Cali Biosciences (CaliBio) has initiated a Phase IIb study of its perioperative long-acting analgesic product CPL- 01, an extended-release injectable version of Naropin (ropivacaine hydrochloride), developed to treat post-operative surgical pain and reduce the need for opioids.
This Phase IIb clinical trial is the first in a series of MERIT studies (Management of post-op pain and Evaluation of Reduction in Therapeutic opioids), designed to further investigate the clinical advantages of CPL-01 and to compare with those of existing pain management drugs on the market. The MERIT-1 study, focused on inguinal hernia repair, is currently being conducted entirely in the United States.
Dr Todd Bertoch, an anaesthesiologist who has participated in clinical trials of prior long-acting local anaesthetics and a principal investigator in this study, said: “This is an important step; ropivacaine is generally considered safer than bupivacaine, and there are no long-acting ropivacaine options currently available to help our patients with their post-operative pain.”
Dr PJ Chen, Chief Executive Officer of CaliBio, said: “CPL-01 is the core product of CaliBio’s product pipeline in perioperative analgesia, anaesthesia and anti-inflammation drug solutions. The successful enrolment of the first subject in the Phase IIb clinical trial is yet another important milestone in CPL-01’s R&D progress.
“Last year, we completed the Phase IIa clinical trial of CPL-01 in the United States. In the study, there were no safety or tolerability issues with CPL-01 based on the PK and safety results. We are confident that CPL-01 will meet the clinical unmet needs and provide a new and better option for doctors and patients post-operative pain management.”