Covid-19 roundup: Trial of Trump's favorite Covid-19 drug nixed on early death risk; Is Anthony Fauci on thin ice with the president?
A study involving one of President Trump’s favorite Covid-19 drugs had to be halted early after researchers determined that the high dose of the treatment was linked to a higher risk of death.
Brazilian researchers had planned to enlist 440 patients to test chloroquine — closely connected to hydroxychloroquine — in infected patients. But researchers quickly spotted the safety issue. The abstract of their published study concluded:
The high dose CQ arm presented more QTc>500ms (25%), and a trend toward higher lethality (17%) than the lower dosage.
Investigator Marcus Lacerda told the New York Times in an email over the weekend that “the high dosage that the Chinese were using is very toxic and kills more patients.”
The Times also reported that the researchers scrapped the study, ending testing on the lower dosing as well, after determining they wouldn’t have enough patients to determine safety and efficacy.
Trump has sparked widespread criticism of his repeated statements pointing to the potential of hydroxychloroquine and chloroquine — both used against lupus and other autoimmune diseases in fighting the pandemic as patients and doctors grow more desperate to find meds that can work.
“What do you have to lose? I’ll say it again: What do you have to lose? Take it,” he said about hydroxychloroquine a few days ago. “I really think they should take it.”
Those remarks in turn have sparked considerable pushback from experts who want to see hard data before they start offering this drug to a mass number of patients. The Washington Post’s fact-checking team offered this conclusion today:
In particular, Trump’s incorrect comments on the drugs and his role in advocating for their use, based on minimal and flimsy evidence, sets a bad example. His advocacy for this unproven treatment provides potentially false hope and has led to shortages for people who rely on the drugs. The president earns Four Pinocchios.
— John Carroll
Is Anthony Fauci about to be fired?
Over the weekend President Trump RT’d a Tweet urging the ouster of NIAID chief Anthony Fauci after the country’s top infectious disease expert said that the president could have done more to put the brakes on the Covid-19 pandemic and save lives.
Cue a furious online tussle between fierce supporters of Fauci’s plain spoken advocacy of data and science over the president’s backers, who prize loyalty above all else. The hubbub has caused “firing Fauci” and #SaveFauci to trend online.
Fauci is also advocating a cautious, go-slow approach to reopening the US economy, while Trump appears to favor going big and going fast.
— John Carroll
Ensure hydroxychloroquine access for lupus patients, advocates appeal to Azar, Hahn and Fauci
No sooner had the FDA granted emergency authorization of hydroxychloroquine and chloroquine than it began to note that the two drugs — commonly used to treat malaria and a range of autoimmune diseases — were in shortage. And now a group of concerned lupus researchers are urging the government to protect supply of their much needed medications.
In contrast to its unproven utility against Covid-19, hydroxychloroquine “has been proven to mitigate SLE disease activity and to prevent flares,” a group of experts convened by the Lupus Research Alliance noted in an open letter. “It reduces joint pain, rashes, and thrombotic events, and prolongs survival.”
Led by Gary Koretzky, chair of the Lupus Research Alliance, they urged FDA commissioner Stephen Hahn, HHS secretary Alex Azar and NIAID director Anthony Fauci to enact measures to ensure that lupus patients would continue to have access to this drug — even as pivotal trials are underway to test whether it can fight coronavirus infections. Hydroxychloroquine is the most commonly prescribed med for systemic lupus erythematosus.
If the drug proves to be efficacious in both conditions, every effort should be made to ensure that hydroxychloroquine is available to everyone whose health requires it. Perhaps, now is the time to begin planning for that possibility. — Amber Tong
‘(T)hey were completely oblivious to the biggest thing that was about to shatter their world.’
The Biogen outbreak has become notorious on social media as legions of online critics point to their annual strategy session at the Marriott Long Wharf for promoting the spread of coronavirus in the US. Now the New York Times weighs in with its own assessment of the big biotech’s role in the outbreak.
