SAN FRANCISCO--(BUSINESS WIRE)--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, announced today that it has initiated a Phase 2 clinical study of CA-008, the Company’s lead product candidate for the treatment of post-surgical pain. CA-008 is a water-soluble non-opioid prodrug that rapidly converts to capsaicin, a potent TRPV1-agonist which selectively desensitizes pain conducting nerve fibers to provide long-lasting analgesia.
Concentric’s CA-008 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, dose ranging study in patients undergoing bunionectomy. The primary objective of the study is to evaluate efficacy and safety of a single dose of CA-008 at different dose strengths versus placebo. Data from this clinical trial are expected to serve as the basis for dose selection in future clinical studies.
In a recently completed Phase 1b placebo-controlled clinical trial in patients undergoing bunionectomy, CA-008, in addition to demonstrating safety and tolerability at all doses, showed at the highest dose a statistically significant and clinically meaningful 63% reduction of pain intensity for area under the curve (AUC) 0-168h, statistically significant milestone reductions of pain at 48h, 72h, 96h and 120h, and nearly a 50% reduction in opioid consumption.
“Our first-in-human P1b bunionectomy study demonstrated that CA-008 can be administered safely to surgical patients, and the strong signal of efficacy supports its unique and compelling therapeutic profile. CA-008 has the potential to dramatically improve patient recovery and outcomes by providing long-lasting pain relief during the immediate post-operative period and throughout outpatient recovery,” said Mike A. Royal, MD, Chief Medical Officer of Concentric Analgesics. “Initiating a larger Phase 2 study is the next step in advancing our clinical development program to bring CA-008 to market.”
Concentric expects to announce top-line results from the Phase 2 clinical trial by the end of the year. More information about the trial can be found at www.clinicaltrials.gov.
About Opioid Addiction & Post-Surgical Pain
Opioid addiction in the United States has reached epidemic proportions, destroying families, lives and communities throughout the country. New approaches for preventing this insidious disease are imperative, including in the post-surgical setting, which can be an unsuspecting gateway to prescription pain medicine abuse and beyond. A 2016 US News & World Report revealed that one in 10 patients report becoming addicted or dependent on opioids following surgery. With more than 100 million surgeries being performed in the US in 2017, 30 million of which require post-surgical pain management with non-over the counter (OTC) pain medications, the mandate to develop safe and effective non-opioid alternatives is clear.
About CA-008
Concentric Analgesics’ lead product candidate for post-surgical pain is CA-008. The compound is a proprietary water-soluble prodrug that converts into capsaicin – the naturally occurring molecule that gives chili peppers their heat. Capsaicin, a potent TRPV-1 agonist which has a long history of use as a topical analgesic, selectively and reversibly desensitizes pain conducting nerve fibers (C-fiber nociceptors). TRPV-1 agonism evokes an initial neuronal excitation that is followed by a durable refractory state to provide long-lasting analgesia.
About Concentric Analgesics
Concentric Analgesics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on discovering and developing novel, non-opioid therapeutics for the management of acute and chronic pain. The Company’s core proprietary technology is the foundation of a broad portfolio of patented TRVP1-agonist prodrugs. In addition to its flagship post-surgical pain program with CA-008, the Company also has pre-clinical development programs in refractory cancer pain and osteoarthritis pain.
For more information, please visit www.concentricanalgesics.com.