Unafra (opiranserin) / Vivozon - LARVOL DELTA

Discovery of a Novel Multitarget Analgesic Through an In Vivo-Guided Approach. (PubMed, Pharmaceuticals (Basel)) - "Compound 29, derived from a novel scaffold inspired by opiranserin and vilazodone pharmacophores, was identified through analog screening in the formalin test. Compound 29 is a promising multitarget analgesic with potent efficacy and favorable pharmacokinetics. Ongoing optimization efforts aim to mitigate side effects and enhance its therapeutic profile for clinical application."

Journal • Preclinical • Neuralgia • Pain

Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. (PubMed, J Clin Anesth) - P3 | "When compared to placebo, VVZ-149 infusion demonstrated a significant reduction of pain within the first 12 h after surgery with a substantial decrease in opioid use. VVZ-149 rapidly lowers the pain intensity starting at as early as 4 h post-dose, allowing subjects to experience mild pain levels from 8 h through 48 h. Therefore, the analgesic effect of VVZ-149 was shown to effectively relieve pain and reduce opioid use for treating moderate to severe pain in the early postoperative care setting."

Journal • P3 data • Anesthesia • Pain

Phase 3 Efficacy and Safety of VVZ-149 Injections for Postoperative Pain Following Laparoscopic Colectomy (clinicaltrials.gov) - P3 | N=285 | Completed | Sponsor: Vivozon Pharmaceutical Inc.

New P3 trial • Pain

Exploratory study of VVZ-149, a novel analgesic molecule, in the affective component of acute postoperative pain after laparoscopic colorectal surgery. (PubMed, J Clin Anesth) - P2 | "VVZ-149 resulted in a non-significant reduction of postoperative pain during the first 8 h after surgery. Post hoc analysis indicates that VVZ-149 may benefit patients with negative affect who otherwise have higher postoperative opioid use. REGISTRATION NUMBER: www.clinicaltrials.gov, ID: NCT02489526."

Journal • Anesthesia • CNS Disorders • Depression • Pain • Psychiatry

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Infectious Disease • Novel Coronavirus Disease

Role of VVZ-149, a Novel Analgesic Molecule, in the Affective Component of Pain: Results from an Exploratory Proof-of-Concept Study of Postoperative Pain following Laparoscopic and Robotic-Laparoscopic Gastrectomy. (PubMed, Pain Med) - P2 | "VVZ-149 demonstrated effective analgesia with reduced postoperative pain and opioid requirements. Consistent with the results from the previous Phase 2 study, patients with early rescue requirement had greater benefit from VVZ-149, supporting the hypothesis that VVZ-149 may alleviate the affective component of pain and mitigate excessive use of opioids postoperatively."

Journal • Pain

Non-preserved "Opiranserin Phase 2b Research Result in International Journal" (docdocdoc.co.kr) - P2b, N=60; NCT03997812; Sponsor: Vivozon, Inc.; "Non-Preservation announced on the 15th that the results of a proof-of-concept (PoC) study of the non-narcotic analgesic drug 'opiranserin (VVZ-149)' that it is developing will be published in the international journal Pain Medicine...research team confirmed the analgesic effect of opiranserin in phase 2b, the reduction of narcotic analgesics, and excellent safety and tolerability."

P2b data • CNS Disorders • Pain

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Clinical

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‘Vivozon’s Inist Bio takeover boosts nonnarcotic painkiller trial’ (Korea Biomedical Review) - Lumimicro, an affiliated company with Vivozon, said it would acquire Inist Bio Pharmaceutical and change its company name to Vivozon Healthcare. The acquisition is likely to give Vivizon and Lumimicro the capacity to manufacture the key pipeline, opiranserin (VVZ-149) directly, observers said....Shares of Lumimicro surged 29.87 percent on Wednesday from the previous day and closed at 2,435 won per share. However, on Thursday, the stock price plummeted 27.52 percent to as low as 1,885 won, reflecting investors’ worries over the acquisition plan."

