Cali Biosciences Announces Publications of Phase IIa Results of Long-Acting Ropivacaine (CPL-01)

CPL-01, for Non-Opioid Treatment of Post-Operative Pain, Garners Publication of Clinical Data in Abdominoplasty and Presentation of Preclinical Data in Bony and Soft-Tissue Models Supporting Pharmacokinetics and Safety

SAN DIEGO, Oct. 26, 2022 /PRNewswire/ -- Cali Biosciences Co., Ltd. (hereinafter referred to as "Cali Biosciences"), a biopharmaceutical company focused on the research and development of innovative drugs, announced two major milestones for CPL-01, its long-acting ropivacaine for post-operative analgesia and opioid elimination/reduction:

1. Publication of "CPL-01, an Investigational Long-Acting Ropivacaine, Exhibits Extended-Release Properties after Mini-abdominoplasty" in a peer-reviewed medical journal, Japan Journal of Medicine.
2. Presentation of preclinical data at the prestigious American Association of Pharmaceutical Sciences "Pharma 360" Annual Meeting, confirming the tolerability and duration of CPL-01 in both soft tissue surgery and bony tissue surgery.

CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by Cali Biosciences to treat post-operative surgical pain and reduce or eliminate the need for opioids. The publication in Japan Journal of Medicine confirmed that the trial demonstrated long-acting pain control and opioid reduction, while further supporting the safety and efficacy of CPL-01.  Hanghang "Tommy" Xu, Cali's Head of Clinical Research for Asia, stated, "The benefits of ropivacaine over bupivacaine are well supported in the literature, so the benefits of ropivacaine as the anesthetic of choice in a long-acting analgesic product are self-evident."  Dr. Ira Gottlieb, the PI on the study and a co-author on the manuscript, agreed:  "While long-acting bupivacaines have started to hit the market over the past decade, this is the most advanced long-acting ropivacaine and could be a game-changer."  The article itself is available via the following reference:  Hanghang Tommy Xu, Lee Chen, PJ Chen, Christine Pan, Erol Onel, Ira J Gottlieb. CPL-01, an Investigational Long-Acting Ropivacaine, Exhibits Extended-Release Properties after Mini-abdominoplasty. Japan Journal of Medicine. 2022; 5(1): 508- 515. doi: 10.31488/JJM.169.

Additionally, the presentation at the AAPS confirmed that across multiple species and multiple models, in both soft tissue surgeries and bony surgeries, CPL-01 demonstrated extended-release characteristics without evidence of local toxicity.  William Nappier Cherup, presenter of the poster, explained, "The assessment of systemic exposure, along with the lack of any signal regarding local tolerance, systemic toxicity, or bone healing supports moving forwards with CPL-01 as a newer, safer long-acting local analgesic."  Dr. Erol Onel, Chief Medical Officer of Cali Biosciences US, LLC, added that several of the recently introduced long-acting local analgesics did not come to market with a broad label and that "Recent FDA guidance documents from earlier this year support confirming safety, efficacy, and pk in soft tissue and bony models – this is an incredibly important step" in the path to helping patients after any surgery recover in an opioid-free manner.

PJ Chen, Chief Executive Officer of Cali Biosciences, commented, "CPL-01 is the core product of Cali Biosciences' product pipeline in our perioperative program, which also includes anesthetics, and long-acting anti-inflammatories. Given our prior successful results, we remain confident that CPL-01 will meet the unmet clinical needs, and provide a new and better option for doctors and patients seeking post-operative pain management – including opioid reduction or elimination. We look forward to serving more doctors and patients worldwide."

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, the Cali Biosciences 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. Cali Biosciences US, LLC was established in San Diego, USA, in 2016, and later Cali Biosciences built its global headquarter in Shenzhen and a Clinical Development Center in Shanghai, China. 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 clinical and Innovative 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