Concentric Analgesics Announces Poster Presentation of Positive Vocacapsaicin Data from Total Knee Arthroplasty Phase 2 Study at the 2021 American Academy of Hip and Knee Surgeons Annual Meeting

Concentric Analgesics, Inc. today announced the poster presentation of clinical data for vocacapsaicin, its first-in-class non-opioid lead product candidate for the management of postsurgical pain, at the 2021 American Academy of Hip and Knee Surgeons ("AAHKS") Annual Meeting in November in Dallas, Texas.

This was the first scientific presentation to orthopedic surgeons of the positive results from the recently completed Phase 2 clinical trial in patients undergoing total knee arthroplasty ("TKA").

The study demonstrated that a single dose of peri-articular vocacapsaicin at 36 mg and ropivacaine administered during surgery achieved statistically significant and clinically meaningful reductions in pain and opioid use continuously through two weeks following surgery compared to ropivacaine and placebo. Mean opioid consumption during the inpatient observation period (0-96h) was reduced by 30% (p<0.0001) and this improved further to a 52% reduction in opioid consumption over the 10 days (96h-Day 15) following discharge (p=0.0063). The reductions in both the amount and duration of opioid use were achieved even though all patients received standard of care, multi-modal, non-opioid analgesics after discharge. In addition, 90% of patients that received vocacapsaicin 36 mg were able to walk 100 feet on post-op Day 3 compared to 63% in the control group (p=0.003). Adverse events and other assessments appeared comparable to placebo, indicating an acceptable safety profile.

"The results of this study are impressive," said Edwin Su, M.D., Attending Orthopedic Surgeon, Hospital for Special Surgery and Professor of Orthopedic Surgery, Weill Cornell Medical College. "Vocacapsaicin's therapeutic effect was clinically meaningful across multiple endpoints. The combination of earlier ambulation and two weeks of reduced opioid consumption will likely translate into earlier discharge, faster recovery, and fewer callbacks. If confirmed in future studies, vocacapsaicin has the potential to be an important addition to TKA care pathways and meaningfully improve patient recovery after joint replacement."

"AAHKS is the pre-eminent group of orthopedic surgeons that perform hip and knee replacement," said John Donovan, M.D., Chief Scientific Officer for Concentric Analgesics. "AAHKS received 1,430 abstracts and we were pleased to be selected as part of their annual meeting. Our presentation increased awareness and generated interest on the promise and potential of vocacapsaicin, our novel drug candidate for the management of postsurgical pain."

Details of the online poster presentation are provided below.

Presentation title: Vocacapsaicin Reduces Pain and Opioid Consumption for Two Weeks Following a Single Administration During Total Knee Arthroplasty

Meeting: 2021 American Academy of Hip and Knee Surgeons Annual Meeting

Abstract number: A10402

Poster number: 120

Link to poster: https://aahks.apprisor.org/index.cfm?k=iglfm8udfs

Lead author: Sam Teichman, M.D., Head of Clinical Development, Concentric Analgesics

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 into the surgical site 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 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.