Discover
lenzilumab (KB003) / HumanigenPhase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Apr 17, 2020 - P3; N=238; Not yet recruiting; Sponsor: Humanigen, Inc.Farxiga (dapagliflozin) / Ono Pharma, AstraZenecaDARE-19: Dapagliflozin in Respiratory Failure in Patients With COVID-19 (clinicaltrials.gov) - Apr 17, 2020 - P3; N=900; Recruiting; Sponsor: Saint Luke's Health SystemUniversity of Waterloo to develop nasal vaccine for Covid-19 (Pharmaceutical-technology.com) - Apr 17, 2020 - "University of Waterloo researchers in Canada are developing a DNA-based vaccine candidate that can be given via nasal route to protect from Covid-19 infection. The vaccine will use bacteriophage-based approach...formulated to act on tissues in the nasal cavity and lower respiratory tract....A team led by Ho is designing the nanomedication, delivered by the nasal spray....Aucoin’s lab is constructing and purifying the VLP and working to enhance immunity after the initial administration of the vaccine. Slavcev’s research team...is now altering the system for Covid-19 application....A Natural Sciences and Engineering Research Council of Canada grant are supporting the research components."Vicromax (merimepodib) / BioSig TechMayo Clinic preparing to Commence Phase II FDA clinical trial for the treatment of COVID-19 with Vicromax (GlobeNewswire, BioSig Technologies, Inc.) - Apr 16, 2020 - "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."Yeliva (opaganib) / RedHillIND for Covid-19 with opaganib submitted to the FDA by RedHill Biopharma (GlobeNewswire) - Apr 17, 2020 - "RedHill Biopharma Ltd....today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640)1, for the treatment of SARS-CoV-2 infection (COVID-19). The IND submission follows preliminary discussions with the FDA on the study design. The proposed randomized, double-blind, placebo-controlled Phase 2a study is intended to evaluate the safety and efficacy of opaganib in up to 60 adult patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S."COV-ENT-1 / EnterinEnterin to conduct a randomized phase 1/2a study in hospitalized patients with Covid-19 (PRNewswire) - Apr 17, 2020 - "Enterin, Inc....announced today that it has received feedback from the FDA laying out the path for a Phase 1/2a study in hospitalized patients with COVID-19 infection. The study will involve 10 U.S. sites and will enroll 80 hospitalized patients. Patients will have been diagnosed with SARS-CoV-2, have an SpO2 ≤94% or evidence of pneumonia by chest XR or CT scan. The first stage will involve 24 patients....The second stage will involve another 56 patients....The compound is administered by inhalation via standard nebulizer....Assuming Enterin is allowed to proceed with the study, it is anticipated that the study will begin within the next three months."mRNA-1273 / Moderna TherapeuticsModerna announces award from U.S. government agency BARDA for up to $483 million to accelerate development of mRNA vaccine (mRNA-1273) against novel coronavirus (PipelineReview) - Apr 17, 2020 - "Moderna, Inc....today announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA)...The Phase 1 open-label study...has completed enrollment of the original study....The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing....Company intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as soon as fall, 2020."Roche develops new serology test to detect Covid-19 antibodies (Roche Press Release) - Apr 17, 2020 - "Roche...today announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease....Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible."ThermoGenesis receives acknowledgement letter from FDA allowing its SARS-CoV-2 (Covid-19) IgM/IgG antibody fast detection kit for distribution (PRNewswire) - Apr 16, 2020 - "ThermoGenesis Holdings, Inc....announced today that...following submission of notification to the U.S. Food and Drug Administration (FDA), the Company has received the necessary acknowledgement letter which provided confirmation that the ThermoGenesis' SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated....The required registrations and listings with FDA have been completed, which now allow the diagnostic kit to be distributed."INO-4800 / InovioIVI, INOVIO, and KNIH to partner with CEPI in a phase I/II clinical trial of INOVIO’s COVID-19 DNA vaccine in South Korea (International Vaccine Institute) - Apr 16, 2020 - "The International Vaccine (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO (NASDAQ:INO) to work with IVI and the Korea National Institute of Health (KNIH) for Phase I/II clinical trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea....Dr. Richard Hatchett...said, 'Developing a safe and effective vaccine and ensuring its global supply is our best exit strategy from the COVID-19 pandemic. CEPI is pleased to work with Inovio and IVI in this critical next stage of testing.'"
