- September could bring crucial data on leading coronavirus vaccines and experimental treatments.
- Business Insider identified 10 key events that could happen in September in the race for COVID-19 vaccines and drugs.
- These events include data from top pharma companies like AstraZeneca, Pfizer, and Regeneron, as well as the start of clinical trials to test a spate of treatments and vaccines.
- For more stories like this, sign up here for our healthcare newsletter, Dispensed.
September is shaping up to be another busy month of research for drugs and vaccines to fight the coronavirus.
We could even find out for the first time whether a coronavirus vaccine works.
That’s a slim possibility but one that has been floated by executives at Pfizer and AstraZeneca, two pharmaceutical giants with late-stage clinical trials underway on vaccine candidates.
If data comes that shows whether these vaccines can prevent infection or disease, that would be far and away the most important event of the month. Crucial data on some leading potential treatments is expected by the end of the month as well.
Business Insider reviewed the research landscape and identified 10 key events that could happen this month.
1. We might find out if AstraZeneca’s vaccine works
The vaccine being tested by AstraZeneca and the University of Oxford could produce results from its late-stage clinical trial in September.
AstraZeneca has been running trials in the UK, South Africa, and Brazil to test its shot. In mid-June, CEO Pascal Soriot said, “If all goes well, we will have the results of the clinical trials in August/September.”
Data from different countries could be pooled together to determine whether AstraZeneca’s vaccine prevents infection or disease.
If the vaccine works, the Trump administration could make it available to some people via an emergency use authorization in October, the Financial Times reported.
AstraZeneca said on August 31 it was starting a late-stage trial of the vaccine in the US as well.
2. Pfizer might also have results from its late-stage vaccine trial
Meanwhile, Pfizer and BioNTech launched a 30,000-person trial of their vaccine in late July, hoping to have enough data to file with regulators around September or October.
Pfizer Chief Scientific Officer Mikael Dolsten said on a July 28 call that the study should have enough volunteers enrolled to take an interim look at the data in September or October.
The timing for both vaccines is highly dependent on unknowns, like how effective the vaccine is and how many people in the trial are getting sick. The high rate of viral spread in the US supports Pfizer’s ambitious timeline, Dolsten said.
3. Early data from Regeneron’s antibody drugs could demonstrate their potential
The scientific community has coalesced around antibody therapeutics as particularly promising treatment candidates against COVID-19. A crucial first look at human data on a leading contender is set to be revealed this month.
These drugs are clones of neutralizing antibodies, virus-fighting proteins the body makes that can thwart invading viruses like the coronavirus.
The most advanced programs are backed by Regeneron and Eli Lilly, with both in late-stage clinical testing. But these studies are taking longer than expected “because of a dearth of tests, overwhelmed hospitals and reluctant patients,” The New York Times’ Katie Thomas reported on August 14.
Even with those challenges, Regeneron executives plan to have early results in September. The data won’t definitively tell if the treatment works, but it could be a promising sign if it shows the drug lowered the amount of virus in people’s bodies.
“Despite the challenging environment in which these studies are being conducted, we are targeting to report initial virology and biomarker data from the treatment studies by the end of September, with clinical outcome data to follow as enrollment progresses,” George Yancopoulos, Regeneron’s chief scientific officer, said on August 5.
4. The largest healthcare company is set to become a front-runner in the vaccine race
Johnson & Johnson, the biggest healthcare company, is gearing up to provide initial data on its coronavirus vaccine. The data on its experimental shot should be ready in the second half of this month, Paul Stoffels, J&J’s chief scientific officer, said on the company’s latest earnings call. That data comes from a phase-one trial that started in late July.
5. J&J is hoping to start a late-stage vaccine trial in September
If the data shows that the vaccine is promising, J&J could quickly launch a massive late-stage study designed to determine if the vaccine works. Stoffels said trial, known as a phase-three study, would start in mid-to-late September.
Quickly moving into the final stage of clinical testing would vault J&J to having one of the most advanced candidates.
6. Pfizer advances its work on an oral antiviral drug
So far, treatment options for COVID-19 patients are severely limited. The few treatments that have been shown to work have modest effects or are useful for limited groups of patients.
Large drugmakers plan to advance COVID-19 drug candidates that can be taken orally and directly fight the virus. That means if they work, they could have a far-reaching impact in helping treat many coronavirus patients.
Pfizer CEO Albert Bourla has said his company hopes to have its antiviral drug in human testing by September.
7. Merck gets its oral antiviral into 2 large studies
Merck is also exploring an oral antiviral drug in collaboration with Ridgeback Biotherapeutics and plans to launch two large studies for its candidate MK-4482 in September, Roger Perlmutter, the company’s research chief, said on a July 31 earnings call.
Merck plans to study the drug in hospitalized and nonhospitalized patients.
8. Novavax kicks off a late-stage vaccine trial
Novavax is aiming to start a late-stage trial for its vaccine candidate in September.
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The Maryland biotech company has had a transformative year based around hopes for its COVID-19 shot, including a $1.6 billion funding deal with the US government. “Our goal is to initiate our first efficacy trial in September and conduct efficacy trials in multiple countries,” CEO Stanley Erck said on an August 10 earnings call.
9. Merck starts human testing for its vaccine
One of the largest players in the vaccine industry plans to start human testing as well. Merck expects to start trials for a vaccine candidate developed through the recent acquisition of Themis Bio.
10. Inovio starts a later-stage vaccine trial without US financial support
Finally, Inovio Pharmaceuticals plans to start a phase two/three study in September.
Unlike Novavax, this small biotech did not receive financial backing from Operation Warp Speed, making it unclear how the company will bankroll a costly trial. Inovio had recently planned to start the late-stage study in the summer but recently delayed the timeline to September.
This article was updated on September 1 with new information on AstraZeneca’s US vaccine trial.
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