Here Are the Leaders in the Race to Develop a COVID-19 Pill

COVID-19 antibody therapies available right now require infusions or subcutaneous injections. However, a more convenient type of therapy could be on the way. In this Motley Fool Live video recorded on Sept. 22, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss the leaders in the race to develop a COVID-19 pill. (Note: This recording was made prior to Merck's (MRK 0.10%) announcement on Friday of positive results from a late-stage study of its oral antiviral therapy molnupiravir.)

Keith Speights: RedHill Biopharma's (RDHL -1.85%) oral COVID-19 candidate recently just flopped in a phase 3 study. But there are several other oral COVID antiviral therapies that are in development. In your view, which companies appear to be the leaders in the race to develop a COVID-19 pill?

Brian Orelli: Yeah, there are really three pills. Merck and Ridgeback have molnupiravir. They're expecting data later this year in outpatients, and then for post-exposure prophylaxis in the first half of next year. Pfizer (PFE -0.19%) has another drug that goes by the code-name PF-07321332.

Speights: What was that again, Brian? [laughs]

Orelli: The data for that in outpatients is also expected later this year. Then Roche (RHHBY -2.24%) and Atea (AVIR -0.80%) have a drug called AT527 -- a lot easier to say. That data in outpatients is also expected later this year. I think it's a three-horse race.

In theory, maybe all of them work. I think Merck's and Ridgeback's wasn't necessarily designed specifically for the coronavirus that causes COVID-19. I believe Pfizer's was, so maybe it has a slight advantage, but we have to wait and see about the actual data. I think this is a difficult space to invest in somewhat from obviously the three-way competition, but also because of the endpoints.

A lot of companies have had trouble actually proving that their drugs actually help patients. Do you do look at viral levels, or do you look at "does it keep them out of the hospital?" All those different endpoints can affect your actual outcomes of whether you can prove your drug works. Whether it actually works is completely different question. It's just whether you can prove your drug works.

I think that it's a difficult space for investors to invest in, and then of course, all three of those companies -- Merck, Pfizer, and Roche -- are obviously all really large companies. Adding one additional drug, even if it has a billion-dollars-plus in sales potential isn't going to necessarily move the needle that much on the revenue side.

Speights: Those are really good points, Brian. I did see that Pfizer is projecting that, assuming it's phrase 3 studies go well, Pfizer has projected that it could file for EUA for its COVID-19 pill, perhaps by the end of this year. So this is a story that is probably going to develop more quickly than you might even think because of the EUA path here.

I would think that if any of these pills do get authorization, and again, like you said, there's an uphill climb to prove that they actually work, but if they do win authorization or ultimately approval, they could bring in a big chunk of sales.

Orelli: I think we saw what Regeneron (REGN -0.09%) did maybe to $2.2 billion in sales to the US government. That's infused drug and these are oral drugs which are obviously a lot easier to take, and so you can expect that their use might go up, and then their manufacturing is probably easier. I would expect that they can probably make more of it, and that would help them with sales.

Speights: I would even see these pills being taken by people who are fully vaccinated too, because of the vaccines aren't 100% effective, and so if there's a post-exposure prophylaxis that has been proven to be effective, then you could see both unvaccinated and vaccinated people taking these pills -- again, if they make it to market.

Orelli: Yeah. Again, giving people a pill versus having them sit in an infusion center -- if they've been exposed then you're going to have to take a lot of more precautions to keep them isolated, and so that makes things difficult, where if you [can] just give them a pill, they can just go take it at their own house. I think that makes it a lot easier in the prophylaxis category as well, but we'll have to see what the data pans out there.