TLC BioSciences announced that detailed results of its TLC599 Phase 2 clinical trial in patients with osteoarthritis of the knee have been published in the peer-reviewed journal Arthritis Research & Therapy. TLC599 is a proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate (DSP) intended for the treatment of osteoarthritis pain. The results demonstrated statistically significantly reduced pain scores and oral pain medication 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 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 Western Ontario and McMaster Universities Arthritis (WOMAC) Index for pain and function and visual analog scale (VAS) for pain.

Acetaminophen was permitted as the only pain rescue medication; other pain medications including NSAIDs and opioids were not permitted. 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.