TLC Announces Dosing of First Patients in Part 2 of TLC590 Phase II Trial for Postsurgical Pain following Bunionectomy
- Part 2 will dose ~150 patients with TLC590, bupivacaine, or placebo
- Primary endpoint: AUC0-72 on numerical pain rating scale
- Enrollment of all patients to take ~3 months
Part 1 of the two-part Phase II clinical trial, completed last year, was a blinded pharmacokinetics study of TLC590 and ropivacaine. In Part 1, TLC590 showed a clear linear pharmacokinetic profile. All three doses of TLC590 (152mg, 190mg, and 228mg) were well tolerated, with a safety profile comparable to ropivacaine. The highest dose, TLC590 228mg, was chosen for Part 2 based on the maximum feasible volume for bunionectomy.
Part 2 of the Phase II clinical trial is an efficacy and safety study of TLC590 versus bupivacaine and placebo. Approximately 150 patients will be randomized at the ratio of 1:1:1 to receive a single infiltrative local dose of TLC590 228mg, bupivacaine 50mg or normal saline placebo at the end of their bunionectomy surgery. The primary endpoint is area under the curve (AUC) from 0 to 72 hours on the numerical pain rating scale. Secondary endpoints include proportion of pain-free patients, proportion of opioid-free patients, and total post-operative opioid consumption at various time periods, plus time to the first post-operative use of opioids. Enrollment of all patients is expected to take approximately three months, and topline data is expected in mid-2020.
“We are happy to have kicked off Part 2 of this trial,” said
More information on the clinical trials of TLC590 can be found on ClinicalTrials.gov.
TLC590 is a non-opioid, BioSeizer® sustained release formulation of ropivacaine designed to prolong the retention time of ropivacaine around the injection site as a drug depot, simultaneously extending its therapeutic period and reducing unwanted systemic exposure. In a Phase I/II, randomized, double-blind, comparator-controlled dose escalation study following hernia repair surgery (a type of soft tissue surgical operation), TLC590 demonstrated statistically significant and clinically meaningful reductions in pain intensity with movement over ropivacaine as measured by AUC0-24h (p=0.0057), AUC0-48h (p=0.0131), AUC0-72h (p=0.0117) and AUC0-96h (p=0.0103). Time to first opioid use in the TLC590 group was four times that of the ropivacaine group. Mean total opioid consumption through 96 hours post-surgery in the TLC590 group was 54% less than the ropivacaine group.
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 TLC590, the clinical benefits of TLC590 for postsurgical pain management, 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 TLC590 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