Covid-19 roundup: Can AbbVie’s disappointing NASH drug cenicriviroc find success fighting cytokine storms?; Trump ally Chris Christie says he received Lilly's antibody cocktail
After getting passed down the line to AbbVie through a couple of biotech buyouts, the pharma giant is now in line to see if their drug cenicriviroc can score a success in the global war against Covid-19.
The NIH has selected this drug — which has proven underwhelming as a NASH-targeted therapy — as one of 3 it will test in a new adaptive study dubbed ACTIV-1 Immune Modulators, which is looking for new ways to fight off the cytokine storms that kill some patients.
The other 2 drugs selected from among 130 candidates are the high profile immune modulators Remicade and Orencia. So far repurposing existing drugs for the virus has often proved frustratingly disappointing. But nobody’s abandoned that approach yet. Armed with BARDA cash, investigators at the NIH say these 3 have profiles indicating their potential in combating one of the most threatening aspects of Covid-19. There’s also enough drug available to add an extra study.
All patients enrolled in the study will get remdesivir, now under a cloud after a new WHO study concluded it provides no evident benefit to patients, as well as convalescent plasma and dexamethasone — if the doctors involved believe it will help.
The late-stage drug has provided underwhelming evidence of efficacy in NASH — like most everything else thrown against NASH — after Brent Saunders picked it up at Allergan in the $1.7 billion Tobira buyout. AbbVie inherited the program with the rest of the Allergan pipeline following its own buyout.
The drug is a dual-receptor antagonist, targeting CCR2 and CCR5, which provides a rationale that it can help the worst off patients admitted to the hospital.
This isn’t the only adaptive trial examining how this drug performs against Covid-19. It was also tapped alongside Otezla and Firazyr for I-SPY COVID back in August, where researchers are looking for ways to fight acute respiratory distress syndrome.
Another possible remedy for cytokine storm has been presented by the anti-GM-CSF class of drugs, where Humanigen and GSK, among others, are testing drugs that have potential specifically to fight back against the most severe immune reactions. For Humanigen, the pandemic has offered a virtual rebirth for the company, after watching its shares trade OTC for some time.
Humanigen’s drug lenzilumab was chosen for another NIH study on Covid-19 earlier, which also added the IL-23 drug Skyrizi (risankizumab) from AbbVie and Boehringer Ingelheim. — John Carroll
China pushes experimental vaccines outside trials
Sinovac and China National Biotec Group may not be testing their Covid-19 vaccines, but the companies are already expanding its reach to the Chinese population through emergency use provisions.
As well as spawning a lightning-speed vaccine development program, the pandemic has triggered an unprecedented vaccination campaign in China, where at least 350,000 people are reported to have received an inoculation outside of clinical trials. Since the vaccines remain unproven, experts have cautioned that it could provide a false sense of security or worse, leading to surges in side effects that are not properly monitored.
Jiaxing, a city located just south of Shanghai with a population of over 3 million, is offering Sinovac’s experimental vaccine to high-risk groups and residents who have “emergency needs.” The price, local media reported, is RMB$200 ($29.87) per shot for a two-dose regimen.
China National Biotec Group, on the other hand, is offering its jabs (it’s developing two) for free to students who are studying abroad — much as it gave access to overseas workers of state-owned enterprises and medical workers within the country.
More than 168,000 people had signed up for the program online and over 91,000 are being considered, AP reported, citing a notice on CNBG’s website that’s since been removed.
In comparison, its Phase III trials are enrolling a total of 40,000 volunteers across the United Arab Emirates, Bahrain, Peru and Morocco. Sinovac, which is conducting trials in Brazil and Indonesia, among others, is enrolling similar numbers. — Amber Tong
Trump ally Chris Christie says he received Lilly’s antibody cocktail
When he was hospitalized for Covid-19, President Donald Trump said he asked for Regeneron’s experimental antibody cocktail — and received it. And now one of his longtime allies revealed he’s received a rival antibody treatment from Eli Lilly.
Chris Christie, the former governor of New Jersey, was believed to have been infected at the Rose Garden ceremony that Anthony Fauci has called a super-spreader event. Having recovered from the infection — after 7 days in intensive care — he thanked his doctors and “the manufacturers of Remdesivir and the Eli Lilly monoclonal anti-body cocktail for giving me access to their extraordinary treatments.”
Trump, who was also given remdesivir, had since lavished praise on both Regeneron’s and Eli Lilly’s drugs, promising to authorize them quickly and make them available for free to the American public.
Both Trump and Christie had secured access through compassionate use requests, something biopharma companies don’t typically like and are not obliged to comply.
As the drugs are still being tested in clinical trials and not yet widely available — Regeneron has 50,000 doses currently while Lilly expects to have 100,000 some time in October — bioethicists and watchdogs have questioned the ethics behind giving Trump special access.
“When it’s the president of the United States, of course, that gets — obviously — gets our attention,” Regeneron CEO Len Schleifer had told Katie Thomas at the New York Times.
With Christie, however, the stakes appear different. It is not immediately clear what standards Lilly applied in granting his request.
Lilly’s program is under a cloud of uncertainty after the NIH halted a trial testing its antibody, which was co-developed with AbCellera, over a safety concern — while FDA inspectors took issue with quality control at a manufacturing plant. — Amber Tong
First authorized vaccines may be met with reluctant Americans, poll suggests
About 70% of registered voters surveyed said they would take a Covid-19 vaccine, although many want to wait until it has been available for a while to see if there are major problems or side effects, a new Wall Street Journal/NBC News poll shows.
The survey found that 20% of respondents said they would take a vaccine as soon as one becomes available, while about half the respondents wanted to wait until they learned more information about the shot.
The latest results echo earlier sentiments amid a campaign to develop immunizations at unprecedented speed and come after accusations of politicization from all sides. Critics have lambasted President Donald Trump’s public promise to deliver a vaccine by Election Day and sounded alarm on the pressure he appears to be pushing on FDA commissioner Stephen Hahn — while Trump has suggested without evidence that there’s a “deep state” working inside the agency to delay a vaccine authorization. — Amber Tong
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