Vicromax (merimepodib) / BioSig Tech - LARVOL DELTA

Antiviral treatment of COVID-19: An update. (PubMed, Turk J Med Sci) - "The main drug groups include inhibitors of viral entry into the human cell (convalescent plasma, monoclonal antibodies, nanobodies, mini proteins, human soluble ACE-2, camostat, dutasteride, proxalutamide, bromhexin, hydroxychloroquine, umifenovir nitazoxanid, niclosamide, lactoferrin), inhibitors of viral proteases (lopinavir/ritonavir, PF-07321332, PF-07304814, GC376), inhibitors of viral RNA (remdesivir, favipiravir, molnupiravir, AT-527, merimepodib, PTC299); inhibitors of host proteins supporting virus (plitidepsin, fluvoxamine, ivermectin) and agents supporting host natural immunity (Interferons)...Additional studies are needed to define the role of remdesivir, favipiravir, interferons, ivermectin, dutasteride, proxulutamide, fluvoxamine, bromhexine, nitazoxanide and niclosamid in the treatment of COVID-19. Finally, the results of phase trials are waited to learn whether or not the newer agents such as molnupiravir, PF-07321332, PF-07304814, plitidepsin and AT-527..."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Targeting Some Enzymes with Repurposing Approved Pharmaceutical Drugs for Expeditious Antiviral Approaches Against Newer Strains of COVID-19. (PubMed, AAPS PharmSciTech) - "Recently, a combination of remdesivir, which has a competitively inhibitory effect on the nucleotide uptake in the virus, and the merimepodibs, an inhibitor of the enzyme inosine monophosphate dehydrogenase, which has a role in the synthesis of nucleotides of guanine bases, is in use in phase 2 clinical trials. However, new investigations suggest that using remdesivir, there is no statistically significant difference with uncertain clinical importance for moderate COVID-19 patients. Herein, an intellectual selection of approved drugs based on the safety profile is described, to target any essential enzymes that are required for the virus-receptor contact, fusion, and/or different stages of the life cycle of this virus, should help to screen drugs against newer strains of COVID-19.Graphical abstract."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

In silico studies of Potency and safety assessment of selected trial drugs for the treatment of COVID-19. (PubMed, In Silico Pharmacol) - "From the results, Merimepodib and Dexamethaxone demonstrated the most significant inhibitory potential against the PLpro. However, the only dexamethasone has attractive pharmacokinetic and toxicity properties probable for drug development; therefore, our study provides a basis for developing effective drugs targeting a specific protein in the SARS-CoV-2 life cycle. The online version contains supplementary material available at 10.1007/s40203-021-00105-x."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Mutational analysis in international isolates and drug repurposing against SARS-CoV-2 spike protein: molecular docking and simulation approach. (PubMed, Virusdisease) - "Further, we have analyzed the crystal structure of the 2019-nCoV chimeric receptor-binding complex with ACE2 (PDB ID: 6VW1) as a major target protein. The spike receptor binding protein (RBD) used as target region for our studies with FDA-approved drugs for repurposing, and identified few anti-SARS-CoV2 potential drugs (Silmitasertib, AC-55541, Merimepodib, XL413, AZ3451) based on their docking score and binding mode calculations expected to strongly bind to motifs of ACE2 receptor and may show impart relief in COVID-19 patients."

Biomarker • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 (clinicaltrials.gov) - P2; N=44; Terminated; Sponsor: ViralClear Pharmaceuticals, Inc.; N=80 ➔ 44; Active, not recruiting ➔ Terminated; Failure to meet primary endpoint

Clinical • Combination therapy • Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 (clinicaltrials.gov) - P2; N=80; Active, not recruiting; Sponsor: ViralClear Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

ViralClear halts its Phase 2 Hospitalized COVID-19 Trial (GlobeNewswire) - "BioSig Technologies, Inc....announced the halting of its signal finding Phase 2 trial....After the implementation of a protocol amendment that expanded the size of the trial from 40 to 80 hospitalized COVID-19 patients, and that limited enrollment to seriously ill patients...Safety Monitoring Committee (SMC) was unblinded for safety reasons....The unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib making it unlikely that the trial would meet its primary safety endpoints. The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered. At this time, the Company does not intend to further develop merimepodib."

