vocacapsaicin (CA-008) / Concentric Analgesics - LARVOL DELTA

TRPV1 bench to bedside-Vocacapsaicin causes durable postsurgical analgesia, earlier opioid cessation (IASP 2024) - "Two randomized, controlled trials in TKA and bunionectomy demonstrated that a single administration of vocacapsaicin 0.3 mg/mL during surgery improved analgesia for 2 weeks, decreased opioid use, improved functional recovery, and allowed patients to stop taking opioids sooner compared to placebo. Further studies are warranted."

Anesthesia • Orthopedics • Pain • TRPV1

Intra-treatment hypoxia directed major radiation de-escalation as definitive treatment for human papillomavirus-related oropharyngeal cancer. (ASCO 2024) - P2 | "Research Funding: NIH R01 CA238392-02A1NCI Cancer Support GRANT P30 CA008, DIMON HPV Foundation, Serra Initiative on the Management of Head and Neck Cancer Side Effects, and James A. Rowen Precision Radiotherapy Fund...111 (74%) received 30Gy; 95% cisplatin... These early data indicate that major de-escalation to 30Gy based on hypoxia status achieved significant toxicity reduction without compromise in survival for HPV+ OPC treated with chemoradiation without surgery."

Gastrointestinal Disorder • Head and Neck Cancer • Hematological Disorders • Neutropenia • Oncology • Oropharyngeal Cancer • Solid Tumor

Safety and Efficacy of Vocacapsaicin for Management of Postsurgical Pain: A Randomized Clinical Trial. (PubMed, Anesthesiology) - P2 | "A single, local administration of vocacapsaicin during surgery reduced pain and opioid consumption for at least 96 hours after surgery compared to control."

Clinical • Journal • Pain • TRPV1

Pilot Study Of Vocacapsaicin For Treatment Of Pain Following Open Laparotomy (ACS-CLINCON 2022) - P1/2 | "This pilot study suggests that a single intraoperative dose of vocacapsaicin provides clinically meaningful pain reduction for 96 hours following open laparotomy when added to a standard-of-care analgesic regimen. There were no safety concerns. The results are consistent with previous results in orthopedic surgery."

Clinical • Anesthesia • Gastroenterology • Orthopedics • Pain

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair (clinicaltrials.gov) - P1/2 | N=34 | Completed | Sponsor: Concentric Analgesics | Active, not recruiting ➔ Completed | N=150 ➔ 34 | Trial completion date: May 2022 ➔ Jun 2021 | Trial primary completion date: Apr 2022 ➔ Jun 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Pain

Pharmacokinetics and local tissue response to local instillation of vocacapsaicin, a novel capsaicin prodrug, in rat and rabbit osteotomy models. (PubMed, J Orthop Res) - "In rabbits, vocacapsaicin administered alone or in combination with ropivacaine did not adversely affect bone healing parameters. In conclusion, a single perioperative administration of vocacapsaicin in unilateral osteotomy models was well tolerated, locally and systemically, supporting its continued development as a novel, nonopioid treatment for postsurgical pain management."

Journal • PK/PD data • Preclinical • Orthopedics • Pain

Concentric Analgesics Announces Completion of $20 Million Financing and Appoints Two New Board Members as it Prepares to Initiate Registration-Enabling Phase 3 Studies for Vocacapsaicin (Yahoo News) - "Concentric Analgesics, Inc...today announced the closing of a $20 million convertible note financing from a combination of new and existing investors....Concentric intends to use the proceeds from the financing to further fund Phase 3 development activities for vocacapsaicin, its lead therapeutic candidate for postsurgical pain."

Financing • Pain

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 (Businesswire) - P2, N=147; NCT03599089; Sponsor: Concentric Analgesics; "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....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....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."

P2 data • CNS Disorders • Pain

Phase 1/2a trial of BMS-986148, an anti-mesothelin antibody-drug conjugate, alone or in combination with nivolumab in patients with advanced solid tumors. (PubMed, Clin Cancer Res) - P1/2 | "BMS-986148 {plus minus} nivolumab demonstrated a clinically manageable safety profile and preliminary evidence of clinical activity, supporting additional studies combining directed cytotoxic therapies with checkpoint inhibitors as potential multimodal therapeutic strategies in patients with advanced solid tumors."

Clinical • Combination therapy • Journal • P1/2 data • Oncology • Solid Tumor • MSLN

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair (clinicaltrials.gov) - P1/2; N=150; Active, not recruiting; Sponsor: Concentric Analgesics; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Pain

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Concentric Analgesics; Trial completion date: Jul 2021 ➔ May 2022; Trial primary completion date: Jun 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Gastroenterology • Pain

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Concentric Analgesics

Clinical • New P1/2 trial • Gastroenterology • Pain

Concentric Analgesics Announces Additional Positive Results from Phase 2 Clinical Trial of Vocacapsaicin (CA-008) in Total Knee Arthroplasty Surgery (Businesswire) - P1/2, N=193; NCT04203537; Sponsor: Concentric Analgesics; "Concentric Analgesics...today announced additional positive results from its recently completed Phase 2 clinical trial of vocacapsaicin (CA-008)...The 30% reduction in mean opioid consumption observed during hospitalization from 0-96h (p<0.0001) increased to a 52% reduction in opioid consumption after discharge from 96h-Day 15 (D15) (p=0.0063)...Based on the positive Phase 2 dose-ranging study results in two surgical models – TKA and bunionectomy...An End of Phase 2 Meeting with the FDA is scheduled in April 2021...the company will evaluate additional surgical models while finalizing plans for Phase 3."

FDA event • P1/2 data • CNS Disorders • Pain

Concentric Analgesics Announces Positive Topline Results from Phase 2 Clinical Trial of Vocacapsaicin (CA-008) in Total Knee Arthroplasty Surgery (Businesswire) - P1/2, N=193; NCT04203537; Sponsor: Concentric Analgesics; "Concentric Analgesics...today announced positive topline results from its recently completed Phase 2 clinical trial of vocacapsaicin (CA-008)...During the first 4 days (0-96 hours), vocacapsaicin reduced pain with activity, as measured by the pain intensity area under the curve (AUC), by 21% (p=0.0006) and pain at rest by 17% (p=0.0012)...For the period 0 – 168 hours, vocacapsaicin reduced pain with activity, as measured by the pain intensity AUC, by 17% (p=0.0072) and pain at rest by 15% (p=0.01) compared to the control group. During the first 7 days (0-168 hours), opioid consumption was reduced by 31% (p<0.0001) compared to the control group.."

P2 data • CNS Disorders • Pain

Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (clinicaltrials.gov) - P1/2; N=193; Completed; Sponsor: Concentric Analgesics; Recruiting ➔ Completed; N=300 ➔ 193

Clinical • Enrollment change • Trial completion • Pain

Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (clinicaltrials.gov) - P1/2; N=300; Recruiting; Sponsor: Concentric Analgesics; Trial completion date: Jul 2020 ➔ Oct 2020; Trial primary completion date: Jun 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date • Pain

Open-Label CA-008 in Bunionectomy (clinicaltrials.gov) - P2; N=36; Completed; Sponsor: Concentric Analgesics; Active, not recruiting ➔ Completed

Clinical • Trial completion