Concentric Analgesics Announces Positive Results from Pilot Phase 2 Clinical Trial of Vocacapsaicin in Open Laparotomy for Repair of Abdominal Ventral Hernia

Data to be Presented at Upcoming Annual ASRA Meeting

SAN FRANCISCO–(BUSINESS WIRE)–Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, today announced positive results from its recently completed pilot Phase 2 clinical trial of vocacapsaicin in patients undergoing open laparotomy for ventral hernia repair. Vocacapsaicin is a first-in-class, non-opioid, long-lasting therapeutic with FDA Breakthrough Therapy Designation that is administered as a single dose during surgery. The primary objectives of the study, conducted in 24 patients, were to evaluate the effects of vocacapsaicin over 7 days on reported pain with activity, pain at rest, and opioid consumption, as well as safety and pharmacokinetics.

The pilot study showed that vocacapsaicin, administered during surgery at a dose of 24 mg (0.3 mg/mL solution), reduced pain after coughing by 46% compared to the placebo control during the first 96 hours after surgery (p=0.02). In addition, pain with ambulation was reduced by 35% (p=0.08). Similar positive trends were seen in the reduction of pain at rest and reduction of opioid consumption. Furthermore, these efficacy trends were still evident for 7 days following surgery. Vocacapsaicin generally appeared safe and well tolerated compared to the control group.

The company will present the detailed clinical data at the 47^th Annual Regional Anesthesiology and Acute Pain Medicine (“ASRA”) Meeting on March 31, 2022, in Las Vegas, Nevada. The spring ASRA meeting is the premier meeting for regional anesthesia and pain medicine.

“I have been following the clinical progress of this impressive product candidate. The data from this abdominal surgery study, coupled with the prior positive results from total knee arthroplasty and bunionectomy surgery, suggest that vocacapsaicin may be efficacious in addressing pain following a variety of surgeries, including both soft tissue and orthopedic surgery,” said Alparslan Turan, M.D., Professor of Anesthesiology at Lerner College of Medicine of Case Western University and Vice Chair of the Department of Outcomes Research at the Cleveland Clinic, the largest single-center clinical research group in the field of anesthesiology. “The need for non-opioid pain medicine in the postsurgical setting cannot be overstated, and vocacapsaicin has the potential to fulfill that need.”

“Given the increased focus on reducing opioid consumption and accelerating mobilization following surgery, managing pain during activity has become a high priority for clinical care,” said Sam Teichman, M.D., Head of Clinical Development at Concentric Analgesics. “The results of this study provide an indication of the potential for vocacapsaicin to manage pain across a number of evaluated activity parameters, and also provide guidance for our open laparotomy pivotal study.”

Details of the ASRA presentation are provided below.

• Presentation title: Pilot study of vocacapsaicin for treatment of pain following open laparotomy repair of ventral hernia
• Meeting: ASRA Annual Meeting, March 31 – April 2, 2022, Las Vegas, Nevada (https://www.asra.com/events-education/ra-acute-meeting)
• Abstract number: 2923
• Date and Session: March 31, 2022, 8:15 AM – 9:45 AM PT; Moderated session MP-01a
• Lead author: Sam Teichman, M.D., Head of Clinical Development, Concentric Analgesics
• Presenter: Harold Minkowitz, M.D., President of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC, an Evolution Research Group portfolio company

The poster will be available on the ASRA website and on the Concentric Analgesics website shortly after the presentation.

About Opioid Addiction & Postsurgical Pain

Opioid addiction in the United States has reached epidemic proportions, destroying families, lives and communities throughout the country. According to the Centers for Disease Control and Prevention, over 90,000 Americans died from opioid overdoses in 2020 – more than the annual total number of deaths from automobile accidents and gun deaths combined. New approaches for preventing this insidious disease are imperative, including in the postsurgical setting, which can be a significant 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 performed in the U.S. in 2017, 30 million of which required postsurgical pain management with products that were not over-the-counter (OTC) drugs, the mandate to develop safe and effective non-opioid alternatives is clear.

About Vocacapsaicin (CA-008)

Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers without producing sensory numbness or motor weakness. Vocacapsaicin, injected as an aqueous solution during surgery, has the potential to reduce, and in some patients, eliminate the need for opioids in the postsurgical recovery period and provide clinically meaningful pain relief for two weeks. Vocacapsaicin has received both Fast Track Designation (2017) and Breakthrough Therapy Designation (2018) from the U.S. Food and Drug Administration.

About Concentric Analgesics

Concentric Analgesics is a clinical-stage, biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics. The company’s portfolio of proprietary products is designed to provide long-lasting, selective pain relief after a single local administration. The company is initiating Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional active programs for indications with significant unmet medical need: osteoarthritis pain and chronic refractory pain. For more information, please visit the company’s website at: www.concentricanalgesics.com.

Contacts

Frank Bellizzi

Chief Executive Officer

Concentric Analgesics, Inc.

[email protected]