Taiwan Liposome Company (TLC) has dosed the first patients in a Phase I/II trial to investigate TLC590 in comparison with free, non-liposomal ropivacaine when given as a single infiltrative local administration for the treatment of adult patients following inguinal hernia repair surgery.
The randomised, double-blind, comparator-controlled, dose-escalation trial has so far included 12 patients, three of whom were dosed.
The trial aims to analyse the safety, tolerability, pharmacokinetics (PK), dose-exposure relationships, and analgesic efficacy of dose escalation of TLC590 compared to free, non-liposomal ropivacaine.
It is currently being carried out in the US with plans to enrol around 64 patients who will be followed up for 30 days after surgery and dosing.
Taiwan Liposome Company founder, chairman and CEO Dr Keelung Hong said: “TLC590 is formulated with our proprietary BioSeizer liposome technology, which has a dense multilamellar structure capable of providing high-concentration drug loading and continuous release of ropivacaine,.
“Our preclinical studies have shown TLC590 to display statistically significant analgesic efficacy compared to liposomal bupivacaine, and we are excited to have begun dosing patients in our first-in-human clinical trial to demonstrate TLC590 as a potentially best-in-class drug for postsurgical pain management that may serve as a safe, non-opioid solution to the opioid epidemic.”
Ropivacaine, a common local anesthetic drug in the amino amide group that was developed after bupivacaine, was previously demonstrated to have less cardiovascular and central nervous system toxicity than bupivacaine.
Bupivacaine is currently being used in the US and has demonstrated significant efficacy up to 24 hours post-surgery, but showed minimal to no efficacy between 24 and 72 hours after administration.