Antibe Therapeutics Inc(Pre-Merger) ATBPF

RE:RE:RE:RE:RE:RE:RE:Keep this in mind LONGs ...

[themagicbox]

I appeciate the discussion and the links. 

As a prescriber myself, general rule of thumb is to go low and slow especially for the elderly population and repeat blood work on routine bases (liver issues usually Q3 months); this rule also applies for off label use. However, it will be based on balance of risk, benefit, and patient desired outcomes. 

To your point, DILI due to hepatocellular (cytotoxic) injury with ALT x3 > normal limits is associated with a mortality rate in this setting can be as high as 14 percent. Sounds scary but clinically not an issue. With Tyelenol that number is 10 times the upper limit of normal (uptodate Drug-induced liver injury, 2021). Tylenol would obviously never be approved today but the point is that its the drug of choice for pain management in the elderly and preganat women. Boggles the mind sometimes, espcially given that acute liver failure due to acetaminophen requiring hemodialysis is not uncommon

w.r.t. minimum dose an efficacy, at the 21:11 mark (https://www.youtube.com/watch?v=w_3heP7ol0A) at 75mg of otena there is a  > x3 fold reduction in TXB2 activity in 24 hours, indirectly hinting analgesic efficacy. I think there is a point of diminishing returns on a dosing. I suspect thats why they have said in the past they will go down to 25mg, espcially given the long half life. Since the oxidative stress is both dose and time dependent, the lower dosage should be able to move needle. To what degree, we will find out in the upcoming studies. Or they already have that info from their PK/PD studies they just completed. So I am very confident they will find minimum effective dose without an issue. 

Great point on the patents for the chronic indication. I did not know this, but should the minimum effective dose be 25mg or under, I highly suspect the off label use will skyrocket, even as prescription drug. The cherry on top will be getting the FDA approval for that.