IrishCanuck wrote: Well Stockhouse is turning out to be exactly what I expected it to be today lol This will be my only post today because I'm not getting into this toxic thread with trolls, but you're welcome to message me if you have further questions. This is how I would break down the press release today, which yes they were legally required to release, but not be apocalyptic in view. Antibe and countless companies have gone through this.
1) "Antibe Therapeutics... has placed its absorption, metabolism and excretion (“AME”) study of otenaproxesul on a required pause because a pre-specified safety threshold was exceeded." - The safety threshold is likely set based on
normal levels in healthy populations, not a control baseline to the patients themselves. The threshold will be set much lower than is even worrying to patients. More on that in a second, but it's possible patient transaminase levels are higher at baseline due to a variety of factors (obesity, high blood pressure etc...) before the drug was even taken.
2) "The AME study had enrolled a total of 42 subjects on either a 75 mg or 100 mg daily dose of otenaproxesul, of whom 35 had completed the 28-day drug administration period, with seven subjects having been administered the drug for 21 days. Three subjects in the 100 mg cohort, who had completed the full drug administration period, exhibited liver transaminase elevations exceeding five times the upper limit of normal, triggering the required pause."
- 3 of 42 patients is ~7% which is in line with Slide 38 of the presentation deck. This statement clearly indicates the patients had safe levels in their liver during the study and concerns arose in the time after the drug was no longer given.
- In slide 38 it says "During the treatment period, only 1 out of 318 patients administered otenaproxesul had clinically significant, temporary liver enzyme elevations (“LTEs”) — this is a known “class effect” of NSAIDs. At the post-treatment assessment, patients in the 250 mg, 200 mg and 150 mg treatment arms had LTE incidences of 12.9%, 7.2% and 9.8%, respectively - acetaminophen use, pre-existing liver conditions and concomitant statin use were associated with a majority of the LTE incidents; adjudication yields rates of 4.5%, 3.2% and 3.3%, respectively, suggesting a liver safety profile comparable to commonly prescribed NSAIDs.
3) "The AME study had enrolled a total of 42 subjects on either a 75 mg or 100 mg daily dose of otenaproxesul, of whom 35 had completed the 28-day drug administration period, with seven subjects having been administered the drug for 21 days. Three subjects in the 100 mg cohort, who had completed the full drug administration period, exhibited liver transaminase elevations exceeding five times the upper limit of normal, triggering the required pause."
- Back to my point #1, normal levels are: "According to the American College of Gastroenterology, the normal value for ALT in blood for people without risk factors for liver disease ranges from 29 to 33 international units per liter (IU/L) for males and 19 to 25 IU/L for females. This value can vary depending on the lab." This would make 5x the normal levels 165 and 125 for males and females respectively.
- One dose of naproxen taken leads to ALT units/Litre alone to 2000+. https://www.ncbi.nlm.nih.gov/books/NBK548159/ and Ibuprofen also gets you 2000+ https://www.ncbi.nlm.nih.gov/books/NBK547845/ and lots of other NSAIDS https://www.ncbi.nlm.nih.gov/books/NBK548614/
4) "Other indicators of liver function for these subjects were normal."
- I would interpret that Bilirubin and Alkaline Phosphatase levels are healthy. Other indications would be bad in a failing liver.
5) "The study incorporates an in-clinic post-administration observation period of 14 days, which is continuing."
- Like point #2, the levels could be caused by several other factors such as medications or people having a few drinks in the summer post-COVID they go to a barbecue and sneak a beer because one wont' hurt (and it doesn't hurt physically) but the synergistic effects of a drug and alcohol cause exponential increase of transaminase levels. You can't develop a drug that's not going to get processed in the liver so we expected this and Joe Stauffer said levels after Phase 2 are clinically manageable.
The rest of the statements are legal requirements and nothing out of the ordinary. I think it'll hurt today for sure but business is never friendly to science, the stock market is hardly going to be polite. Invest in what you know, so I'm not lettting these retail panic sells rattle me. Cheers.