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BNT162 / Pfizer, BioNTechBioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates (GlobeNewswire, BioNTech SE) - Apr 22, 2020 - "BioNTech SE...and Pfizer Inc....have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection....The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly....The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects...aiming to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA."Stalaris (ATYR1923) / aTyr Pharma, KyorinaTyr Pharma Announces Phase 2 Study of ATYR1923 in COVID-19 Patients with Severe Respiratory Complications Following FDA Acceptance of IND Application (GlobeNewswire, aTyr Pharma, Inc.) - Apr 21, 2020 - "aTyr Pharma, Inc...today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its lead therapeutic candidate, ATYR1923, in a Phase 2 study in COVID-19 patients with severe respiratory complications. The Phase 2 clinical trial will be a randomized, double blind, placebo-controlled study with ATYR1923 in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States. Patients enrolled in the trial will be assigned to one of three cohorts of 10 patients each. Patients will receive a single intravenous (IV) dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo."ReiThera, Leukocare and Univercells announce Pan-European Consortium for the fast-track development of a single-dose adenovirus-based Covid-19 vaccine (PRNewswire) - Apr 23, 2020 - "Italian ReiThera Srl. (Rome), German LEUKOCARE AG (Munich), and Belgian Univercells S.A. (Brussels), today announced a strategic collaboration for the development and large-scale manufacturing of a novel adenoviral vector-based vaccine against COVID-19....ReiThera is currently preparing for a COVID-19 first-in-human trial to be started in Italy in summer 2020....LEUKOCARE contributes to the drug product development by developing a highly stable liquid vaccine formulation based on its well-established technology platform for formulations of viruses and viral vectors."Xpovio (selinexor) / Ono Pharma, Karyopharm, AntengeneKaryopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19 (GlobeNewswire, Karyopharm Therapeutics Inc.) - Apr 20, 2020 - "Karyopharm Therapeutics Inc....today announced dosing of the first patient in a randomized Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. This global study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel. Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1 which is involved in both the replication of SARS-CoV-2, the virus that causes COVID-19, and in the inflammatory response to the virus."Ultomiris IV (ravulizumab IV) / Alexion PharmaAlexion announces plans to initiate phase 3 Study of Ultomiris(ravulizumab-cwvz) in hospitalized patients with severe Covid-19 (Businesswire) - Apr 20, 2020 - "Alexion Pharmaceuticals, Inc....today announced plans to initiate a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19....The study is expected to enroll approximately 270 patients across countries with high numbers of diagnosed cases, beginning in May, and will evaluate the impact of ULTOMIRIS....This follows the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Alexion’s investigational new drug (IND) application for ULTOMIRIS for severe COVID-19."Farxiga (dapagliflozin) / Ono Pharma, AstraZenecaAstraZeneca and Saint Luke’s Mid America Heart Institute initiate phase III DARE-19 trial with Farxiga in Covid-19 patients (AstraZeneca Press Release) - Apr 23, 2020 - "AstraZeneca and Saint Luke’s Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. The goal of the trial, called DARE-19, is to assess whether Farxiga...in patients who also have cardiovascular (CV), metabolic or kidney risk factors....The DARE-19 trial is open for enrolment in the US and other European countries with a high COVID-19 burden and aims to recruit approximately 900 patients."Oxford University coronavirus vaccine to begin human trials on Thursday as U.K. throws everything at vital breakthrough (Market Watch) - Apr 22, 2020 - "A coronavirus vaccine being developed by Oxford University will enter human trials as early as this Thursday, according to the U.K.’s health secretary. The U.K. government will provide £20 million ($24 million) to the university’s team and a further £22.5 million to Imperial College, where scientists are also working on a vaccine. Scientists at Oxford have previously said the aim is to produce a million doses of the vaccine by September."AT-H201 / Atossa TherapAtossa Therapeutics Seeks Clinical Investigation Approval from FDA to Launch the COVID-19 HOPE Study (GlobeNewswire, Atossa Therapeutics, Inc.) - Apr 20, 2020 - "Atossa Therapeutics, Inc....has applied to the FDA for approval to commence a clinical study of its proprietary drug, AT-H201, in COVID-19 patients on mechanical ventilation....The goal of the clinical trial, called the HOPE Study, is to demonstrate improved lung function and reduce the amount of time that COVID-19 patients are on ventilators....'This is the first trial that I am aware of that is testing nebulized pharmaceuticals for patients on mechanical ventilation. Atossa looks forward to working on this important medical need and to reduce the death toll of COVID-19.'"chloroquine phosphate / Generic mfg.; hydroxychloroquine / Generic mfg.; azithromycin / Generic mfg.NIH panel recommends against drug combination promoted by Trump for COVID-19 (NPR) - Apr 21, 2020 - "'The combination of hydroxychloroquine and azithromycin was associated with QTc prolongation in patients with COVID-19,' the panel said....As for using the use of hydroxychloroquine or chloroquine alone, the panel said there was 'insufficient clinical data to recommend either for or against.' It reached the same conclusion about the drug remdesivir. The expert panel, convened by the NIH Institute that Dr. Anthony Fauci directs, produced a set of guidelines for doctors to use in treating COVID-19 patients. The panelists come from a variety of health care disciplines. For the most part, the guidelines are agnostic about the use of experimental medications, pointing out that strong scientific evidence is lacking to make a firm conclusion one way or the other."hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.New U.S. treatment guidelines for Covid-19 don’t see much progress (The New York Times) - Apr 21, 2020 - "The federal agency led by Dr. Anthony Fauci issued guidelines on Tuesday that stated there is no proven drug for treating coronavirus patients...Months into the pandemic, a panel of experts convened by the research center Dr. Fauci leads, the National Institute of Allergy and Infectious Diseases, concluded that whenever possible, drug therapy should be given as part of a clinical trial, so that data can be collected to determine whether treatments work....Dr. Fauci has repeatedly pushed back at the president’s enthusiasm over the malaria drugs hydroxychloroquine and chloroquine, sometimes disagreeing in public with Mr. Trump."
