EIDD-2801, the Merck drug now known as Molnupiravir, can be administered orally as a pill in an outpatient setting. The big gap that TrialSite advocates drug companies to fill in regarding COVID-19 care is the treatment at early onset of SARS-CoV-2, during the mild to moderate stage where today people diagnosed positive are simply sent home most of the time with no treatment. A number of outspoken physicians do advocate off label care. Now a drug developed at Emory’s non profit drug development organization DRIVE not only appears safe but also looks to reduce the COVID-19 infection to undetectable levels after just five day of administration, according to recent results from a Phase 2 clinical trial. Back in July, TrialSite reported on the Merck and Emory deal and suggested Merck was positioning to take out Gilead’s remdesivir lead in the market for COVID-19 antivirals. Given Gilead has generated over $3 billion in revenue in less than a year, the stakes are very large. In fact, so large TrialSite has speculated (but cannot prove) that’s one reason for Merck’s aggressive stance against its own ivermectin-based product, despite a growing number of trial results showing intriguing data. But the news that EIDD-2801 (again now Molnupiravir) is certainly good. Needed in the market are a mix of safe and efficacious antiviral or antiviral-like medications for this coronavirus. The stakes are enormous—many billions of dollars will be redirected from Gilead to Merck.
Recently, George Painter, PhD, CEO of Drug Innovation Ventures at Emory (DRIVE) and director of the Emory Institute for Drug Development, shared accurately that “There’s still an urgent need for an antiviral drug against SARS-CoV-2 that can be easily produced, transported, stored and administered.”
Upon onset of the pandemic, DRIVE moved into action repurposing a broad-spectrum antiviral drug it was developing targeting influenza and equine encephalitis. It was licensed to Ridgeback Biotherapeutics and then of course Merck and Ridgeback entered into their deal.
As shared recently by Emory, the drug actually interferes with SARS-CoV-2 replication in infected patients, similar to what some experts think is happening with ivermectin. However, more data is needed. The Merck and Ridgeback team report results from their trial will be shared when available and a Phase 2/3 clinical trial is underway.
Why will this Drug Take Remdesivir Revenues
Because people are not treated at home in an ambulatory or outpatient setting, some inevitably see their condition worsen. Those individuals end up in inpatient and hospital settings with more severe symptoms and progressing SARS-CoV-2 conditions. This is when they are administered remdesivir and possibly monoclonal antibodies.
Those advocating for ivermectin have done so because accumulating data reveals the potential for evidence to treat people at this early stage. Merck, having already committed to at least two proprietary pharmaceutical treatments, could not acknowledge ivermectin. TrialSite was quite critical as to their messaging, essentially discounting good research from investigators around the world.
However, this doesn’t take away from the huge potential Merck now faces with the results from the Phase 2 study. A safe and effective antiviral that can be used for home care targeting COVID-19 is worth many billions of dollars per year and Merck just may be knocking at that door.
Emory’s DRIVE has received over $20 million from the university in a foundational drive to build world class infrastructure for drug development for viral diseases of global concern.