.”
Based on Phase II, a randomized, double-blinded, placebo-controlled clinical trial in people with knee osteoarthritis, TLC599 demonstrated statistically significant and clinically meaningful pain relief compared to placebo from Day 3 through the 24-week study.
Patients treated with TLC599 displayed relatively less cartilage loss than patients treated with a placebo in an MRI evaluation of knee cartilage using the MRI Osteoarthritis Knee Score (MOAKS) instrument, showing the drug might deliver protection from cartilage loss.
TLC599 exhibited a surprising efficacy pattern across multiple subgroups based on gender, age, Kellgren Lawrence Grade, unilateral or bilateral pain, and baseline VAS and WOMAC pain scores, confirming the therapeutic effect TLC599.
Individuals with knee osteoarthritis at approximately 500 sites across the US and Australia are included in EXCELLENCE, the novel Phase III, multicenter, randomized, double-blind, placebo- and active comparator-controlled pivotal study.
The US Department of Health and Human Services reports that 10.3 million people misused prescription opioids in 2018, and many died every day of opioid-related overdoses. Purdue Pharma pleaded guilty in October to fuel the nation’s opioid crisis in an $8 billion settlement. Walmart was sued recently for unlawfully dispensing controlled substances through its pharmacies, recognizing the gravity of the opioid crisis.