Cali Biosciences Initiates Phase III Studies of CPL-01 (Long-Acting Ropivacaine)… – Press Release


Subjects in Herniorrhaphy Study Dosed
Successful FDA Interactions on Two Pre-clinical Pipeline Products Also Discussed

SAN DIEGO, April 18, 2023 /PRNewswire/ — Cali Biosciences Co., Ltd. (hereinafter referred to as “Cali” or “Cali Biosciences”), a biopharmaceutical company focused on the research and development of innovative drugs in the peri-operative space, announced it has initiated Phase III studies of its core product, CPL-01 (long-acting ropivacaine), with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month.

CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by Cali to treat post-operative surgical pain and reduce or eliminate the need for opioids.

Dr. Todd Bertoch, a principal investigator in this study, said, “Having been involved in some of Cali’s Phase II studies, I really look forward to CPL-01 showing its excellent results and safety profile in Phase III. I have helped to study other long-acting local anesthetics prior to their approval, and am especially excited for this as it is positioned to be the first long-acting ropivacaine to hit the market.”

Dr. Erol Onel, Chief Medical Officer at Cali Biosciences US, LLC who has developed several other long-acting local anesthetics, agreed and stated, “it is widely accepted that ropivacaine has a better safety profile than bupivacaine, so moving ahead with a long-acting ropivacaine just made sense – the next step in the evolution of non-opioid pain control.”

Mr. PJ Chen, Chief Executive Officer of Cali Biosciences, commented, “CPL-01 is the core product of Cali Biosciences’ product pipeline in the peri-operative space, and initiating enrollment in our phase III clinical trials is an important milestone in CPL-01’s R&D progress. We are confident that the phase III results will build on our successful Phase II results, and add to the encouraging data we’ve seen so far so we can provide a new and better option…