Antibe Therapeutics Inc(Pre-Merger) T.ATE

How LTE suddenly became a cause of failure

[Edou111]

Below is the 2020, June 1st PR.  I wish Antibe can explain how we went from a manageable issue to a total failure at lower doses and with less patients. I posted months ago that the LTE issue could explain the sustained decline in the SP and lots of the folk here accused me of bashing.  Wish the company could offer us an explanation.  Unless there is none and they just knew it...

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Only 1 out of 318 patients administered ATB-346 had clinically significant, temporary liver transaminase elevations (LTEs) during the 14-day treatment period. At the post-treatment assessment (day 24), patients in the 250 mg, 200 mg and 150 mg treatment arms had clinically significant, temporary LTE incidences of 12.1%, 8.0% and 8.2%, respectively. It is standard for pain trials to allow the use of other medications, commonly acetaminophen. Acetaminophen use, especially in the post-treatment assessment period, pre-existing liver conditions and concomitant statin use were associated with a majority of the LTE incidents. Accounting for these factors yields clinically significant, temporary LTE incidence rates of 4.5%, 3.2% and 3.3%, respectively, suggesting a liver safety profile for ATB-346 comparable to commonly prescribed NSAIDs and well below that observed with acetaminophen

[StockingUp21]

They didn't know it. They sell millions of dollars that day for other reasons  

[Inthepez]

Here’s a crazy idea, send that message to IR 

[MrMugsy]

I thought the decline was related to not having a lowest effective dose which meant they were a ways off from knowing - further drawn-out studies. The difference in LTE might come from short term use vs. long term use ... seemingly at any dosing for long term.  Therefore the pivot to acute makes sense while they attempt to solve the long term liver problem (confusing the liver ?). Yes - we

[MasterAlgae]

I think the decline is due to 12.1%, 8.0% and 8.2% of patients having clinical significent liver damage is too high for a drug to be marketable. It is only temporary damage if the patients stop taking the drug - then the liver damage is repaired. The liver is one organ that has an amazing ability to repair itself if the damage is not too bad. Even back then the signs were on the wall that H2S is

[Edou111]

If this can't be tolerated on a long period of time, why are we talking H2S for IBD ???

[MasterAlgae]

Excellent question. It demonstrates that there is no plan B - this is a one-trick-pony company, unless you want to count the dental tools and putty - which actually has revenue... What do you think the AME study will show when they do it for IBS? Any guesses?

[mstrmnd]

Misinformation spreading so let me out this right away.  ATB-429 parent moeity is Mesalamine.  ATB-346 (Otenaproxesul) parent is Naproxen.   In last AME with 42 participants, 3/42 expected with LTE, when 5/42 observed with parent Naproxen.   All claims about long-term intolerability of ATB-429 for IBD are false.  Lots of evidence to show Mesalamine is

[TriumphSpitSix]

LTEs are NOT "liver damage." https://www.healthline.com/health/transaminitis

[MasterAlgae]

You don't want elevated liver enzimes, Health Canada doesn't want LTE drugs out there either or they would not have shut down the continued use of Oten. That is quite obvious. "Elevated liver enzymes often indicate inflammation or damage to cells in the liver. Inflamed or injured liver cells leak higher than normal amounts of certain chemicals, including liver enzymes, into the

[MrMugsy]

I absolutely understand what you are saying about confirmation bias and people do need to keep it  in check.  That's true. But ... I look at the chronic pain dilemma a little differently than OTENA being done or being shutdown ... it's evolving. We are presently waiting for the company to  come up with as a regimen to keep the liver enzymes in check while also ensuring

[Layth1990]

This managment is rigged and all this sell pressure prior to AME is definitly insiders and they knew it. i don't think ATE will rise unless we have a new leader.