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 The COVID-19 pandemic is an "all hands on deck moment," David Reese,
Amgen's research and development chief told Reuters. "We wanted a
trial to be able to quickly sift through multiple agents and
prioritize."
The study is a collaboration among pharmaceutical industry members
of the recently-formed COVID Research & Development Alliance,
Quantum Leap Healthcare Collaborative, a partnership of medical
researchers and investors, and the Food and Drug Administration.
The first segment will test whether Amgen's psoriasis drug Otezla,
Takeda's anti-inflammatory Firazyr and AbbVie's cenicriviroc, which
has been tried in patients with HIV, will help with the overactive,
and potentially damaging, immune response that sometimes happens in
patients with severe COVID-19.
The study's "adaptive platform" means several treatment candidates
can be tested at the same time, with the most promising moving
forward and the least promising dropping out, Quantum Leap
co-founder Dr. Laura Esserman told Reuters.
"We could have some results in as early as six weeks," she said,
adding that additional drugs will soon be added to the roster.
Company officials said Otezla may be able to suppress inflammation
from an overactive immune response; Firazyr may help limit fluid in
the lungs; and cenicriviroc, which blocks activity of certain immune
system cells, could reduce the severity of acute respiratory
distress caused by the virus.
The drugs are being dosed in combination with Gilead Sciences Inc's
<GILD.O> antiviral drug remdesivir and generic steroid dexamethasone,
both of which have been shown in rigorous trials to help COVID-19
patients and are now considered to be standard care, Dr. Esserman
said. A comparison group of patients will be given remdesivir and
dexamethasone alone.
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Hospitals have tried other anti-inflammatory drugs in COVID-19 patients,
including Regeneron's <REGN.O> Kevzara and Roche Holding's <ROG.S> Actemra, but
trials of both arthritis drugs failed to show effectiveness. Roche is continuing
to test Actemra in combination with remdesivir.
The National Institute of Allergy and Infectious Diseases' ongoing adaptive
COVID-19 trial is studying remdesivir in combination with Olumiant, an arthritis
drug sold by Eli Lilly & Co <LLY.N>. Those results are expected next month.
Since the outbreak began seven months ago, so far killing more than 675,000
people worldwide, hundreds of clinical trials have been launched around the
world to test whether existing drugs or experimental compounds could be
effective treatments.
"There are a huge number of trials that for all the best intentions have been
stood up around the world, but many are smaller - what we would call
underpowered - and will not provide definitive answers," Amgen's Reese said.
(Reporting By Deena Beasley; Editing by Aurora Ellis)
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