M&A • Stock price • CNS Disorders • Pain

[SEN] Lumi Micro acquires Inist Bio Pharmaceuticals… Securing a production base for 'Opiranserin [Google translation] (Sedaily) - "Non-preservation of a new drug development bio company specializing in pain and central nervous system disease on the 23rd Lumi Micro (082800) It announced that it has acquired Inist Bio Pharmaceuticals....'Through this acquisition of Inist Bio Pharmaceuticals, Non-Conservation and Lumi Micro will lay the foundation for a global comprehensive pharmaceutical group that can range from new drug development to finished drug production and sales. It is expected to accelerate the progress of phase 3 clinical trials in Korea for the non-conservative, innovative new drug Offirangerin (VVZ-149).'"

M&A • Pain

Non-preservation, transfer agreement of Opirangerine injection license to subsidiary Lumi Micro [Google translation] (Maekyung Media Group) - "Bibozon...announced on the 3rd that it has signed an exclusive license agreement in Korea for the non-narcotic anti-drug drug Opirangerine injection with Lumi Micro....With the signing of this license agreement, Bi-Preservation and Lumi Micro plan to quickly promote phase 3 clinical trials in Korea. In addition, non-preservation plans to promote the exclusive production of domestic drug substance and finished drug product of Opirangerine through Lumi Micro, and ultimately secure supply rights to the world."

Licensing / partnership • CNS Disorders • Pain

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Covid-19 makes Vivozon halt P3 trial of nonnarcotic analgesics in US (Korea Biomedical Review) - "...It has halted its phase 3b clinical trials for using opiranserin, its non-narcotic analgesics, in treating bunionectomy due to difficulties in recruiting patients during the Covid-19 outbreak in the U.S."

Trial suspension • Pain

Building an organisational resilience maturity framework. (PubMed, J Bus Contin Emer Plan) - "Organisations with a higher level of internal resilience are better poised to mobilise resources, allocate personnel and prioritise key functions, with leadership teams unafraid to make difficult decisions based on intelligence and evidence-based analysis, although there is still a limited understanding of how a resilience framework can benefit the bottom line. Effective leadership, evidence-based decision-making and business intelligence collection and dissemination are critical to success; however, to truly build resilience capability, organisations need to develop a learning organisation mentality, and move the concept of organisational resilience away from technology to become a people-focused strategy. Organisations must change the mentality of using resilience to generate short-term financial gains and instead focus on long-term sustainability."

Journal

Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: Vivozon, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Pain

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CNS Disorders • Migraine

Vivozon to start P3b trial of nonnarcotic analgesics in US (Korea Biomedical Review) - "Vivozon said that it has started recruiting patients for phase 3b clinical trial of Opiranserin, its non-narcotic analgesics for treating patients who had undergone a bunionectomy. The trial aims to register 300 patients by the end of October and publish top-line results in December this year or January next year. Depending on the outcome of the trial, the company will decide on conducting additional clinical phase 3 and open-label safety studies in the future....'Considering that a second viral wave may hit the country, we will complete registration in three to four months...'"

Enrollment open • P3 data: top line • CNS Disorders • Pain

[Features] Telcon RF Pharmaceuticals Announces Strong Announcement of Phase 3b of Non-preserved Opiranserine [Google translation] (Maekyung Media Group) - "Telcon RF Pharmaceuticals, the largest shareholder, is rising on the news that clinical trial phase 3b patient registration for Opiranzerin (VVZ-149), which is being developed by a non-conservative drug development company, is going to take place in July."

Trial status • Pain

Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: Vivozon, Inc.

Clinical • New P3 trial • Pain

Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Vivozon, Inc.

Clinical • New P1 trial

Non-preservation ‘Full-scale pharmaceutical and bio business with Lumimicro’ [Google translation] (Maekyung Media Group) - "Non-preservation...announced on the 12th that it is going to enter the pharmaceutical business with Lumimicro in order to leap into a global healthcare company....Non-preservation is planning to conduct clinical trial phase 3 of the non-drug analgesic drug 'Opiranserine (VVZ-149)' in Korea and China through the new Lumimicro Pharmaceutical Division."

Licensing / partnership • New P3 trial • CNS Disorders • Pain