SAN DIEGO, November 19, 2021 / PRNewswire / – Cali Biosciences, a global biopharmaceutical company focused on the research and development of innovative drugs, today presented Phase IIa clinical data on its long-acting perioperative ropivacaine, CPL-01, at the 20th annual edition of the American Society of Regional Anesthesia and Pain Medicine Meeting (ASRA).
CPL-01 is a sustained-release injectable version of ropivacaine hydrochloride developed by Cali Biosciences to treat postoperative surgical pain and reduce the need for opioids. The Phase IIa clinical trial of CPL-01 in Tummy Tuck is a randomized, double-blind, placebo-controlled study to assess the safety and pharmacokinetic profile in the management of acute postoperative pain.
In this first human study, CPL-01 demonstrated sustained-release PK characteristics, with the ability to provide local anesthetic (LA) and analgesia while maintaining placebo-like safety.
Dr. Erol One, Medical Director of Cali Biosciences, said: âThe data demonstrate the safety and promising pharmacokinetic profiles of CPL-01. This is a strong indication of the international recognition of the anesthesia community of the potential of CPL-01 as a new treatment option for long-acting perioperative analgesia. . ”
âThe Phase IIa result presented at the 20th ASRA Annual Meeting shows the therapeutic potential of CPL-01. We will move forward at full speed with the clinical program in the hope of bringing a new treatment option to patients around the world. Said PJ Chen, CEO of Cali Biosciences.
About the CPL-01
CPL-01 is a sustained release injectable formulation of NaropinÂ® (ropivacaine hydrochloride), which is in the aminoamide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and the management of acute pain. While NaropinÂ® (ropivacaine hydrochloride) is approved for local or regional anesthesia in surgery and for the management of acute pain, its short duration limits its effect. As a result, Cali Biosciences developed CPL-01, based on NaropinÂ® Injection and PG-Depot technology, to extend its duration.
About Cali Biosciences
Cali Biosciences Co., Ltd. was created in Cayman Islands in 2021 as the parent company of Cali Pharmaceuticals, LLC, a main subsidiary of the Cali Group which was established in San Diego, United States, in 2016, and then built its global headquarters in Shenzhen and a clinical development center in Shanghai, China. Cali Biosciences is an innovative international biopharmaceutical company with a number of independent licensed research and development technology platforms, as well as an international scientific research and management team. It is engaged in the R&D, production and sale of clinical and innovative drugs in the perioperative surgical field in order to fully meet the unmet clinical and market needs. Cali Bioscience’s product portfolio includes modified formulations and new drugs in the areas of anesthesia, analgesia, anti-inflammatory and anti-infectives. The company is committed to serving patients and medical staff around the world.
SOURCE Cali Biosciences