Kathleen Mullane, University of Chicago infectious disease specialist, said, “The best news is that most of our patients have already been discharged, which is great. We only had two patients perish.”
The University of Chicago Medicine recruited 125 patients with the virus into Gilead’s two late-stage clinical trials, 113 of which were severely sick.
Gilead intends to enroll 4,000 people in its trials.
The firm’s clinical trial results involving patients with severe cases of the virus are expected this month while the data from trial testing patients with moderate symptoms are expected to be released in May.
We remind that remdesivir is not a prophylactic vaccine. It is a drug to be given only to people already infected with the virus.
We definitely need a vaccine to protect every human being living on our planet.
Several firms are working on vaccines. The first of these vaccines to be tested in human clinical trials is the one which Moderna has created and developed at an unprecedented speed.
Moderna’s (MRNA) stock also rallied today following its announcement of an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development of the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
BARDA will fund the advancement of mRNA-1273 to FDA licensure. A Phase 1 study of mRNA-1273 is being conducted by the National Institutes of Health (NIH). The Phase 1 open-label study, which began on March 16, 2020, has completed enrollment of the original study with 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg and 250 µg).
The NIH recently amended the Phase 1 protocol to include an additional six cohorts with three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing.
If supported by safety data from the Phase 1 study the 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.
BARDA funding will support these late-stage clinical development programs as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response.
To support the scale-up Moderna plans to hire up to 150 new team members in the U.S. this year. This includes a significant increase in its skilled manufacturing staff to expand manufacturing capacity from 2 shifts per day 5 days a week to 3 shifts per day 7 days a week, for engineers to manage process scale-up and clinical and regulatory staff to support clinical development.
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” said BARDA Director Rick Bright, Ph.D. “Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced-Phase clinical trials and production scale-up while Phase 1 is underway could shave months off the development of COVID-19 vaccines.”
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on Friday, April 17, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5115809. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.
This news promises to defeat COVID-19 thanks to America’s faith, courage and revolutionary science.
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Why Gilead’s and Moderna’s Stocks Rallied Today
Gilead (GILD) stock soared after market hours adding $11 to the $1.90 the stock had gained during trading hours. Investors’ enthusiasm was raised when very promising results came out of a clinical trial for Gilead’s drug remdesivir given to COVID-19 infected people.
According to the news the University of Chicago’s Phase 3 trial results demonstrated that most COVID-19 infected patients treated with Gilead’s drug remdesivir experienced fast recoveries from fever and respiratory symptoms and were discharged in less than one week, reported by Health-care publication STAT News.