Cali Biosciences Initiates Second Phase III Study of CPL-01 (Long-Acting Ropivacaine) to Decrease Post-Operative Pain and Reduce or Eliminate Opioid Use and Presents Consistent and Predictable PK Results Across Multiple Surgeries

• Subjects in Bunionectomy Study Dosed 
• Data Presented at American Society for Pharmacology and Experimental Therapeutics Shows Similar Ropivacaine Pharmacokinetic Curves From CPL-01 Across Multiple Surgeries; Minimal Variability as Compared to Liposomal Bupivacaine

SAN DIEGO, June 5, 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 that its second Phase III study of its core product, CPL-01 (long-acting ropivacaine), has begun with dosing in bunion patients.  This study is in addition to the hernia repair study initiated last month, and is expected to help fulfill regulatory requirements of a broad indication.

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. Grant Garbo, investigator at the site where the first subject was dosed, said, "The importance of CPL-01 in bony surgery cannot be overstated – knowing how well Cali's product has performed in Phase II, I really look forward to helping CPL-01 showcase its excellent results and safety profile in Phase III."

Cali also announced that the poster presentation "CPL-01, A Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Systemic Exposure" was well received at the American Society for Pharmacology and Experimental Therapeutics Annual Meeting this past weekend.  Ms. Stevie Pope, lead author on the paper, commented "the fact that CPL-01 showed a similar shaped curve and a predictable median Tmax at 8-12 hours across multiple surgical models should reassure physicians – this contrasts dramatically with data published on liposomal bupivacaine, where the curves are shaped quite differently and the median Tmax can vary from under an hour to more than a day." 

Dr. Erol Onel, Chief Medical Officer at Cali Biosciences US, LLC who has developed several other long-acting local anesthetics and is a co-author on the paper, agreed and stated, "Demonstrating consistent and predictable release characteristics directly addresses a frequent concern with available bupivacaine-based products: if the release characteristics in Surgery A are different from those in Surgery B, how can the existing efficacy and safety data from specific surgical procedures be generalized?  The data presented resoundingly show that this inconsistency is not present with CPL-01, which clearly supports its applicability across a broad spectrum of procedures."

Mr. PJ Chen, Chief Executive Officer of Cali Biosciences, commented, "Given that ropivacaine is considered safer than bupivacaine, we saw a need for a long-acting ropivacaine rather than the bupivacaines currently available. We are confident that the phase III results in both bunion and hernia will build on our successful Phase II results, so that 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. Cali is positioned to be a leader in the peri-operative space as CPL-01 and our other pipeline products proceed, so that we can help patients world-wide."

About CPL-01

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.

About Cali Biosciences

Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarters in Shenzhen and established a research and development team in Shanghai. Cali Biosciences 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 innovative clinical drugs in the surgical perioperative field to fully respond to unmet clinical and market needs. Cali Biosciences' product pipeline includes modified formulations and new drugs in the fields of anesthesia, analgesia and anti-inflammatory. The company is committed to serving patients and medical staff around the world.

SOURCE Cali Biosciences