By Peter Kenny
GENEVA (AA) - The Swiss pharmaceutical company Novartis said Monday it has reached an agreement with the U.S. Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease.
"Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence1,2,3 that hydroxychloroquine may help hospitalized patients with COVID-19 disease," Novartis said in a statement.
Hydroxychloroquine is an antimalarial drug currently studied by experts as a possible treatment of COVID-19.
The announcement came amid a massive effort to develop a vaccine for coronavirus in Switzerland, the U.K., U.S., and other countries within months and to release it to save lives.
The large trial sponsored by Novartis will be conducted at more than a dozen sites in the U.S..
The company plans to begin enrollment for this study within the next few weeks and said it is committed to reporting results as soon as possible.
Recently, Dr. Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases and a member of U.S. President Donald Trump's task force, has said a vaccine against COVID-19 would take 12 to 18 months to develop.
Novartis said it will also make its hydroxychloroquine intellectual property available to support broad access if the medicine is approved for COVID-19 and proves beneficial.
The drugmaker said it would donate 130 million tablets of hydroxychloroquine to supply global clinical research efforts if the medicine is proven beneficial against COVID-19.
Separately at a video press conference for the Geneva UN Correspondents Association on Monday, Dr. Martin Bachmann, an immunologist at the University of Bern and the U.K.'s Oxford University, said he is working with the Swiss company Saiba to develop a vaccine within months.
"We want to provide a solution for Switzerland and then for the rest of the world. I believe we have a realistic chance of being successful," said Bachmann.
Gary Jennings, a biochemist and COO from Saiba, said: "The plan is that we will finish the optimization of our lead vaccine candidates at the end of this month. We think we'd have a selected candidate.
"And we've also instigated the workup of the pilot process for the manufacture with the Zurich University of Applied Sciences. They're assisting us in the development of the pilot process."
The scientists said they believe they could have a vaccine ready to use on the entire Swiss population by October in the second and third phases of trials.
The teams use virus-like particles that are not infectious and are self-assembling structures that look like a virus, but they do not have any genetic information.
Using a coat protein of a virus, it often self-assembles into a virus-like structure, said Bachman.
After being first detected in Wuhan, China late last year, the new coronavirus has spread to 185 countries and regions.
It has killed more than 166,200 people and infected over 2.42 million, according to the U.S.’ Johns Hopkins University.