Cali Biosciences Begins and Immediately Fulfills Initial Enrollment for Long-Acting Ropivacaine (CPL-01) Phase II Trial in Bunionectomy
Cali Biosciences Co., Ltd. (hereinafter referred to as "CaliBio"), a global biopharmaceutical company focused on the research and development of innovative drugs, announced it has initiated a Phase II bunionectomy study of its peri-operative long-acting ropivacaine product (CPL- 01) for post-operative pain control and opioid reduction through 72 hours after bunionectomy. In a surprise, all slots in the initial cohort of the trial immediately filled.
Dr. Todd Bertoch, an anesthesiologist who has participated in clinical trials of other prior long-acting local anesthetics and a principal investigator in this study, said, "The fact that all available slots filled in just a few weeks is a tribute to the organization and care that CaliBio brings to organizing and executing on these studies, while also speaking to the unmet need of having a safe and effective long-acting ropivacaine with a broad approval.” Dr. Erol Onel, Chief Medical Officer of CaliBio US who has developed several other long-acting local anesthetics, agreed, "A successful trial in a bony surgery, like bunionectomy, will build on our already demonstrated success from our prior hernia and abdominoplasty trials. This should continue to help patients control or eliminate their post-operative pain, while decreasing any need for opioids."
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 II hallux valgus and bunion clinical trial is the second study 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 in hallux valgus and bunion. The MERIT-2 study, focused on hallux valgus and bunion, is currently being conducted in 4 clinical trial sites of United States. At present, all the sites have been fully activated, with completed patients' screening and recruitment.
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. I am pleased with the recent progress in accelerating our CPL-01 Phase II clinical trial related activities. We completed the Phase II inguinal herniorrhaphy clinical trial of CPL-01 in the United States and the results show that CPL-01 can relieve post-operative pain effectively and dramatically reduce opioid use. We are confident that CPL-01 will meet the clinical unmet needs and provide a new and better option for doctors and patients seeking post-operative pain management – including opioid reduction. We look forward to serving more doctors and patients worldwide."
CPL-01 is an extended-release injectable formulation of Naropin® (ropivacaine hydrochloride), which is a member of the 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 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.
About Cali Biosciences
Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021 as the parent company of Cali Biosciences LLC, US, 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 perioperative space 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, and anti-inflammation. The company is committed to serving patients and medical staff around the world.