As promising as vaccines may seem right now, they cant help patients who are already infected with the novel coronavirus. The world still lacks a COVID-19 cure that can speed up recovery, prevent complications, and reduce the risk of death. Remdesivir helps in some cases, but its expensive, scarce, and difficult to make. Dexamethasone is cheap, but isnt enough to save every patients life either. Blood thinners can reduce the risk of coagulation and eliminate some complications, but theyre not a COVID-19 cure by themselves.

Several other promising antibody therapies are in the works, and some of them are already being studied in human trials. Merck has an antiviral drug in testing, and the company is expected to start large pivotal studies in September for an oral medicine to rival remdesivir. However, theres some controversy around this potential coronavirus treatment.

We will be embarking, probably in September, on very large pivotal studies, and so those are going to be the important ones, Merck president Roger Perlmutter said during the companys Q2 earnings call, via CNBC. The drug is known as MK-4482, and its being developed with Ridgeback Biotherapeutics. The report notes that Merck doesnt want to dribble out data on the drugs performance in Phase 2 trials, according to Perlmutter. Thats certainly strange.

The good news about MK-4482 is that because its an oral drug given in capsules, it can be easily administered from the time that people have symptoms, Perlmutter said. Its unclear whether theres any bad news. The executive didnt say how effective the drug is, but revealed that the goal of future studies would be to prove that the drug can reduce the recovery time and prevent complications.

The company also has a couple of vaccines in the works that will hit clinical trials in the near future.

MK-4482 was the most advanced COVID-19 therapy from Merck, per a C&EN report in late May. But MK-4482 wasnt always known as, well, MK-4482. BioSpace says the antiviral candidate was known as EIDD-2801 before being renamed under Merck. CNBC makes no mention of the compounds controversial history.

Getting back to C&EN, the May report said that Ridgeback was testing EIDD-2801 at the time in Phase 1 trials. The origin of the drug is Emory University, however:

The most advanced of Mercks three new programs is EIDD-2801. The small-molecule drug candidate was developed before the pandemic by scientists at Emory University looking for molecules that could inhibit the replication of several viruses. In March, Emory scientists discovered that the compound could also inhibit the replication of SARS-CoV-2, the virus that causes COVID-19, in human cells grown in the lab.

Emory licensed it to Ridgeback, which then partnered with Merck.

EIDD-2801 targets a viral enzyme called RNA-dependent RNA polymerase that stops the virus from copying its RNA genome, effectively preventing it from multiplying inside a human cell after infecting it. If effective, that would be a huge step in treating COVID-19. Remdesivir goes after the same enzyme, but Gilead Sciences medicine needs to be administered intravenously. Mercks drug can be taken orally.

This brings us to the controversy around the drug as explained by C&EN (emphasis ours):

EIDD-2801 has been viewed as a potential competitor to remdesivir, although a contentious one, because similar compounds are mutagenic in animal studies, meaning they produce birth defects. Rick Bright, who was removed from his position as head of the US Biomedical Advanced Research and Development Authority (BARDA) in April, was reluctant to provide funding for the drug for this reason, according to an 89-page whistleblower complaint Bright filed after being fired. Mercks investment in EIDD-2801 can be seen as a vote of confidence in the compound.

Brights concerns began in November 2019, more than one month before China disclosed the first COVID-19 cases in Wuhan ScienceMag has that story:

Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredients bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. Thank goodness someone is raising the red flag, about EIDD-2801, Schinazi says. You dont develop a drug thats mutagenic. Period.

Before a drug is approved, regulators have to see that its effective and safe after passing Phase 3 testing. The same applies to MK-4482. Rick Bright may have had concerns about the drug, but that doesnt make it unsafe for use. That said, the lack of Phase 1 results from Merck and the name change do seem strange. All the other promising drugs and vaccines that are in testing produced results for the public early during their human trails.

Emory did produce results in early April for preclinical trials that showed when used as a prophylactic, EIDD-2801 can prevent severe lung injury in infected mice. That study is available at this link.

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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Merck to start pivotal study of controversial remdesivir alternative in September - BGR