TLC Announces Positive End-of-Phase II Meeting with FDA for TLC599 in Knee Osteoarthritis
“We are pleased with the positive outcome from this meeting, where we and the
The Phase III clinical trial will be a global, randomized, double-blind, placebo- and active-controlled study to evaluate the safety and efficacy of a single dose – as well as repeated doses – of TLC599 in patients with knee osteoarthritis. Approximately 500 patients will be randomized into three groups at a 2:1:1 ratio, with each group receiving TLC599 12mg, DSP 4mg (active control), or saline (placebo), respectively. Key endpoints will include change from baseline in the
“We had a productive and collaborative meeting with the
This End-of-Phase II meeting took place following positive results from a successfully completed Phase II clinical trial, which evaluated the safety and efficacy of a single intra-articular injection of TLC599 against placebo in patients with knee osteoarthritis through 24 weeks. Results from this trial showed statistically significant improvement in pain relief compared to placebo from Day 3 through Weeks 12, 16, 20, and 24 as well as at every scheduled visit. A majority of patients in the TLC599 group were clinically durable responders, maintaining at least 30% reduction in pain from baseline at all visits through Week 24.
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. An in vivo toxicity study by staining of the cartilage showed TLC599 to be cartilage sparing compared to current treatments. In its Phase II clinical trial, TLC599 was well-tolerated, fast-acting, and demonstrated statistically significant and clinically meaningful improvement in pain relief compared to placebo from Day 3 through Weeks 12, 16, 20 and 24.
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 prospectus dated
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