Concentric Analgesics, Inc.

AMSTERDAM--( BUSINESS WIRE )--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company developing novel, non-opioid pain therapeutics, today announced a poster presentation of additional favorable clinical data for vocacapsaicin, its first-in-class lead product candidate for the management of postsurgical pain, at the 2024 International Association for the Study of Pain (IASP) World Congress being held August 5- 9, 2024 in Amsterdam, Netherlands. The presentation “TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation” includes data from previously announced results of vocacapsaicin in Phase 2 trials for patients undergoing total knee arthroplasty (TKA) and bunionectomy. Both studies were multi-center, randomized, controlled clinical trials measuring postsurgical analgesia and opioid consumption following a single intra-operative administration of vocacapsaicin. Vocacapsaicin is an innovative, water-soluble prodrug of capsaicin. Vocacapsaicin rapidly releases capsaicin at the surgical site after a single local administration during surgery which triggers activation of the TRPV1 receptor on pain-specific nerves. TRPV1 activation is known to produce analgesia that lasts for weeks to months without causing sensory numbness or motor weakness. This is a highly differentiated mechanism of action from local anesthetics, such as bupivacaine including extended-release formulations, which are shorter-acting and produce sensory numbness and motor weakness. In the poster, separate trials in bunionectomy and total knee arthroplasty are presented showing durable analgesia that lasted for two weeks with reduced opioid usage and earlier opioid cessation following both surgeries. The data from the bunionectomy trial were recently published in the August issue of the journal ANESTHESIOLOGY, while this is the first presentation of the data on opioid cessation from the TKA trial. Following bunionectomy, all patients receiving an effective dose of vocacapsaicin were able to stop opioid analgesic medication by 5 days compared to 16% in the placebo group who still required opioids, half of which were still using opioids at the end of the two-week study. The differences were statistically significant. At two weeks following total knee arthroplasty, 50% more patients in the placebo group still required opioid analgesia compared to the vocacapsaicin group (58% vs 38%, respectively). The difference was also statistically significant. The risk of persistent opioid use, a known risk factor for opioid dependence and abuse, increases most sharply in patients who continue taking opioids after five days. The United States Congress recently passed the Non-Opioids Prevent Addiction in the Nation (NO PAIN) Act, set to go into effect January 2025, which will increase patient and provider access to non-opioid pain management options by removing the barriers associated with reimbursement for the Medicare population. Harold Minkowitz, M.D., President of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC, an Evolution Research Group portfolio company and an investigator in both studies stated, “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia. This distinct property allows for earlier cessation of opioids, an effect that has not been seen before with a single drug administration. If approved, vocacapsaicin will revolutionize post-operative pain management.” “The results of both studies are impressive,” said Edwin Su, M.D., Attending Orthopedic Surgeon, Hospital for Special Surgery and Professor of Orthopedic Surgery, Weill Cornell Medical College. “The TKA data is particularly important given that pain after joint replacement can last for weeks. The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks. Vocacapsaicin has the potential to be an important addition to care pathways and meaningfully improve patient recovery after joint replacement.” John Donovan, M.D., Founder and Chief Scientific Officer at Concentric Analgesics, noted, “In 2018, vocacapsaicin received Breakthrough Therapy Designation from the FDA for its effect on reducing opioid usage. The data from these two trials covering a variety of clinically meaningful opioid endpoints extend our understanding about the impact of vocacapsaicin on opioid reliance after surgery and have us well-positioned for Phase 3 trials and bringing a much needed innovative therapeutic to patients.” Presentation details are below: Title: TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation Date and time: August 6, 2024 at 3:15 PM (local time) Poster number: TU509 Lead author: Sam Teichman, M.D., Head of Clinical Development, Concentric Analgesics Presenter: Ben Vaughn, M.S., RAC, Chief Strategist Biostatistics and Protocol Design at Rho The poster is available on the meeting website: https://posters.worldcongress2024.org/poster/trpv1-bench-to-bedside-vocacapsaicin-causes-durable-postsurgical-analgesia-earlier-opioid-cessation/ Data from the bunionectomy trial appears in the August issue of the journal ANESTHESIOLOGY , Opioid Use and Abuse After Painful Surgery Effective management of pain after surgery remains an unmet medical need. More than 30 million surgeries are performed in the U.S. annually that require prescription drugs for pain management. Oral opioid analgesics remain an integral part of postsurgical pain management despite common side effects, safety concerns, and the risk of persistent opioid use which can lead to abuse and beyond. According to the Centers for Disease Control and Prevention, more than 80,000 Americans died from opioid overdoses in 2022 – more than the annual total number of deaths from automobile accidents and gun deaths combined. About Vocacapsaicin (formerly CA-008) Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent and well-studied TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers. Vocacapsaicin has the potential to reduce or even 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 and Breakthrough Therapy Designation from the US 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 planning Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional programs for osteoarthritis pain and chronic refractory pain. For more information, please visit: www.concentricanalgesics.com .

