GREY:ATBPF - Post by User
Comment by
Inthepezon Oct 21, 2021 11:59am
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Post# 34032972
RE:How LTE suddenly became a cause of failure
RE:How LTE suddenly became a cause of failureHere’s a crazy idea, send that message to IR
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