• Primary endpoint and key secondary endpoints met
  • TLC599 demonstrated statistically significant improvement over placebo through  Weeks 12, 16, 20, and 24
  • TLC599 was well-tolerated with no treatment-related serious adverse events

TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Aug. 20, 2018 (GLOBE NEWSWIRE) -- Taiwan Liposome Company, Ltd. (4152.TWO; “TLC”), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in pain management, ophthalmology, and oncology, today reported positive top-line results from the Phase II clinical trial of its lead product candidate, TLC599, a proprietary BioSeizer™ formulation of dexamethasone sodium phosphate (DSP) intended for the treatment of osteoarthritis (OA) pain.

“Patients with osteoarthritis want a therapy that can provide fast onset and long duration pain relief so they can have a better quality of life. I am impressed with TLC599’s ability to consistently provide fast and durable pain relief in the majority of patients for the entire follow-up period of six months,” commented Dr. David Hunter, Florance and Cope Chair of Rheumatology and Professor of Medicine at University of Sydney and the Royal North Shore Hospital, and lead investigator of the study. “The durability of TLC599 is the longest that I have ever seen amongst all extended release intra-articular steroid injections.”

The multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial evaluated the safety and efficacy of  intra-articular injections of 12mg of TLC599 and 18mg of TLC599 compared to placebo (saline) in 75 patients with knee OA pain. Patients were followed up for efficacy and safety through Week 24. The primary endpoint is the change from baseline in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale through Week 12.

Results from the top-line data showed:

  • 12mg of TLC599 demonstrated a statistically significant improvement in pain relief compared to placebo from Day 3 through Week 12 (p = 0.0027), meeting the primary endpoint.
  • Furthermore, 12mg of TLC599 demonstrated statistically significant improvement in pain relief compared to placebo from Day 3 through Week 16 (p = 0.0024), Week 20 (p = 0.0033), and Week 24 (p = 0.0038).  
  • A majority of patients in the 12mg group of TLC599 group were durable responders, with a persistent response of >30% pain relief at all visits through Week 24. 
  • TLC599 showed rapid onset of pain relief, with a robust magnitude of effect observed as early as the first post-administration assessment at Day 3.
  • TLC599 was well tolerated, with comparable frequency of treatment-related adverse events for both doses of TLC599 and placebo. Most adverse events were mild. There were no treatment-related serious adverse events.

“We are very pleased with the data from the Phase II trial. These top-line results are consistent with our prior Phase I/II data and also demonstrate sustained efficacy of up to six months for TLC599,” commented TLC President George Yeh. “There is an outstanding unmet need for extended duration pain relief in the management of osteoarthritis. Based on the results, we believe that TLC599’s profile will transform the landscape of therapeutic options that are currently available to patients suffering from osteoarthritis. We look forward to presenting the full data set at future scientific congresses and meeting with regulatory authorities to discuss next steps.”

About TLC599
TLC599 is a BioSeizer sustained release formulation of dexamethasone sodium phosphate (DSP) intended for the treatment of osteoarthritis (OA) pain. OA is a joint disorder involving the degeneration of the articular cartilage that leads to inflammation of the soft tissue and bony structures of the joint. Current intraarticular sustained release anti-inflammatory treatments for OA have potentially toxic side effects and may lead to the destruction of cartilage filler proteins called proteoglycans, resulting in chondrotoxicity. An in vivo toxicity study by proteoglycan staining of the cartilage showed TLC599 to be cartilage sparing compared to the current treatment. Data from its Phase I/II clinical trial demonstrated that a single dose of TLC599 at 6mg or 12 mg DSP led to rapid improvements in visual analog scale (VAS) pain scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Decreases in VAS and WOMAC were observed at one week post-injection and persisted without notable loss of effect through the end of the trial at 12 weeks; the extent of decrease in WOMAC score exceeded the minimally clinically important different cutoff according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International, indicating the improvement in symptoms was clinically meaningful. Phase II clinical trial extended the evaluation period to 24-weeks to better establish duration of efficacy.

About TLC
TLC (4152.TWO) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of best-in-class novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™). TLC believes that its deep experience with liposome science allows TLC to combine onset speed and benefit duration, while establishing drug levels at target tissues without incurring large systemic exposures. TLC’s BioSeizer technology enables local sustained release of therapeutic agents at the site of disease or injury; its NanoX targeted delivery technology enables prolonged pharmacokinetic profiles and enhanced distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. 

Forward-looking Statements
This press release contains forward-looking statements. Words such as “may,” “believe,” “will,” “expect,” “potential,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of unknown risks, assumptions, uncertainties and factors that are beyond TLC’s control. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC599 for the treatment of knee OA pain, the clinical benefits of TLC599 for people with knee OA pain, the timing, scope and results of clinical trials, the timing and reporting of clinical data for TLC’s product candidates and the association of data with treatment outcomes. All forward-looking statements are based on TLC’s expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

Contacts: Taiwan Liposome Company (TLC) Dawn Chi Corporate Communications +886 2 2655 7377 ext. 136 Solebury Trout Julia Balanova Vice President +1 646 378 2936