Discontinued • Trial termination • Infectious Disease • Novel Coronavirus Disease

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: ViralClear Pharmaceuticals, Inc.; N=40 ➔ 80; Trial completion date: Aug 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Nov 2020

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

ViralClear Expands Ongoing Phase 2 Trial Size for its Oral Anti-Viral for the Treatment of COVID-19, Expands Trial Locations and Appoints Contract Manufacturing Organization to Manufacture Phase 3 Supplies of Merimepodib Oral Solution (GlobeNewswire) - P2, N=80; NCT04410354; Sponsor: ViralClear Pharmaceuticals, Inc.; "The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial...is being increased from 40 to 80 subjects....Based on a review of blinded data from the ongoing trial, subjects with scores of 3 and 4 are showing distinct differences. All subjects who were admitted with a score of 4 have had an uneventful course of disease and were rapidly discharged from the hospital due to improvement in clinical condition. The subjects who were admitted with a score of 3 fared differently....ViralClear has contracted with a US-based Contract Manufacturing Organization (CMO) to manufacture the registration stability batches....The merimepodib monotherapy trial to be conducted in the outpatient setting will be initiated after the completion of the current Phase 2 combination trial."

Clinical • Enrollment change • New trial • P2 data • Infectious Disease • Novel Coronavirus Disease

ViralClear to Host Conference Call on September 22, 2020, to Discuss Phase 2 Human Trial of AntiViral Merimepodib Oral Solution for Treatment of COVID-19 (GlobeNewswire) - "BioSig Technologies, Inc....subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that it will host a conference call to discuss its Phase 2 clinical trial. The study...evaluating the efficacy and safety of merimepodib (MMPD) in combination with remdesivir for hospitalized adult patients who have confirmed infection with SARS-CoV-2 and require non-invasive ventilation/high flow oxygen devices or supplemental oxygen....The trial is being conducted at 5 investigational sites across the United States (US)..."

Live event • Infectious Disease • Novel Coronavirus Disease

ViralClear Pharmaceuticals Partners With Albany Molecular Research Inc. (AMRI) on the Manufacture of Merimepodib Active Pharmaceutical Ingredient in Development for the Potential Treatment of COVID-19 (Businesswire) - "ViralClear Pharmaceuticals, Inc. (ViralClear), supported by Albany Molecular Research Inc., (AMRI)...is undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators....'AMRI is proud to partner with ViralClear in this vital effort of seeking a potential treatment for COVID-19,' said Christopher Conway, president, AMRI."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment of COVID-19 (GlobeNewswire) - "BioSig Technologies, Inc....today announced that it has commenced patient enrollment with the dosing of the first patient in its Phase II trial for merimepodib, a broad-spectrum, orally administered anti-viral drug candidate for the treatment of COVID-19 in adult patients. Confirmed trial sites include 3 sites from the Mayo Clinic..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: ViralClear Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Infectious Disease • Novel Coronavirus Disease

ViralClear Submits In Vitro Data on Merimepodib and Remdesivir Synergistic Activity Against the COVID-19 Novel Coronavirus to a Peer-Reviewed Journal (GlobeNewswire, BioSig Technologies, Inc.) - "BioSig Technologies, Inc....today announced that an article titled, 'The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro', was submitted to an online peer-reviewed life sciences journal....This article highlights pre-clinical data generated under contract with Galveston National Laboratory....Merimepodib...demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The molecule is currently undergoing extensive pre-clinical antiviral testing. Upon receipt of FDA permission of its IND, ViralClear intends to pursue development of this molecule for the treatment of COVID-19 through clinical trials in Q2 2020."

IND • Preclinical • Novel Coronavirus Disease

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: ViralClear Pharmaceuticals, Inc.

