TLC Announces Dosing of First Patients in Part 2 of TLC590 Phase II Trial for Postsurgical Pain following Bunionectomyダウンロード
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 batch of patients has been dosed in Part 2 of the Phase II clinical trial for TLC590 in patients following bunionectomy surgery. TLC590 is a non-opioid, proprietary BioSeizer® sustained release formulation of ropivacaine intended to manage postsurgical pain for three days or more with a single dose, potentially reducing the need for opioids following surgery.
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 George Yeh, President of TLC. “The use of bupivacaine as active comparator will allow a relevant, real-world demonstration of the potential advantages of TLC590 over the current standard of care. We very much look forward to observing a continued positive performance by TLC590, and to seeing further evidence of TLC590 as a viable alternative to addictive opioids.”
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.