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Multiple Phase III data for oral pills for treatment of COVID are due NT and by YE from
MRK, PFE, Roche. We see some chance of success (40-50%) but prior clinical data is
sparse at best and if they work, we see mostly incremental benefit. This is net positive
and helps in the fight and might be a headline risk to antibodies (ADGI) and vaccines
(MRNA) but these will still be most important and orals are unlikely to significantly
change investment theses.
Big Picture: Several oral therapies for the treatment of COVID-19 are expected to have
Phase III data in coming months. Although they are not a no-brainer to work at all,
based on some limited data (sparse viral load reduction data) and understanding the
mechanism of action (inhibiting replication of virus), there is a reasonable chance at least
one of the drugs from MRK, PFE or RHHBY will work and hit the primary endpoint (reduce
symptoms, faster time to resolution, etc). This would be a positive in the fight against
COVID since it would mean we could have an easy-to-use oral treatment soon available.
We note the US govt is very interested in having oral pills and previously prepared just in
case and purchased 1.7M courses of MRK's oral (we think this trial reads out first soon).
MRK has said it expects to have plenty of drug with 10M courses (or 100 million pills)
before YE. We think PFE's may be more likely to work based on mechanism but if they
work we dont expect them to be huge transformative benefits and rather "incremental"
to reduce symptoms and maybe 1-2 days faster resolution of symptoms (think Tamiflu
like pills maybe).
We think there ~40-50% chance one or more oral COVID-19 antivirals will work (mostly
in outpatient setting, not likely in hospitalized setting). We think MRK Phase III for
prevention of COVID-19 hospitalization/death in high risk CV-19+ pts comes first. Two
positives: 1) Phase II data showed a meaningful viral load reduction by Day 5-7 of 0.5 -1.5
log and 2) MRK modified the Phase III to enroll pts with fewer days of symptoms (< 5 days
of symptom duration vs. < 7 days in the prior Phase II) providing earlier chance and more
room for drug to work. On balance though: 3) viral load reduction is not 100% correlated
with disease alleviation and pts can resolve w/o therapy at different time points anyway,
4) the study will likely be impacted by enrolling pts infected w/ Delta which is arguably
more virulent.
Oral drugs could expand the treatment armamentarium. While difficult to estimate
effectiveness given minimal data released (pharma is just plowing ahead since it is worth
a shot to run the Phase III), we believe oral therapies will be less effective than antibody
therapies. Regardless, given oral administration (twice a day for 5 days) and ability to
use in outpatient setting, oral therapies do have a large opportunity and will be helpful.
However, the key to the battle remains higher levels of vaccination, booster shots to keep
away resistance and variants and ongoing infection (not just severe disease), and strong
treatments including antibodies (ADGI, etc).
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