RE:RE:RE:How LTE suddenly became a cause of failureLTEs are NOT "liver damage."
https://www.healthline.com/health/transaminitis
MasterAlgae wrote: 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 not something that is ingestable for any length of time. Hence the slide, and lack of pharma interest.
The results are indicating that there is a very limited potential market for H2S and getting a cash flow from a drug depends on its widespread regular usage - Oten is not a drug it can not be tolerated for very long - thus limited potential cash flow, as in not enough to cover development costs, hence no pharma stepping up...
MrMugsy wrote: 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 need more information from ATE and based on comments from others who have inquired ... could be weeks away.
IMO
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Edou111 wrote:
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