COVID-19 Top News – May 18, 2020

May 18, 2020

VPM1002 / Max Planck Institute, SAKK, Serum Institute of India
A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals’ Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System ( – May 13, 2020 – P3; N=1200; Not yet recruiting; Sponsor: Vakzine Projekt Management GmbH


aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics announces filing of IND for phase 2/3 clinical trial of inhaled RLF-100 targeting early Covid-19 lung injury (GlobeNewswire) – May 11, 2020 – “RELIEF THERAPEUTICS Holding AG…announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol…to conduct a Phase 2/3 clinical trial assessing inhaled RLF-100 as a treatment for patients with non-acute lung injury caused by the SARS-CoV-2 virus….The multicenter randomized placebo-controlled trial aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms….The trial will be conducted in at least 20 sites. Patients will be randomized to receive inhaled RLF-100 plus standard of care or placebo plus standard of care. The primary endpoints will be progression to ARDS…”


Ampligen (rintatolimod) / AIM ImmunoTech
AIM Immunotech announces FDA authorization for first human Ampligen trial in Covid-19 patients with cancer; provides corporate business update for the first quarter of 2020 (Yahoo Finance) – May 14, 2020 – “AIM ImmunoTech…announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company’s lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus….The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski….The phase 1/2b study will enroll approximately 40 patients in two stages.”


Veklury (remdesivir) / Gilead
EMA recommends expanding compassionate use of Gilead’s Covid-19 drug (TODAYonline) – May 12, 2020 – “The European Medicines Agency (EMA)…recommended that the compassionate use of Gilead Sciences Inc’s…experimental drug remdesivir be expanded so that more patients with severe COVID-19 can be treated….The agency, which last month started a rolling review of data on the use of remdesivir for COVID-19 treatment, said it also introduced a five-day course of the drug, alongside the longer 10-day course, for patients not requiring assisted ventilation.”


mosedipimod (EC-18) / Enzychem Lifesciences
Enzychem Lifesciences to start P2 trial of Covid-19 treatment (Korea Biomedical Review) – May 13, 2020 – “Enzychem Lifesciences said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct phase 2 clinical trials of EC-18, a treatment candidate for Covid-19….Enzychem plans to speed up efforts to make a similar application to the U.S. Food and Drug Administration. The company will begin clinical trials to demonstrate the efficacy of EC-18 with several clinical institutions, including Chungbuk National University Hospital. The trial on 60 patients will be a double-blinded placebo-controlled trial to increase the value of efficacy data.”


mRNA-1273 / Moderna Therapeutics
Moderna receives FDA Fast Track designation for mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – May 12, 2020 – “Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020….Moderna, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2)….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.”


VERU-111 / Veru Inc
Veru Secures FDA Agreement to Initiate Phase 2 Study of VERU-111, Novel Microtubule Depolymerization Drug to Combat COVID-19 (GlobeNewswire, Veru Healthcare) – May 12, 2020 – “Veru Inc….today announced that it has received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111, a microtubule depolymerization agent, in combating COVID-19….The Company met with FDA and received agreement on the clinical development program for VERU-111 as a potential dual antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program….The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients….The primary efficacy endpoint will be the proportion of patients that are alive and without respiratory failure at Day 29….The study is expected to commence in the next 2 weeks.”


Cuba works on new product to fight “Cytokine Storm” produced by Covid-19 (Escambray) – May 14, 2020 – “The Center of Molecular Immunology (CIM by its Spanish acronym) is working to obtain an antagonist of interleukin-6, a product that can be used to inhibit the so-called ‘cytokine storm’….The project is in its initial phase….Three of the drugs that make up the Cuban protocol for the treatment of COVID-19 are developed by the Center for Molecular Immunology: the monoclonal antibody Itolizumab, created to combat leukemias and lymphomas; the recombinant human erythropoietin, of proven efficacy in people with renal failure and, finally, the stem cell generating factor LeukoCIM.”


FDA approves Covid-19 trial after successful emergency use of umbilical stem cells from RESTEM (PRNewswire) – May 14, 2020 – “RESTEM…announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S….The randomized, placebo-controlled and blinded study will look at whether this may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19….The study is expected to start enrolling patients from Baptist Health South Florida and Sanford Health this week….Sanford Health will also be a key strategic partner for this study.”


Dr. Anthony Fauci says there’s ’virtually no chance’ that COVID-19 will be eradicated (Business Insider) – May 12, 2020 – “Dr. Anthony Fauci said that there’s little chance that the novel coronavirus, which causes the disease COVID-19, will be completely eradicated in an interview with NBC Sports….’It is so transmissible, and it is so widespread throughout the world, that even if our infections get well-controlled and go down dramatically during the summer, there is virtually no chance it will be eradicated,’ Fauci said of the novel coronavirus.”

No Comments

Post a Comment