Cali Biosciences Announces Successful Results in Phase IIb Study of Long-Acting Ropivacaine (CPL-01) for Non-Opioid Treatment of Post-Operative Pain
Cali Biosciences, a biopharmaceutical company focused on the research and development of innovative drugs, announced successful results in its Phase IIb study of its perioperative long-acting analgesic product CPL-01.
CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by Cali Biosciences to treat post-operative surgical pain and reduce the need for opioids. This Phase IIb clinical trial was designed to further investigate the clinical advantages of CPL-01 and to compare with those of existing pain management drugs on the market. The trial demonstrated an excellent dose-response for efficacy. In the dose currently planned as the to-be marketed dose, 14 subjects who received CPL-01 showed a mean AUC through 72 hours of wWOCF adjusted NRS-A (the primary endpoint) of 286.8, showing a trend towards significance against the 13 subjects who received placebo (p=0.08) and substantially better than the 40 subjects who received Naropin®. Clinical meaningfulness was demonstrated by showing a difference of more than one AUC point per hour.
Additionally, opioid use through 72 hours of the CPL-01 subjects who received the to-be marketed dose was cut in half compared to either the placebo group or the Naropin® group (mean of 7.9 mg, as opposed to 15 mg for placebo and 16 mg for Naropin®). In fact, approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all after the first 72 hours after the operation, compared to roughly half of the Naropin® subjects and 30% of the placebo ones.
There were no meaningful safety findings; the only treatment emergent adverse events that occurred in more than one CPL-01 subject across all cohorts within the trial (n=40) were nausea, vomiting, constipation, headache parasthesia, and dizziness – all events that commonly occur after surgery and may occur after opioid usage; none of these were thought to be related to CPL-01.
The pharmacokinetics of the drug further supported its safety – the primary reason that a long-acting ropivacaine is being developed, with potential advantages over currently available long-acting bupivacaine. The mean Cmax for ropivacaine in subjects who received the 600 mg dose was 978 ng/mL, much lower than the threshold where cardiac toxicity can be seen (4000 ng/mL). CPL-01 reached its maximums concentration approximately 18 hours after administration, as opposed to Naropin® (which reaches it within the first hour after administration).
Dr. Todd Bertoch, an anesthesiologist who has participated in the trials of other prior long-acting local anesthetics and a principal investigator in this study, said, "These results are incredibly exciting, and say to me that, with successful completion of this Phase II study, Cali Biosciences is leading the way to produce the first long-acting ropivacaine for patients." Dr. Erol Onel, Chief Medical Officer at Cali Biosciences US who has developed several other long-acting local anesthetics, agreed, "Ropivacaine is generally considered to be one of the safest local anesthetics, so developing a long-acting version of it seemed like the common-sense next step in the evolution of post-operative pain control."
PJ Chen, Chief Executive Officer of Cali Biosciences, commented, "CPL-01 is the core product of Cali Biosciences' product pipeline in perioperative analgesia, anesthesia, and anti-inflammation drug solutions. Given our prior successful results in abdominoplasty, these results further enhance our confidence 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. We look forward to serving more doctors and patients worldwide."
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