Cali Biosciences Initiates Phase 2b Study of Long-Acting Ropivacaine for Non-Opioid Treatment of Post-Operative Pain

Cali Biosciences Co., Ltd., a global biopharmaceutical company focused on the research and development of innovative drugs, announced it has initiated a Phase 2b study of its perioperative long-acting analgesic product CPL- 01.

CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by CaliBio to treat post-operative surgical pain and reduce the need for opioids. This Phase 2b 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 anesthesiologist who has participated in clinical trials of prior long-acting local anesthetics 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. Erol Onel, Chief Medical Officer at CaliBio who has developed several other long-acting local anesthetics, agreed, "We need to do all that we can to help patients control or eliminate their post-operative pain, while continuing to chip away at the opioid crisis."

Dr. PJ Chen, Chief Executive Officer of CaliBio, commented, "CPL-01 is the core product of CaliBio's product pipeline in perioperative analgesia, anesthesia, and anti-inflammation drug solutions.  The successful enrollment of the first subject in the phase 2b clinical trial is yet another important milestone in CPL-01's R&D progress. Last year, we completed the Phase 2a 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. We look forward to serving more doctors and patients worldwide."

About CPL-01

CPL-01 is an extended-release injectable gel 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, the CaliBio develops 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.

About Cali Biosciences

Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021 as the parent company of Cali Pharmaceuticals, LLC, a principal subsidiary of the Cali Group which was established in San Diego, USA, in 2016, and later built its global headquarter in Shenzhen and a Clinical Development Center in Shanghai, China. CaliBio is an innovative international biopharmaceutical company with a number of licensed independent research and development technology platforms, as well as an international scientific research and management team. It has been committed to R&D, production and sales for clinical and Innovative drugs in the surgical perioperative field to fully respond to unmet clinical and market needs. CaliBio's product pipeline includes modified formulations and new drugs in the fields of anesthesia, analgesia, anti-inflammatory and anti-infection. The company is committed to serving patients and medical staff around the world.