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 for doctors and patients seeking post-operative pain management – including opioid reduction or elimination - as quickly as possible." He added "We have also had successful recent interactions with the FDA regarding two of our pre-clinical pipeline products, with clear and thoughtful guidelines provided for development of a suite of products that could help serve doctors and patients around the world."
CPL-01 is an extended-release injectable formulation of Naropin® (ropivacaine hydrochloride), which is a member of the amino amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Naropin® (ropivacaine hydrochloride) Injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect, frequent injections or infusion by catheter are required if protracted local analgesia is required for postoperative pain management. As a result, Cali Biosciences has developed CPL-01 based on Naropin® Injection and PG-Depot technology platform in order to prolong its duration at the local site, leading to an extended local analgesic effect.