Clinical • Combination therapy • New P2 trial • Infectious Disease • Novel Coronavirus Disease

ViralClear to host conference call on June 9th to discuss upcoming and recent developments for phase II human clinical trials of its broad-spectrum oral anti-viral candidate for treatment of Covid-19 (GlobeNewswire) - "Company to provide updates on the initiation of human trials for treatment of adult hospitalized patients with COVID-19; Phase II clinical trial will be conducted with merimepodib and remdesivir in multiple sites nationwide with data expected in the third quarter 2020."

New P2 trial • P2 data • Infectious Disease • Novel Coronavirus Disease

ViralClear adds St. David's HealthCare in Austin, Texas, to its planned phase II trial for its broad-spectrum oral anti-viral candidate for Covid-19 (GlobeNewswire) - "BioSig Technologies, Inc....and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has expanded its patient enrollment centers....The Company intends to commence its Phase II clinical trial for merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients in the coming weeks."

Enrollment status • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced COVID-19, to Proceed (GlobeNewswire, BioSig Technologies, Inc.) - "Phase II clinical trial expected to be conducted at multiple centers in the United States, including three Mayo Clinic sites under the leadership of Andrew D. Badley, M.D., Enterprise Chair of COVID-19 Task Force....ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices....The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen."

IND • New P2 trial • Immunology • Novel Coronavirus Disease

ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib (GlobeNewswire, BioSig Technologies, Inc.) - "BioSig Technologies, Inc....and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced the closing of a $10.8 million common stock financing. ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum anti-viral agent. The financing was completed at a $100 million pre-money valuation."

Financing • Novel Coronavirus Disease

BioSig subsidiary ViralClear submits Investigational New Drug application to the FDA for phase II clinical trials for merimepodib, an orally administered treatment for patients with Covid-19 (GlobeNewswire) - "BioSig Technologies, Inc....today announced that its subsidiary ViralClear Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) for its Phase II clinical trial with Merimepodib as a treatment for COVID-19. The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in patients with COVID-19. The placebo-controlled Phase II clinical trial calls for 20 planned patients from three Mayo Clinic sites....Data from the Phase II trial is expected within three months of the commencement of the trial."

IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease

WHO officials indicating at least 20 vaccines in development in global race for a cure - "The World Health Organization is working with scientists across the globe on at least 20 different coronavirus vaccines with some already in clinical trials in record time - just 60 days after sequencing the gene, according to reports from CNBC. 'The acceleration of this process is really truly dramatic in terms of what we’re able to do, building on work that started with SARS, that started with MERS and now is being used for COVID-19,' Dr. Maria Van Kerkhove...said at a press conference at the organization’s headquarters in Geneva, recently."

Media quote

Mayo Clinic preparing to Commence Phase II FDA clinical trial for the treatment of COVID-19 with Vicromax (GlobeNewswire, BioSig Technologies, Inc.) - "IND filing with FDA expected in coming weeks with study initiation targeted for May 2020....Recently published in-vitro data demonstrated that Vicromax™ decreased viral production of SARS-CoV-2 by over 98%....BioSig Technologies, Inc....today announced that its subsidiary ViralClear Pharmaceuticals, Inc. updated its clinical development program for Vicromax™ (merimepodib, or MMPD) as a treatment for COVID-19. Under the terms of a new agreement, the Phase II clinical trial will be conducted at Mayo Clinic....The study will be a randomized, placebo-controlled trial. Data from the Phase II trial is expected within three months."

IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease

BioSig subsidiary NeuroClear acquires license for a broad-spectrum anti-viral agent that may treat Covid-19. Laboratory results demonstrate high level of activity against Covid-19 in cell culture (GlobeNewswire) - "BioSig Technologies, Inc...acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19)....Anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing....The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials....The Company intends to develop Vicromax(tm) and take it through clinical trials under a new NeuroClear subsidiary, ViralClear Pharmaceuticals, Inc."

New trial