Ok, I just read through a deep dive on remedsivir and the ongoing trials.
Takeaways:
1. In vitro, it is potent vs SARS-COV-2 and the trial dosing is about as high as is safe, because adverse effects show up at higher doses
2. A few scattered individual patients treated with the drug had so-so results
3. About 17 Diamond Princess patients were treated with the drug in Japan, with seemingly good results, these were severe cases in older persons; no real data available
4. Some small “trials” in China yielded poor results, but turns out those did not use actual GILD-supplied drug, it was made by others (see manufacturing discussion below) so pretty meaningless
5. First real trial to read out will be a large Chinese trial (400+ patients planned). This trial is taking longer to complete than hoped, mostly because currently there aren’t as many severe cases in China as expected. An interim analysis was done at around 200 patients, trial was not stopped, means drug efficacy at the interim was not great but not nil (to put it colloquially). Suggests the topline data from complete trial could look so-so. However, the important thing (which will get missed in the initial reaction) is if there are subgroups in which the drug performs very well. Hope is that in patients who started therapy early, the drug will be clearly effective (antivirals often need to be given early to work well). Yes this trial is using genuine GILD drug.
6. Another large and well designed trial should read out in May, this is the NIAD trial. Not much info has leaked on this one.
7. The trial that got attention today is GILD’s own trial. This one does not have a placebo arm, but GILD likely has good visibility into data and that’s no doubt why they are doing an open label trial.
8. GILD is ramping up manufacturing capacity, likely based on what they are seeing from their own trial. This drug is very hard to make, it takes a year from start to end. GILD had only enough for 140K patients and that is all being committed to clinical trials and compassionate use. They have managed to cut manufacturing time to six months, by end 2020 they hope to have enough drug for 1MM patients.
9. And it is an IV drug, as mentioned before.
Basically, looks to me like this drug has a reasonable chance of being effective in at least a subcategory of patients, and it will be in short supply, so it will (should) be limited to those patients who fit the profile for efficacy.
It is unlikely to be a huge moneymaker for GILD. They can’t set a monster price for it (not in this time and political climate), 1MM commercial courses x $10K is $10BN, and frankly I’m not sure they can/will charge that much. Might well be only a few $BN revenue. Which is not a game changer for GILD, but there are big political and
PR benefits too.
I bought GILD in portfolios in January for this drug (I like the stock for other things too), have not been paying super close attention to the rumours/tea leaves for the last couple months, but looks like it is time to start watching closely.