Data on vocacapsaicin suggest significant post-surgery pain relief, preventative of opioid dependency. Image: Shutterstock / FGC. California-based biopharmaceutical company Concentric Analgesics announced they will present data today (6 August) on their novel pain management drug vocacapsaicin, highlighting pain relief and early opioid cessation. The poster presentation, to be given at the International Association for the Study of Pain (IASP) World Congress in Amsterdam, NL, includes new Phase II data on opioid cessation with vocacapsaicin following total knee arthroplasty (TKA) (NCT03731364). The trial found that two weeks following TKA, 38% of patients receiving the drug required opioid-based analgesia compared to 58% of patients in the placebo group. CEO Frank Bellizzi told Pharmaceutical Technology that Concentric has a further, “four clinical studies” planned for vocacapsaicin, and that, “the first three studies have been cleared by the FDA.” He added that Concentric is “currently seeking to forge commercial partnerships.” Also included in today’s presentation will be data from a Phase II trial investigating vocacapsaicin following bunionectomy (NCT03599089). These data, published in Anesthesiology , demonstrated that vocacapsaicin enabled opioid use cessation by 5 days post-surgery for all patients; this was achieved by only 16% of patients receiving placebo, half of whom continued opioid use at two weeks. This data is significant given the US’s opioid epidemic. The risk of persistent opioid use which can lead to addiction increases most significantly once use continues past 5 days. “The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks”, according to Edwin Su, MD, from Weill Cornell Medical College. See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Vocacapsaicin is a prodrug of capsaicin which releases its product locally. It triggers TRPV1 receptors on pain-specific nerves to induce long-lasting analgesia. Vocacapsaicin’s effects can last months without numbness or motor weakness. Harold Minkowitz, MD, from HD Research, notes “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia.” Vocacapsaicin received Fast Track designation from the US Food and Drug Administration (FDA) in 2017 and Breakthrough Therapy designation in 2018. In 2019, Concentric raised $76mn in Series B financing, and has raised $40mn in the past three years, as per GlobalData. GlobalData is the parent company of Pharmaceutical Technology . The drug could benefit from the Non-Opioids Prevent Addition in the Nations (NO PAIN) Act passed by the US congress and set to go into effect in January 2025. This would increase access to non-opioid pain management by removing reimbursement barriers for Medicare.

