RE:PH2 Liver transient elevatisame as you guessed it nasaids... For all the flack management got for not "juicing" the share price from overhyping they should be respected for their message still remaining intact.
They always said it wasn't about being superior pain relief, we just had to not be inferior. The same should be said for aminotransferases, we shouldn't HAVE to be lower than the rest of NSAID class we should just be consistent which we are based on stats available. The entire pitch has been superior GI safety. Everything has been in place and remains in place if you look at the wording of the press release.
This is a pause from Health Canada, not a halt from the FDA. I'm still seeing this through to the end as other liver functions were normal.
P.S. I'm still most excited for ATB-352, always have been, with another third and fourth bullet in the chamber to be bullish about :)
WalkOverTheStrt wrote: https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.14641
3.7 Liver-related effects
Blood levels of liver enzymes (including alanine transaminase and aspartate transaminase) were measured on Days 7 and 14 of treatment and at 2 weeks post-treatment (Day 28). Over the 14-day treatment period, clinically insignificant, treatment-related transient elevations in liver transaminases were observed in 7% of subjects receiving ATB-346 and 7% of subjects receiving naproxen.
One subject receiving ATB-346 had clinically significant, treatment-related, transient transaminase elevations during this period. At the 2-week post-treatment assessment, 5.4% of the ATB-346-treated subjects had clinically significant, treatment-related, transient transaminase elevations that had resolved or were resolving. Cumulative data from the three clinical trials in which ATB-346 has been administered at 250 mg once daily for 10–14 days reveal a 4.7% overall incidence of clinically significant increases in liver transaminases. This is comparable to what has been observed with the use of NSAIDs such as diclofenac, naproxen, and piroxicam (~4%) and well below that observed with acetaminophen (39%; National Institute of Health, n.d.). One naproxen-treated subject had clinically significant elevations of alkaline phosphatase and total bilirubin at the end of treatment (Day 14).