COVID-19 Top News – June 29, 2020

June 29, 2020

stannous protoporphyrin (RBT-9) / Renibus Therap
Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) – Jun 23, 2020 – “Renibus Therapeutics, Inc….announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19….RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.”


losmapimod (FTX-1821) / Fulcrum Therap
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients (GlobeNewswire) – Jun 24, 2020 – “Fulcrum Therapeutics, Inc….today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod…..LOSVID trial is…in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness….An interim analysis will be conducted in the fourth quarter of 2020 for futility and sample size re-estimation….Topline data is expected to be reported in the first quarter of 2021.”


hydroxychloroquine / Generic mfg.
It’s the end of road for hydroxychloroquine in COVID-19 as Novartis, NIH and WHO pull out of trials (Fierce Pharma) – Jun 22, 2020 – P=NA, N=470; “…the World Health Organization (WHO), generic hydroxychloroquine (HCQ) maker Novartis and the U.S. National Institutes of Health (NIH) have all ended their HCQ COVID-19 studies….Sanofi previously put a temporary halt to its own study based on safety….Novartis said it would discontinue its sponsored HCQ trial for COVID-19….NIH also decided that its Orchid study of HCQ would no longer continue after a fourth interim analysis by an independent data monitoring panel found the drug provided no additional benefit over placebo control.”


EDP1815 / Evelo Biosci
Evelo Biosciences Announces EDP1815 to Advance into Phase 2/3 TACTIC-E COVID-19 Trial (GlobeNewswire) – Jun 22, 2020 – “Evelo Biosciences, Inc….announced today that EDP1815 will be included in the TACTIC-E clinical trial. The trial will evaluate the safety and efficacy of certain experimental therapies….Interim data from the trial are anticipated during the fourth quarter of 2020. If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.”


aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19 (GlobeNewswire) – Jun 24, 2020 – “NeuroRx, Inc….today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19….As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy…”


EMD Serono Initiates First Clinical Trial of TLR7 and 8 Inhibitor as a Potential Treatment for Severe Symptoms of Covid-19 Infection (EMD Serono Press Release) – Jun 25, 2020 – “EMD Serono…today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. The Company will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population….M5049 will be investigated in a randomized, placebo-controlled study at sites in the United States and Brazil….In addition to the FDA, Merck KGaA, Darmstadt, Germany is working with other global health authorities and investigators to accelerate clinical development to meet the critical need presented by the current global pandemic and expects results from the Phase II study around the end of 2020.”


Celltex-AdMSCs / Celltex
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19 (Businesswire) – Jun 26, 2020 – “Celltex…today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).”


VP01 / Vicore Pharma
Battling the cytokine storm (PharmaTimes) – Jun 25, 2020 – “Researchers have recently identified part of the cytokine storm known as a ‘burning point’….The research shows that this occurs five days before what the authors describe as a ‘composite end point event’ or CEPE….Another marker identified by researchers is a deficiency of vitamin D….At Vicore we have been researching the RAS for nearly 20 years….We are trialling VP01, (sic) an experimental first in class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, as a potential COVID-19 treatment.”


remdesivir / Generic mfg.
Gilead to Test Inhaled Form of Remdesivir in COVID-19 Starting in August (BioSpace) – Jun 22, 2020 – “‘From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of COVID-19, in parallel with emerging knowledge about the disease,’ said Merdad Parsey…’While the novel coronavirus appears to disproportionally affect adults-especially the elderly and those with underlying health conditions-concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms.'”


Hopeful for a COVID-19 vaccine by late 2020, early 2021: Dr Anthony Fauci (Financialexpress) – Jun 23, 2020 – “The government’s top infectious disease expert said Tuesday he is cautiously optimistic that there will be a COVID-19 vaccine by the end of the year or early 2021, but warned that the next few weeks will be critical to tamping down coronavirus hot spots around the country….’We will be doing more testing,’ Fauci told a House committee.”

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