COVID-19 Top News – June 1, 2020

dendrimer N-acetyl-cysteine (OP-101) / Ashvattha TherapAshvattha Therapeutics subsidiary Orpheris announces FDA agreement to initiate phase 2 study evaluating OP-101 in severe Covid-19 patients (Businesswire) - May 28, 2020 - "Orpheris...today announced the U.S. Food and Drug Administration (FDA) has agreed to a Phase 2 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OP-101 in patients with severe COVID-19....The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled evaluation....An evaluation of reduction in pro-inflammatory markers (CRP, ferritin, and IL-6) after treatment with OP-101 is also included in the study....A single IV dose Phase 1 study of OP-101 (20 or 40 mg/kg) in normal healthy volunteers demonstrated that OP-101 is generally well tolerated in healthy subjects..."APL-9 / ApellisApellis Initiates Phase 1/2 Study of APL-9 in Patients with Severe COVID-19 (GlobeNewswire, Apellis Pharmaceuticals, Inc.) - May 28, 2020 - "Apellis Pharmaceuticals....today announced that the company has initiated a Phase 1/2 clinical study of APL-9...in COVID-19 patients with respiratory failure including acute respiratory distress syndrome (ARDS)....Apellis initiated the Phase 1/2 study following preliminary results from its ongoing, non-interventional study in patients with ARDS secondary to COVID-19, which showed a substantial increase in the activation of the complement cascade....Apellis initiated the study upon clearance by the U.S. Food and Drug Administration, which expedited the review of the investigational new drug application for APL-9 in COVID-19."CERC-002 / Kyowa Hakko Kirin, Sanofi, CerecorCerecor and Myriad Genetics Announce that Levels of LIGHT, a Novel Cytokine, Were Highly Correlated with Disease Severity and Mortality in COVID-19 ARDS Biomarker Study (GlobeNewswire, Cerecor Inc.) - May 26, 2020 - P=NA, N=77; "Cerecor Inc....and Myriad Genetics Inc....today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network....LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls (p value < 0.0001). The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02)."interferon beta inhalation (SNG001) / SynairgenSynairgen Completes Recruitment of Hospitalised Patients in COVID-19 Trial (GlobeNewswire, Synairgen plc) - May 28, 2020 - "Synairgen plc...is pleased to announce that recruitment of 100 hospitalised patients in its clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients has now been completed....A successful outcome will inform onwards progression of SNG001 in COVID-19 patients. Results from the hospital setting are expected in July 2020..."stannous protoporphyrin (RBT-9) / Renibus TherapDatatrak International, Inc. Partners with Renibus Therapeutics, Inc. for Upcoming COVID-19 Clinical Trial (GlobeNewswire, Datatrak International) - May 26, 2020 - "Datatrak International, Inc....announces a new partnership with Renibus Therapeutics, Inc. for their COVID-19 clinical trial....Renibus has been fast tracked by the FDA to begin a Phase 2 study to evaluate the effects of their drug, RBT-9 in COVID-19 patients who are at high-risk of deteriorating health due to age or comorbid conditions such as kidney or cardiovascular disease."TJM2 / I-MabI-Mab reports interim results from part 1 study for anti-GM-CSF antibody TJM2 to treat Covid-19 patients with -cytokine release syndrome (PRNewswire) - May 27, 2020 - P1/2, N=114; NCT04341116; Sponsor: I-Mab Biopharma; "I-Mab...today announced interim results....Part 1 of the study evaluated the safety and tolerability of TJM2 in a total of 24 patients...After comprehensive review and analysis, the DMC concluded that I-Mab can commence the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in the severe COVID-19 patients in the study. The DMC also endorsed protocol changes....Part 2 of the study with a similar design to Part 1 will target the same patient population and is expected to be initiated shortly."ifenprodil (NP-120) / Algernon PharmaAlgernon Submits Investigational New Drug (IND) Application with U.S. FDA for Multinational Phase 2b/3 Human Study to Evaluate Ifenprodil for COVID-19 (GlobeNewswire, Algernon Pharmaceuticals) - May 25, 2020 - "Algernon Pharmaceuticals Inc....is pleased to announce that it has submitted an Investigational New Drug (IND) application with the U.S. FDA for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19....Once local ethics approvals have been received, the trial will begin as a Phase 2b study of an aggregate of 100 patients and with positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial."favipiravir / Generic mfg.; Arbidol (umifenovir) / PharmstandardGlenmark to commence new phase 3 clinical trial on combination of two anti-viral drugs favipiravir and umifenovir in hospitalized patients of moderate Covid-19 in India (PRNewswire) - May 26, 2020 - "Glenmark received approval from Indian regulator to initiate study....Glenmark Pharmaceuticals...announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir....The new combination clinical trial will be called FAITH....158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care....Simultaneously Glenmark is conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients..."Actemra IV (tocilizumab) / Roche, JW Pharma; Veklury (remdesivir) / GileadGenentech initiates phase III clinical trial of Actemra plus remdesivir in hospitalized patients with severe Covid-19 pneumonia (Businesswire) - May 28, 2020 - "Genentech...today announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra® (tocilizumab) plus the investigational antiviral remdesivir....The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the United States, Canada and Europe....Genentech is close to completing enrollment of the global randomized, double-blind, placebo-controlled Phase III clinical trial....Data from the REMDACTA trial are designed to supplement the COVACTA study."Fauci: ‘We Might Have A Vaccine By The End Of The Year’ (Forbes) - May 27, 2020 - "'We have a good chance-if all the things fall in the right place-that we might have a vaccine that would be deployable by the end of the year, by November-December,' Dr. Fauci said on CNN Wednesday morning. Fauci explained that the vaccine trials with Niaid are proceeding 'at risk,' meaning researchers are taking 'the next steps before the results of the previous step,' which can shorten the development process by months."