May 14, 2018
Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, today announced topline results from its Phase 1b clinical trial for CA-008 in post-surgical pain. The primary objective of the clinical study was to demonstrate the safety and pharmacokinetics of CA-008, with secondary endpoints including efficacy. The study showed that CA-008, a novel, non-opioid therapeutic, was well tolerated at all dose levels compared to the control group following surgery in bunionectomy patients. Although the study was not powered for efficacy, the highest dose cohort of CA-008 showed statistically significant and clinically meaningful (greater than 50%) reductions in area under the curve (AUC) for pain intensity compared to the control group lasting up to 168 hours.
Apr 3, 2018
Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, announced today that it has appointed Susan Kramer, DrPH, Executive Vice President, Program Management & Strategy and Mike A. Royal, MD, Chief Medical Officer. Drs. Kramer and Royal collectively bring more than 50 years of senior biopharmaceutical development experience leading multiple first-in-class therapeutics through market approval.
Dec 7, 2017
Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CA-008 for the treatment of post-surgical pain. CA-008 is a proprietary water-soluble prodrug that converts into capsaicin, a potent TRPV-1 agonist.
Fast Track is a designation by the FDA designed to facilitate the development and expedite the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need. Its purpose is to get important new therapeutics to the patient earlier. Recipients receive an enhanced level of interaction and support from the FDA and there is a strong historical correlation between Fast Track designation and receiving priority review after filing an NDA.
Nov 2, 2017
Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, announced today that it has initiated a Phase 1b clinical trial with CA-008, a proprietary water-soluble prodrug that converts into capsaicin, a potent TRPV-1 agonist. Results from this clinical trial are expected in the first quarter of 2018.
The Phase 1b study is a randomized, double-blind clinical trial, targeting approximately 32
patients undergoing bunionectomy. The goal of the single, ascending-dose trial is to examine the safety, tolerability and pharmacokinetics of CA-008.
Oct. 17, 2017
Concentric Analgesics, Inc., a development-stage biopharmaceutical pain company, announced today that it has appointed Thomas B. King to its Board of Directors. Mr. King brings nearly 40 years of leadership experience building, operating and selling multiple biopharmaceutical businesses.
“Tom brings significant strategic development, regulatory and commercialization experience to the Concentric Analgesics board, which will be valuable as we advance our lead program, CA-008, in post-surgical pain to the clinic, and look to commence IND-enabling studies for CA-011, our osteoarthritis pain program,” said John Donovan, M.D., Chief Executive Officer of Concentric Analgesics. “We are thrilled to have Tom join the Concentric team, particularly at such a transformative time for the company.”