BioVie Inc recently reported some unusual results from a clinical trial for Alzheimer’s.
They report some mildly encouraging cognitive improvements, but it’s only 3 months into the trial and there’s no placebo group, so it’s easy to imagine they’re just seeing a placebo effect (Annovis’ results show a clear placebo effect, presumably influencing the measurement rather than the actual health).
What interested me is this:
Reduces Horvath DNA Methylation SkinBlood Clock by 3.3 years after 3 months of treatment.
It’s not too hard to reduce the age on an epigenetic clock, and the clocks likely overstate the benefits of interventions. But I’m pretty sure they measure some sort of benefit. This is the biggest change that I know of.
BioVie also reported mild improvements in TNF-alpha (inflammation), brain glutathione, and blood oxygen in the brain. Any one of these effects would seem unimportant by itself, but the variety of vaguely good results hints that the drug provides broad metabolic benefits.
BioVie’s drug is related to DHEA, a natural hormone that is maybe useful for treating diabetes. Alzheimer’s resembles and is correlated with diabetes (e.g. see here, here, and here).
Bredesen has used DHEA as part of his protocol for reversing Alzheimer’s (I don’t see any clear evidence about what role DHEA played, but I’m taking DHEA supplements just in case).
Yet DHEA is widely ignored because it’s
too cheap unpatented. So it’s not hard to imagine that a patented DHEA-like drug will be a valuable tool at getting the medical establishment to focus on treating Alzheimer’s as similar to diabetes.
To the extent that BioVie’s drug resembles DHEA, I expect it to have fewer adverse side effects than most proposed Alzheimer’s drugs.
Like type 2 diabetes, I see little hope for a single drug that fully prevents Alzheimer’s. I’m guessing that BioVie’s drug will provide somewhere between 1% and 10% of what’s needed to prevent Alzheimer’s from progressing. And as with type 2 diabetes, lifestyle choices will remain an important and difficult part of preventing Alzheimer’s.
I’ve bought a small amount of stock in BioVie. See pro and con opinions at Seeking Alpha.
BioVie seems to have had a modest short squeeze last week. Short sellers have been paying annualized rates of over 100% to borrow shares, which says they’re pretty confident.
Some of that is likely due to general evidence about the failure rates of Alzheimer’s drugs, and some lack of professionalism among other small companies that are working in this area. Or maybe an impression that the FDA is biased against small companies.
Short sellers are likely also betting that BioVie will need to sell shares to raise more cash soon. A typical drug startup in these circumstances would have already sold into last week’s rally. BioVie might just barely survive with no new funds until its next announcement of clinical results, but I’ll be surprised if they accept the risks involved.
I’ve been cautious about buying, because short sellers who pay those borrow rates tend to be right. But I think they’re only right about the short-term.
BioVie has some hope of selling this drug starting in mid-2024. That should be treated as a best-case scenario, not as a likely outcome.
P.S. – What about using other diabetes treatments for Alzheimer’s? From Deciphering the Roles of Metformin in Alzheimer’s Disease: A Snapshot:
metformin use contributes to a lower risk of developing AD and better cognitive performance … Current studies on the effects of metformin on AD and the underlying mechanisms remain limited and controversial. It is also necessary to take its adverse effects into consideration before regarding metformin as a candidate for AD prevention and early-stage treatment.