Covid-19 roundup: Merck and Ridgeback report early data for an oral antiviral to fight the pandemic; Austria pulls a batch of AstraZeneca’s vaccine after patient death
A couple of months after scrapping its Covid-19 vaccine program, Merck has read out early data for an oral antiviral it’s developing with Ridgeback Biotherapeutics, which experts say could be the Tamiflu of coronavirus treatments.
The partners say molnupiravir — invented at an Emory University spinout — led to a reduction in positive viral culture in Phase IIa subjects, according to preliminary data. The study included 202 non-hospitalized adults who had Covid-19 symptoms within seven days of participation and tested positive for the virus. On day 5, researchers detected the virus in the cell cultures of zero of 47 molnupiravir patients, as opposed to 24% (or 6 of 25) placebo patients, Ridgeback and Merck announced.
The findings — while still early — back a secondary objective, according to the partners. They plan on reading out primary efficacy and safety endpoints and additional secondary objectives at an “upcoming medical meeting.”
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising and if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” said William Fischer, lead investigator of the study.
Experts compared the oral drug, which would be the first of its kind if authorized in the US, to Tamiflu, according to the Wall Street Journal.
“It’s tantalizing and interesting, but it’s not exactly 100% complete,” Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, told the WSJ. “What we need to confirm is that there’s clinical benefit.”
The companies said additional Phase II and II/III studies are underway.
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Roy Baynes, Merck Research Laboratories CMO, and senior VP and head of global clinical development.
Austria pulls a batch of AstraZeneca’s vaccine after patient death
Austria has pulled one batch of AstraZeneca’s Covid-19 vaccine from the shelves after a 49-year-old woman died of “severe coagulation disorders,” according to the country’s Federal Office for Safety in Health Care (BASG).
Another 35-year-old woman given the shot suffered a pulmonary embolism and is recovering, the BASG said in a statement. Both incidents occurred in people given shots from the same batch of vaccines in the Lower Austria district of Zwettl.
The BASG said there’s currently no evidence the cases are tied to the vaccine. But to be safe, the government yanked the whole batch and is conducting an investigation.
“Based on the known clinical data, a causal relationship cannot be established, as thrombotic events in particular are not among the known or typical side effects of the vaccine in question,” the BASG said. “The immediately initiated international analysis of side effect reports also shows no accumulation of similar case reports so far.”
Back in January, California’s state epidemiologist called for the suspension of more than 300,000 doses of Moderna’s vaccine after fewer than 10 people who received shots from the batch suffered possible allergic reactions. Moderna said at the time that it was “unaware of comparable adverse events from other vaccination centers which may have administered vaccines from the same lot,” PBS reported.
The suspensions come as vaccines are in extremely short supply, with some healthcare experts calling them “liquid gold.”
Last month, South Africa slammed the brakes on the rollout of AstraZeneca and Oxford University’s Covid-19 vaccine after data showed it did not protect against mild-to-moderate cases caused by the B.1.351 variant, which is now widespread in the country. The government later said it’s considering selling or exchanging the doses it’s already received.
According to a poll from YouGov, one in four German and French respondents said they’d refuse to take AstraZeneca’s jab if offered.
Vaccitech plans massive IPO, but Oxford could stand in the way — report
Vaccitech — the spinout behind Oxford University’s Covid-19 vaccine with AstraZeneca — is reportedly lining up a massive Nasdaq debut. But tension with the university has spilled over into public view, and could prove a challenge in the company’s IPO quest.
According to unnamed sources and documents reviewed by the Wall Street Journal, Vaccitech is shooting for a $700 million IPO valuation, and the S-1 could come as early as this year. Big-name players like Gilead and Lilly Asia Ventures have expressed interest in investing, the WSJ reported.
But Oxford, which owns 10% of the company, could make things a bit difficult for Vaccitech. Vaccitech created key technology behind Oxford and AstraZeneca’s Covid-19 vaccine, which it still owns the rights to. But it gave up direct rights to the vaccine itself, and is instead eligible for 24% of any royalties Oxford gets from vaccine sales, according to the WSJ.
Vaccitech now wants Oxford’s blessing to market its scientists’ early work on the vaccine’s development and manufacturing, the WSJ reported. And it wants to see the vaccine contract Oxford inked with AstraZeneca, which the company says includes obligations that are “key to valuing the company fairly and for regulatory disclosures.”
Oxford and its venture firm, Oxford Sciences Innovation, together own a more than 40% stake in Vaccitech. While some Oxford-affiliated investors prefer to list in London, Vaccitech is gunning for a New York listing. Oxford University is now in the process of changing its spinout rules, according to the WSJ.
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