SAN FRANCISCO--( BUSINESS WIRE )--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company developing novel, non-opioid pain therapeutics, today announced publication of a multicenter, randomized clinical trial evaluating vocacapsaicin on the cover of the August 2024 issue of ANESTHESIOLOGY, the highest impact journal in the specialty. Results showed that a single dose of vocacapsaicin significantly reduced pain and opioid use for at least one week after bunionectomy, the most commonly studied model to assess and validate analgesic benefit for postsurgical pain. Vocacapsaicin is an innovative, water-soluble prodrug of capsaicin. Vocacapsaicin rapidly releases capsaicin at the surgical site after a single local administration during surgery which triggers activation of the TRPV1 receptor on pain-specific nerves. TRPV1 activation is known to produce analgesia that lasts for weeks to months without causing sensory numbness or motor weakness. This is a highly differentiated mechanism of action from local anesthetics, such as bupivacaine, which are short-acting and produce sensory numbness and motor weakness. In the Phase 2 study, 147 patients were randomized to receive one of three doses of intraoperative locally administered vocacapsaicin (0.30, 0.15 or 0.05 mg/ml) or placebo. All patients received identical perioperative analgesia. The prospective objective was to test the therapeutic benefit of the 0.30 mg/ml dose. Results of prespecified primary and key secondary endpoints for the 0.30 mg/ml group, compared to placebo control group, showed: 33% reduction in pain at rest during 0–Day 5 (p=0.005) 37% reduction in pain at rest during 0–Day 8 (p=0.004) 50% reduction in opioid consumption during 0-Day 5 (p=0.002) Five times as many patients receiving vocacapsaicin never needed any postoperative opioid analgesia compared to control (26% vs 5%, respectively, p=0.025). In addition, 100% of the vocacapsaicin group stopped opioids by Day 5 while 16% of the control group still required opioid analgesia at that time (p=0.001) 8% in control group continued to need opioids at Day 15 The analgesic effect of vocacapsaicin was persistent and consistently evident on each day throughout the two weeks following surgery A clear dose response was documented Vocacapsaicin appeared safe and well tolerated with no differences between groups in any safety parameter. The risk of persistent opioid use, a known risk factor for opioid dependence and abuse, increases most sharply in the initial days of treatment, particularly for patients who continue taking opioids after 5 days. Lead author, Steven L. Shafer, MD, Professor Emeritus, Stanford University School of Medicine and adviser to Concentric, said, “This is the first demonstration of a single intra-operative injection leading to earlier cessation of opioids after surgery. By targeting TRPV1 receptors, vocacapsaicin eclipses the duration of pain relief possible from local anesthetic formulations.” In his accompanying editorial, A Spicy New Treatment for Postoperative Pain , David Clark, MD, PhD, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University, stated, "Fundamental advancements in our field do not occur every day, so it is particularly exciting when early reports of innovative new treatments are published. The potential value of this type of treatment is enormous.” Eske K. Aasvang, MD, Professor of Anaesthesiology, Rigshospitalet Copenhagen and Chairman of the Danish Medicines Board’s National Guideline on Follow-up After Opioid Prescription, stated, “The most important finding in the vocacapsaicin studies by Concentric Analgesics is the reduced opioid consumption and, of particular significance, the earlier cessation. This drug gives us hope for fewer long-term opioid users and less of the all too frequent opioid-related severe adverse events including abuse and death." Michael D. Maloney, MD, Dean’s Professor of Orthopaedics, Chief of the Division of Sports Medicine, and Medical Director of the Ambulatory Surgery Center at University of Rochester Medical Center, said, “In addition to these data, I have been equally impressed by the Phase 2 data on the use of vocacapsaicin during total knee arthroplasty published in abstracts. Orthopedic surgeons want an easy-to-use, intra-operative non-opioid analgesic that can reduce pain during the full postsurgical recovery period, including rehabilitation.” “We are pleased that our Phase 2 study merited the cover of ANESTHESIOLOGY, along with the accompanying editorial, which we believe validates vocacapsaicin’s extraordinary potential clinical impact,” said Frank Bellizzi, chief executive officer of Concentric Analgesics. “Our plans to begin Phase 3 studies are largely completed and we remain deeply committed to bringing this innovative new treatment to patients and clinicians as quickly as possible.” The paper, editorial and supplemental infographics are available online: https://pubs.asahq.org/anesthesiology/article/141/2/250/140092/Safety-and-Efficacy-of-Vocacapsaicin-for Opioid Use and Abuse After Painful Surgery Effective management of pain after surgery remains an unmet medical need. More than 30 million surgeries are performed in the U.S. annually that require prescription drugs for pain management. Oral opioid analgesics remain an integral part of postsurgical pain management despite common side effects, safety concerns, and the risk of persistent opioid use which can lead to abuse and beyond. According to the Centers for Disease Control and Prevention, more than 80,000 Americans died from opioid overdoses in 2022 – more than the annual total number of deaths from automobile accidents and gun deaths combined. About Vocacapsaicin (formerly CA-008) Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent and well-studied TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers. Vocacapsaicin has the potential to reduce or even 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 and Breakthrough Therapy Designation from the US 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 planning Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional programs for osteoarthritis pain and chronic refractory pain. For more information, please visit: www.concentricanalgesics.com .