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Monday, August 3, 2020

Rival drugmakers launch joint trial of medicines for COVID-19

Rival drugmakers AbbVie Inc, Amgen Inc and Takeda Pharmaceuticals Inc on Monday said they have begun treating patients in a trial to quickly show whether a drug from each company can be repurposed and used against COVID-19, the disease caused by the novel coronavirus.

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 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.
Hospitals have tried other anti-inflammatory drugs in COVID-19 patients, including Regeneron’s Kevzara and Roche Holding’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. 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.

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