Redhill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK
Mark L. Levitt, M.D., Ph.D., and Medical Director at Redhill, said: “We are quickly advancing the preparations for a global, multi-center powered Phase 2/3 study with opaganib for COVID-19. In line with the global shift from a focus on compassionate use programs to adequately controlled clinical studies, our highest priority is on generating robust data in a controlled setting for regulatory purposes. Following our submission of the Clinical Trial Application in Russia last week, we have submitted similar applications in the UK and Italy, and we are looking to expand the study to additional countries and start treating patients soon. This study, along with the ongoing Phase 2a study in the U.S., should allow us to enroll patients faster to evaluate the efficacy of opaganib against COVID-19 and bring this promising therapy one step closer to those who need it.”
In parallel, a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. is open for recruitment (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. To date, a total of 141 subjects have been dosed with opaganib in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications, in pharmacokinetic studies in healthy volunteers in the U.S., under the existing U.S. Food and Drug Administration (FDA) approved expanded access requests for oncology patients and under the expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the U.S. and ex-U.S.
TransCelerate Expands COVID-19 Clinical Trial Data Sharing to Include All Biopharma Companies and Biomedical Research Institutions
TransCelerate will expand the type of data shared to include data from both the investigational product and control arms of COVID-19 clinical trials. This announcement comes quickly following a decision last month to utilize the DataCelerate® platform to share control arm data from ongoing and planned COVID-19 clinical studies. DataCelerate® is a global cloud-based data-sharing platform that allows for de-identified, anonymized pre-clinical, and clinical data types to be requested and voluntarily shared. The DataCelerate® system and accompanying legal agreements provide an internationally compliant system protecting privacy rights in clinical data. COVID-19-related clinical data will accumulate in the DataCelerate platform and will be available for complimentary access to qualifying biopharmaceutical companies and biomedical research agencies.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design, and facilitate the implementation of solutions intended to drive the efficient, effective, and high-quality delivery of new medicines.
Low-cost dexamethasone hits the mark in COVID-19 study
The initial results from the study demonstrated that dexamethasone reduced deaths by one-third in patients on ventilation, and by one-fifth in patients receiving oxygen only. According to researchers, this means that one death would be prevented by dexamethasone treatment in around eight ventilated patients or around 25 patients requiring oxygen.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result,” said Peter Horby, professor of Emerging Infectious Diseases at the Nuffield Department of Medicine, University of Oxford, and one of the chief investigators for the trial. “This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed in finding an effective treatment is truly remarkable. It shows the importance of doing high-quality clinical trials and basing decisions on the results of those trials,” he added.
Biopharma Launches Trial Testing Nitric Oxide as COVID-19 Treatment
“Nitric oxide has shown potential against viruses through blocking both RNA synthesis and viral replication. Data include in vitro analysis of SARS coronavirus and four patients with coronavirus,” Henry indicated. The analyst described the New York-based company’s open-label study that is to be conducted at two sites. It will involve 20 patients who are hospitalized with COVID-19. To be randomized on a 1:1 basis, patients will receive standard supportive therapy alone or standard supportive therapy plus intermittent treatments of 80 parts per million (80 ppm) of nitric oxide over 40 minutes four times per day. Patients will be treated and evaluated for about seven days and then followed up at 30 days.
Henry highlighted that safety is the main focus of the U.S. study, as the maximum nitric oxide dose to be used in it is 80 ppm, which is “underdosed as antiviral therapy.” The Canadian trial to follow, however, will concentrate on efficacy as it will test nitric oxide doses up to 150 ppm. Data from the Canadian trial are expected sometime in Q4/20.
Moderna Phase III Covid-19 vaccine study to enroll 30,000 participants starting next month
One of the companies in the lead to develop a vaccine against the virus that causes Covid-19 has finalized the design of its protocol for the Phase III study slated to begin next month. Cambridge, Massachusetts-based Moderna gave details Thursday about the design of the protocol of the upcoming Phase III study, based on discussions with the Food and Drug Administration. Its vaccine against SARS-CoV-2, mRNA-1273, is currently in two clinical trials: a Phase I study sponsored by the National Institute of Allergy and Infectious Diseases and a Phase II study that the company itself is running.
The Phase III trial, which Moderna will conduct under collaboration with NIAID, will be randomized and placebo-controlled, enrolling about 30,000 participants in the U.S. Its primary endpoint will be the prevention of symptomatic Covid-19 disease, while prevention of severe disease and of infection by SARS-CoV-2 will be secondary endpoints. Dosing is expected to start in July, and participants will receive a dose of 100 micrograms, the dose determined based on results of the Phase I study. Moderna also announced data from its Phase I study, showing that participants developed antibodies, though the data only included a very small number of subjects and did not show whether those antibodies would lead to immunity against SARS-CoV-2.