Ahead of today’s R&D Day event, expected to start at 8:00 am ET, Moderna (NASDAQ:MRNA) says it plans to enter the seasonal flu business for influenza types A&B.
On the COVID-19 front, its large-scale Phase 3 clinical trial evaluating mRNA-1273 has now enrolled 25,296 participants.
https://seekingalpha.com/news/3614896-moderna-to-enter-seasonal-flu-vaccine-business
Rigel Pharmaceuticals (NASDAQ:RIGL) rises 14% in premarket, in reaction to commencement of a Phase 2 trial of fostamatinib, its oral spleen tyrosine kinase inhibitor, for the treatment of hospitalized COVID-19 patients.
The study is sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH), in collaboration with Inova Health System.
Fostamatinib, marketed in the U.S. as TAVALISSE tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (characterized by abnormally low levels of platelets).
The study will enroll ~60 patients who require supplemental oxygen. Primary objective of the study is to evaluate the safety of fostamatinib compared to placebo in COVID-19, secondary objective include early efficacy and clinically relevant measures of disease progression.
Treatment will be administered orally twice daily for 14 days, with a follow-up period to day 60.
A drug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.
The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.
“This is a good start,” said Eric Topol, the director and founder of the Scripps Research Translational Institute. “A lot is pinned not only on Lilly but on the whole family of these [monoclonal antibodies], because even though they’re expensive and they’re not going to make a gajillion doses, they could make a big difference in the whole landscape of the pandemic.”
Lilly, which is developing the drug with the biotechnology firm AbCellera, tested three doses of its antibody against placebo in a trial enrolling about 450 patients recently diagnosed with mild to moderate Covid-19. The middle dose, 2,800 milligrams, met the trial’s primary goal of significantly reducing patients’ levels of SARS-CoV-2 after 11 days.
But other doses of the drug did not meet that goal, including a higher dose of 7,000 milligrams and a lower one of 700 milligrams. That could raise the risk that the benefit was due to chance, because normally one expects a medicine to become more effective as the dose increases, known as a dose response.
In a statement, Lilly said the problem may have stemmed from how the study chose to assess how much virus was detectable after 11 days. Most patients, including those who received placebo, had almost no virus at that time point. The company said that an analysis at day three showed the lower viral levels among those who received the antibody.
In a more tantalizing finding, the medicine also appeared to reduce patients’ odds of ending up in the hospital. Just 1.7% of patients who received the drug, called LY-CoV555, eventually went to the emergency room or were hospitalized, compared with 6% of those who took placebo. That amounts to 72% relative reduction in risk.
Those hospitalization data, though, are from a small number of patients, again increasing the odds that the finding won’t hold up with further study. Five of 302 patients on LY-CoV555 were hospitalized, compared to nine of 150 patients who received placebo. Lilly declined to confirm the difference is statistically significant, citing the need for full publication of the results.
“This is extremely exciting, and maybe a pivotal moment in the fight against Covid-19, said Daniel Skovronsky, Lilly’s chief scientific officer. “I think this should give us confidence that neutralizing antibodies are going to be an important part of the solution for ours and other companies, and that we will win the fight against Covid-19 through medicine and innovation.”
Skovronsky noted that studies of the antibody began only six months ago, and said that, although two doses missed on the 11-day endpoint, the antibody’s impact on symptoms and hospitalization gave him confidence in the result. He said that Lilly will share the results with regulators such as the Food and Drug Administration, and hoped to have discussions about a possible emergency use authorization (EUA).
“We will be discussing with regulators what the appropriate next steps are,” Skovronsky said. “So, of course, those discussions will include additional clinical trials as well as other options such as EUA. It’s a small dataset for sure, we we have 450 patients in this data set, but the magnitude of the impact on a hard end point years is very exciting and potentially meaningful for patients.”
Topol said that he does not think an EUA would be justified. “I don’t think it would qualify to even consider that,” he said. “That’s encouraging, but that’s different from saying it’s ready for emergency approval.”
The antibody led to no serious side effects, Lilly said, and adverse reactions were similar among patients regardless of whether they received placebo or any dose of LY-CoV555.
The results, which have not been peer-reviewed, came from an interim analysis of an ongoing study. The trial, called BLAZE-1, will also test a second antibody in combination with LY-CoV555 and enroll about 800 patients in total. Lilly has promised to publish all of its results in a peer-reviewed journal at a later date.
Lilly is conducting larger tests of the antibody, including one study in using the antibodies to prevent infection in nursing homes that is using recreational vehicles to provide on-site hubs for running the clinical trial. That study is being run with the National Institute of Allergy and Infectious Disease.
So far, only a handful of drugs have shown a benefit in randomized controlled trials against Covid-19. Those include remdesivir, developed by Gilead, and the steroid dexamethasone, as well as baricitinib, another Eli Lilly drug, which the company said Monday sped improvement of hospitalized patients by one day in a study being run with NIAID.
Regeneron Pharmaceuticals, which is developing a combination of two antibodies to treat Covid-19, is expected to have preliminary data from a placebo-controlled trial later this month. Like Lilly, Regeneron’s antibodies are designed to target a key protein on the surface of SARS-CoV-2 that allows the virus to enter human cells and replicate.
China and the United Arab Emirates have seen some positive results in their Phase III COVID-19 vaccine trials, Chinese foreign ministry spokesman Wang Wenbin told a news briefing in Beijing on Wednesday.
The United Arab Emirates on Monday granted emergency approval for use of a coronavirus vaccine, six weeks after human trials in the Gulf Arab state started.
Serum Institute of India has received Indian regulatory approval to resume local clinical trials of AstraZeneca’s potential COVID-19 vaccine, a source familiar with the matter said on Wednesday.
The approval came from the Drugs Controller General of India (DCGI), according to the source.
AstraZeneca has resumed British clinical trials of the vaccine, one of the most advanced in development for COVID-19, after they were paused earlier this month following a serious side effect in a trial participant.
Trials have also resumed in Brazil and South Africa, but remain on hold in the United States.
Indian regulators had allowed Serum’s trials of the AstraZeneca vaccine to resume under certain conditions, including increased safety monitoring and informing volunteers about new findings, a DCGI source said.
“We allowed them (to resume trials) after a detailed discussion with authorities in the UK and the company itself,” the source added.
Russia’s sovereign wealth fund said on Wednesday it will supply India’s Dr. Reddy’s Laboratories with 100 million doses of the Sputnik-V vaccine against COVID-19 once it receives regulatory approval in India.
The Russian Direct Investment Fund (RDIF) added that it had agreed to cooperate on clinical trials and the distribution of the vaccine with the Indian firm.
Merck KGaA on Wednesday backed its outlook for the full year, and said it is currently focusing on organic growth and lowering its debt.
The pharmaceuticals and chemicals company continues to expect slight to moderate organic growth in full-year net sales and Ebitda pre, or earnings before interest, taxes, depreciation and amortization before one-time items.
This equates to sales of 16.9 billion to 17.7 billion euros ($20.02 billion-$20.97 billion) and Ebitda pre of EUR4.45 billion to EUR4.85 billion.
As for its health-care core business, Merck confirmed its target of around EUR2 billion in own pipeline sales by 2022.
For its life-science business, Merck forecasts 6% to 9% average yearly organic sales growth in the medium term.
The company said it is currently prioritizing organic growth and lowering its debt until 2022.
