SAN FRANCISCO–(BUSINESS WIRE)– Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, today announced two important Phase 3 clinical relationships for its lead product candidate, vocacapsaicin.

First, the company has entered into a formal agreement with Evolution Research Group (ERG), a leading postsurgical pain clinical research site network in the U.S., to conduct its registration trials.

“Following our experience with vocacapsaicin in the Phase 2 studies, we are excited for the potential to reproduce these efficacy and safety results in the Phase 3 studies,” said Harold Minkowitz, M.D., president of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC, an Evolution Research Group portfolio company. “Our patients are in great need of effective non-opioid pain management options, and we are highly confident that this can be achieved with vocacapsaicin.”

In addition, Concentric announced a multi-faceted collaboration with the University of Rochester Medical Center (URMC), a world-class center in the research, development and use of the latest orthopedic surgery products and techniques. URMC will participate in the vocacapsaicin Phase 3 clinical trials and develop innovative methods to capture vocacapsaicin’s benefit to patient recovery and rehabilitation.

“The therapeutic profile demonstrated by vocacapsaicin in the Phase 2 total knee arthroplasty (TKA) study is compelling and is ideally suited for the vast majority of orthopedic surgeries,” said Michael D. Maloney, M.D., dean’s professor of orthopaedics, chief of the division of Sports Medicine, and medical director of the Ambulatory Surgery Center at URMC. “A therapeutic that can minimize or eliminate the need for opioids in the postsurgical and rehabilitation periods would provide tremendous clinical and societal impact. If the clinical benefits already seen in TKA can be extended to other orthopedic procedures, vocacapsaicin has the potential to become a new standard of care.”

“We are thrilled to be working with these high caliber institutions as we prepare to initiate our pivotal studies,” said Susan Kramer, DrPH, executive vice president of development at Concentric Analgesics. “The unmatched quality and scale of ERG’s surgical site network, combined with the wide-ranging and deep expertise of URMC, will be instrumental to the successful execution of vocacapsaicin’s Phase 3 program.”

2021 Nobel Prize Awarded to Discoverers of the TRPV1 Receptor, the Target for Vocacapsaicin

The 2021 Nobel Prize in Physiology or Medicine was awarded to Professor David Julius of UCSF and Professor Ardem Patapoutian of Scripps Research for their discoveries of receptors for temperature and touch. Professor Julius’ work has focused on how our bodies sense heat, cold, and chemical irritants, leading to new insights about the fundamental nature of pain and new targets for pain therapy, including the TRPV1 receptor, commonly known as the “capsaicin” receptor.

“We congratulate Professor Julius and his team at UCSF on this award and their extraordinary contributions to science and medicine,” said John Donovan, M.D., chief scientific officer at Concentric Analgesics. “Our portfolio of TRPV1 agonist prodrugs, including vocacapsaicin, builds on their fundamental discoveries and has the potential to revolutionize pain management.”

About Vocacapsaicin (CA-008)

Concentric Analgesics’ lead product candidate for postsurgical pain is a proprietary 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 into the surgical site as an aqueous solution during surgery, has the potential to reduce or 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 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, approximately 70,000 Americans died from opioid overdoses in 2020 – 66% more than the total number of deaths from automobile accidents. New approaches for preventing this insidious disease are imperative, including in the postsurgical 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 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 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. Vocacapsaicin is the company’s Phase 3-ready lead product candidate for postsurgical pain. Concentric has two additional active programs for osteoarthritis pain and chronic refractory pain. For more information, please visit the company’s website at: www.concentricanalgesics.com.

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