South San Francisco, CA and Taipei, Taiwan (GLOBE NEWSWIRE) - TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, announced today that the first patient has been enrolled in EXCELLENCE, the Phase III pivotal clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain. 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.
The initiation of EXCELLENCE was supported by findings from a Phase II, randomized, double-blinded, placebo-controlled clinical trial in patients with OA of the knee, in which TLC599 12mg 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. Over half of the patients in the TLC599 group had a durable response, maintaining at least 30% pain reduction in both WOMAC and VAS pain scores at all visits through the entire 24 weeks.
EXCELLENCE, the Phase III, multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal study, will evaluate the efficacy and safety of a single as well as a repeat dose of TLC599 12mg in approximately 500 patients with moderate to severe symptomatic knee OA with radiographic severity of Kellgren-Lawrence (KL) Grade 2 to 3. The trial will take place across 40-50 sites in the US and Australia. On Day 1, patients are randomized in a 2:1:1 ratio to receive an intraarticular injection of TLC599, DSP (a glucocorticoid widely used in the treatment of joint pain) or placebo (normal saline). At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Patient enrollment is expected take about one year; all patients will be followed for a total of 52 weeks.
The primary efficacy endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Key secondary endpoints include the magnitude of pain relief by WOMAC Pain or Function scores versus placebo or DSP at Weeks 16, 20, 24 and through 52 weeks as well as patient global impression of change (PGIC).
“We are optimistic about the results of EXCELLENCE,” remarked George Yeh, President of TLC. “If results are positive, the data would support a New Drug Application (NDA) for TLC599 with the US Food and Drug Administration (FDA). And if approved for repeat administration by the FDA, two simple injections of TLC599 would potentially alleviate the pain associated with OA for a full year, deterring the use of addictive opioids and avoiding the need for knee replacement surgery.”
More information on EXCELLENCE can be found on ClinicalTrials.gov.
TLC599 is a BioSeizer® sustained release formulation of DSP intended for the treatment of OA pain. Current intraarticular anti-inflammatory treatments for OA have potentially toxic side effects and may lead to the destruction of cartilage filler proteins. An in vivo toxicity study by staining of the cartilage showed TLC599 to be cartilage sparing compared to current treatments. In a Phase II clinical trial, a single injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief in both WOMAC and VAS scores compared to placebo through 24 weeks. EXCELLENCE, a multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal Phase III clinical trial to evaluate the efficacy and safety of both single and repeated doses of TLC599, is currently underway.
TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of 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 a combination of onset speed and benefit duration, improving active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer® technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX™ active drug loading technology has been proven in two approved drugs and is designed to alter the systemic exposure of a drug, potentially reducing dosing frequency and enhancing 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC599, the clinical benefits of TLC599 for knee osteoarthritis, the timing, scope, progress and outcome of the clinical trials, and the anticipated timelines for the release of clinical data. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “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 risks, assumptions, uncertainties and factors, including risks that the outcome of any clinical trial is inherently uncertain and TLC599 or any of our other product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval. Other risks are described in the Risk Factors section of TLC’s annual report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission. 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.
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