Antibe Therapeutics Inc(Pre-Merger) ATBPF

RE:RE:silly question?

[HarveyTwoface]

A lot of focus on GI safety from ATE, but what about things they need to sort out that might cause possible delays (and a lot of extra costs) before or during phase III studies...?


FDA, March 2020:
Safety Testing of Drug Metabolites Guidance for Industry

"This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. Drug metabolites may need to be determined in nonclinical studies when they are disproportionate drug metabolites, that is, metabolites identified only in humans or present at higher plasma concentrations in humans than in any of the animal species used during standard nonclinical toxicology testing."

https://www.fda.gov/media/72279/download


Antibe Therapeutics, Feb 2019:
"It is likely that there is rapid formation of at least one active metabolite of ATB346. The blood concentrations of naproxen generated from ATB346 are not sufficient to account for the COX inhibition that is observed (with respect to both potency and duration of inhibition)."

"Analysis of ATB346 metabolism in humans has revealed the presence of several naproxenlike structures with possible inhibitory effects on COX. These ATB346 metabolites are presently being characterized to establish a better understanding of the mechanisms contributing to the substantial increase in potency and duration of activity of the drug."

Page 7, https://antibethera.com/wp-content/uploads/2019/08/Wallace-2019-Br-J-Pharmacol-ATB-346-Phase-2B-GI-Safety.pdf