Cali Biosciences Publishes Successful Phase 2 Hernia Study Results

SAN DIEGO, May 21, 2024 – Cali Biosciences Co., Ltd., a prominent biotechnology firm, has announced the publication of a significant study on their investigational long-acting ropivacaine, CPL-01, in the scientific journal Hernia. The research investigates the drug's safety and effectiveness in open inguinal hernia repair. The study is co-authored by Hanghang Tommy Xu, John Zimmerman, Todd Bertoch, Lee Chen, PJ Chen, and Erol Onel.

Dr. Tommy Xu, the lead author, emphasized the importance of this recognition by Hernia, noting the investigational drug CPL-01’s superior performance compared to both the placebo and the standard of care, Naropin®. He highlighted that CPL-01 resulted in a meaningful reduction in pain over 72 hours, even with half the amount of opioids. Dr. Erol Onel, Chief Medical Officer of Cali Biosciences US, LLC, pointed out that while many long-acting local anesthetics currently available are based on bupivacaine, CPL-01 is based on ropivacaine, which is considered safer.

Dr. Todd Bertoch, the study’s principal investigator, confirmed CPL-01's safety, mentioning the absence of serious adverse events in the doses advanced to Phase 3 trials. He also stressed the benefits of a more effective and safer long-acting local anesthetic, underscoring its potential to reduce severe pain and support opioid-free recovery, which would benefit patients, healthcare systems, and society at large.

PJ Chen, CEO of Cali Biosciences, expressed optimism about the results from the ongoing Phase 3 trials and the anticipated positive feedback from regulatory authorities. He also mentioned the encouraging outcomes from a soon-to-be-published Phase 2 bunion study. According to Chen, these advancements, combined with other pipeline products, position Cali Biosciences as a leader in the peri-operative space, aiming to serve both doctors and patients globally.

CPL-01 is an extended-release injectable form of Naropin® (ropivacaine hydrochloride), an amide-class local anesthetic used for surgical anesthesia and acute pain management. Traditional Naropin® injections require catheter infusion for prolonged effects due to their short duration. Cali Biosciences has utilized the PG-Depot drug delivery platform to develop CPL-01, which extends the local analgesic effect with a single administration.

Cali Biosciences Co., Ltd. was founded in the Cayman Islands in 2021, with its US branch established in San Diego in 2016. The company has since moved its global headquarters to Shenzhen. Cali Biosciences is focused on developing pain management drugs using its proprietary drug delivery platforms and technologies. Their product pipeline is centered on non-opioid postoperative pain management, including analgesia, anesthesia, sedation, and inflammation control. The company is dedicated to addressing unmet medical needs and serving medical professionals and patients worldwide.