We know that 2 senior company execs were infected at the meeting, which drew in staffers from Europe, but the company remains grimly determined not to identify who spread the virus at the Cowen conference days later. That includes CEO Michel Vounatsos, who won’t even say if he’s been tested for Covid-19.
I had a chance to weigh in on the article, saying:
“The smartest people in health care and drug development — and they were completely oblivious to the biggest thing that was about to shatter their world.”
As I also noted to the writers, it’s one thing for Biogen to have been blindsided by the burst of infections at their meeting, as the pandemic was brewing. But by the time of the Cowen meeting just days later, while Vertex and Seattle Genetics were pulling out, senior execs can be fairly criticized for not being more cautious as it became apparent that the outbreak was headed here.
One day top execs may be more transparent about the danger they posed to their staff, and the country. — John Carroll
Celltrion plunges into Covid-19 work in search of a “super antibody” and cocktail therapy
Working with the Korean CDC, Celltrion says it has identified hundreds of antibodies with potential in treating Covid-19 and now plans to begin animal testing in search of a “super”antibody or a cocktail that could be used to fight serious infections.
Researchers around the globe have been working on discovering antibodies that are particularly suited to the pandemic fight. For now, Gilead leads that race with its repurposed remdesivir, but the debate over its full potential won’t be decided until the company reads out pivotal data in the coming weeks and months.
Ki-Sung Kwon, Head of R&D at Celltrion, said:
“We are bringing our full resources and expertise to overcome this global health crisis and are glad to have identified these antibodies sooner than previously expected. These antibodies can recognise multiple epitopes, thus increasing the probability of nonspecific antigen binding. Given the expedited development process of our antiviral antibody treatment, we anticipate moving to first-in-human clinical trials in July. We are also on track with the development of a ‘super antibody’ or ‘an antibody cocktail’ and the launch of a rapid self-testing diagnostic kit in the summer of this year.” — John Carroll
Singapore restrictions force Aslan to pause enrollment, ponder a switch to Australia
You can add Aslan $ASLN to the long, long list of biotechs enduring trial delays due to the outbreak.
After repeated setbacks in the clinic, the Singapore-based biotech says that it is pausing recruitment for a study of ASLAN004 in moderate to severe atopic dermatitis. The company said local restrictions forced them to halt enrolling more patients, adding that they’re looking at switching their trial focus to Australia — where researchers and CROs have long held close ties to Asian developers. — John Carroll
NIH adds Eli Lilly’s Olumiant to the master protocol for Covid-19
As Big Pharmas race to deploy their approved anti-inflammatory drugs in the treatment of patients with serious Covid-19, Eli Lilly is throwing Olumiant (baricitinib) into the mix.
The NIH has added the rheumatoid arthritis drug to its master protocol dubbed Adaptive COVID-19 Treatment Trial (ACTT), the first since they began the trial with Gilead’s remdesivir. Lilly said results are expected in two months.
“Lilly is moving at top speed and using all available resources to help fight this pandemic,” said Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories.
In addition to testing Olumiant as part of an NIH-led trial, the company also plans to move LY3127804 into Phase II. The investigational monoclonal antibody blocks angiopoietin 2 (Ang2), a growth factor they say is elevated in patients with acute respiratory distress syndrome. As with a number of experimental agents in the moderate to severe setting, the goal is to reduce the progression to ARDS or the need for mechanical ventilation.
A month ago Lilly kicked off a collaboration with Canadian biotech AbCellera to discover antibodies that can fight the viral infection, eyeing first-in-human testing by late July. — Amber Tong
Gilead posts early remdesivir data, drawing a cheer
Results from a small, single-arm study involving 53 compassionate use cases of severely afflicted Covid-19 patients suggest Gilead’s hotly anticipated antiviral, remdesivir, might be inducing clinical improvement. Although the benefits have to be borne out in ongoing Phase III studies, SVB Leerink analyst Geoffrey Porges believes the drug should be available for limited use by mid-May. (Endpoints link)
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