ASRA 2021 | Cali Biosciences Presents Phase IIa Clinical Data on CPL-01, a Long-Acting Ropivacaine
SAN DIEGO, Nov. 19, 2021 /PRNewswire/ -- Cali Biosciences, a global biopharmaceutical company focused on the research and development of innovative drugs, presented Phase IIa clinical data today on its perioperative long-acting ropivacaine, CPL- 01, at the 20th Annual American Society of Regional Anesthesia and Pain Medicine (ASRA) Meeting.
CPL-01 is an extended-release injectable version of ropivacaine hydrochloride developed by Cali Biosciences to treat post-operative surgical pain and reduce the need for opioids. The phase IIa clinical trial of CPL-01 in abdominoplasty is a randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacokinetic profile in the management of acute postoperative pain.
In this first-in-human study, CPL-01 demonstrated extended-release PK characteristics, with the ability to provide local anesthetic (LA) effect and analgesia while maintaining a safety similar to placebo.
Dr. Erol Onel, Chief Medical Officer of Cali Biosciences, said, "The data demonstrates CPL-01's promising safety and PK profiles. This is a strong indication of the international anesthesia community's recognition of CPL-01's potential as a new treatment option for perioperative long-acting analgesia."
"The Phase IIa result presented at the 20th Annual ASRA Meeting shows the therapeutic potential of CPL-01. We will move forward in full speed with the clinical program in the hope of bringing a new treatment option to patients worldwide." said PJ Chen, Chief Executive Officer of Cali Biosciences.
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. While Naropin® (ropivacaine hydrochloride) is approved for local or regional anesthesia for surgery and for acute pain management, its short duration limits its effect. As a result, the Cali Biosciences developed CPL-01, based on Naropin® Injection and PG-Depot technology, to prolong its duration.
About Cali Biosciences
Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021 as the parent company of Cali Pharmaceuticals, LLC, a principal subsidiary of the Cali Group which was established in San Diego, USA, in 2016, and later 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 Bioscience's product pipeline includes modified formulations and new drugs in the fields of anesthesia, analgesia, anti-inflammatory and anti-infection. The company is committed to serving patients and medical staff around the world.
SOURCE Cali Biosciences