Discover
BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTechPFIZER AND BIONTECH GRANTED FDA FAST TRACK DESIGNATION FOR TWO INVESTIGATIONAL MRNA-BASED VACCINE CANDIDATES AGAINST SARS-COV-2 (Pfizer Press Release) - Jul 13, 2020 - "Pfizer Inc. (NYSE: PFE) and BioNTech...today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program...received Fast Track designation from the U.S. Food and Drug Administration (FDA)....The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities....Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects....Companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021."BNT162b1 / Fosun Pharma, BioNTech, PfizerFosun Pharma Announces its Licensed COVID-19 Vaccine Product Receives Acceptance Notice of Clinical Trial Application by NMPA (PRNewswire) - Jul 14, 2020 - "...Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ('Fosun Pharmaceutical Industrial') has received the acceptance notice of clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 (the 'Vaccine'). The clinical trial application of the Vaccine was accepted by the National Medical Products Administration (the 'NMPA')....'We hope that the clinical trial will be initiated in China as soon as possible, and the global pandemic will be defeated eventually with the launch of a safe and effective vaccine.'"mosedipimod (EC-18) / Enzychem LifesciEnzychem Lifesciences Files IND Application to FDA for Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia (PRNewswire) - Jul 13, 2020 - "Enzychem Lifesciences...today announced that it has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18....A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea....The study duration is 12 months from the FDA approval date. The study plans to enroll a total of 60 subjects in total, 30 patients in the EC-18 arm and the other 30 patients on the placebo arm....'We are preparing plans for initiating the Phase 2 study upon the IND becoming active by the U.S. FDA...'"Yeliva (opaganib) / RedHillRedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia (GlobeNewswire) - Jul 16, 2020 - P=Obs, N=23; NCT04435106; "The Phase 2/3 study aims to enroll 270 subjects in up to 40 clinical sites; enrollment planned to be initiated later this month with potential submission of Emergency Use Authorization application planned for Q4/2020; In parallel, the U.S. Phase 2a study with opaganib in patients with severe COVID-19 is advancing rapidly with more than 25% of patients enrolled; Approval also received for a clinical study with opaganib in Israel in up to 50 patients with severe COVID-19; Treatment of patients with severe COVID-19 under compassionate use showed substantial benefit to such patients compared to a matched case-control group; RedHill Biopharma Ltd....today announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib..."brilacidin (PMX-30063) / Innovation PharmaInnovation Pharmaceuticals – Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted to Commence Q4 2020 (GlobeNewswire) - Jul 13, 2020 - "Innovation Pharmaceuticals...today provides perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties...have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020....Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19....Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020."WP1122 / Moleculin, CNS Pharma, WPD PharmaMoleculin Announces Agreement to Produce WP1122 for Expanded Development of Potential COVID-19 and Oncology Drug Candidate (PRNewswire) - Jul 15, 2020 - "Moleculin Biotech, Inc....today announced that it has entered into an agreement with Sterling Pharma USA LLC for US production of WP1122 to support its expanded development efforts in preparation for submitting a request to the US Food and Drug Administration ('FDA') for Investigational New Drug ('IND') status for WP1122 for the potential treatment of COVID-19."Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for Prevention and Treatment of ARDS in Patients Hospitalized with COVID-19 (PRNewswire) - Jul 14, 2020 - "Akebia Therapeutics, Inc....today announced the initiation of an investigator-sponsored study evaluating the use of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS)....The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients....This study is being conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) application."Heron Therapeutics Announces Initiation of Phase 2 Clinical Study of CINVANTI for the Treatment of COVID-19 (PRNewswire) - Jul 16, 2020 - "Heron Therapeutics, Inc....today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19....The use of remdesivir through the Emergency Use Authorization and dexamethasone as standard of care are both permitted in the study."Daklinza (daclatasvir) / BMSHep C Sofosbuvir/Daclatasvir Combo Promising for COVID-19 (Medscape) - Jul 13, 2020 - "These findings are hopeful, 'provocative, and encouraging,' said Anthony Fauci, MD...But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on."Fauci is optimistic that a new treatment for Covid will be available by October (ThePrint) - Jul 17, 2020 - "US infectious disease expert Anthony Fauci said he expects results for a clinical trial on monoclonal antibodies, which can be used as a treatment to fight the virus....A monoclonal antibody is a laboratory-produced protein that can potentially be used to treat sick patients as well as for prophylaxis. Fauci, the top U.S. infectious disease expert, described them as 'precise bullets' that can be developed from antibodies from other people who’ve been infected and used as a treatment to fight the virus at multiple stages."
