At Janney’s Osteoarthritis and Pain Therapeutic Forum, TLC (4152.TWO) showcased its solutions to pain management and demonstrated superiorities in its data against peers during the 30-minute presentation.
TLC President George Yeh was invited to attend the analyst-led forum at The Union League Club in New York, where he started by addressing the current challenges in intraarticular treatments for osteoarthritis (OA), including short drug retention and rapid clearance in the joint, importance of immediate onset, and cartilage cell death. Mr. Yeh then presented product candidate TLC599 as a solution to these issues. Once approved, TLC599 will be the world’s first multilamellar and multivesicular lipid formulation of dexamethasone sodium phosphate for OA. With a high potency active pharmaceutical ingredient (API), TLC599 has high drug loading, meaning smaller injection volumes that will not require synovial fluid aspiration prior to injection and will not cause distension pain. A three-month long animal study showed no cartilage damage or chondrotoxicity even with a repeated-dose, suggesting viability of multiple doses. TLC599 can be injected using a range of needle sizes from 21G to 30G, indicating flexibility in broader applications into smaller joints. The optimized particle size of TLC599 at around 0.4µm means that it is big enough not escape from the joint cavity yet small enough not to be phagocytosed; manufacturing requires only sterile filtration instead of an entirely aseptic process, reducing costs. A phase II study of TLC599 is currently underway.
Product candidate TLC590 is ropivacaine in multilamellar liposome for infiltration injection. Just one shot of TLC590 provides quick and effective post-surgical pain management for up to three days instead of mere hours as with existing drugs. Ropivacaine was selected as API due to its lower toxicity profile compared to bupivacaine. The manufacturing process of TLC590, as with TLC599, is scalable, reproducible, and bypasses aseptic processes, which means lower COGS. Both product candidates have strong intellectual property protection worldwide well into 2033 and invaluable manufacturing know-how.
Click here to view the presentation used at Janney’s Osteoarthritis and Pain Therapeutic Forum on the TLC website (www.tlcbio.com) under Investors / Events & Presentations.