This is a quote from Taylor Collison's report from their analysis of Phase IIa (back in 2009):
"We understand that while Biota has examined effects of BTA798 on CYP3A4 in vitro, there is further work to be done to completely rule out induction of this protein by BTA798 in vivo via reproductive toxicology studies."
As for monitoring it in the clinic. Phase IIa were male subjects only. And who knows out of the 93 in Phase IIb were females taking contraceptive pills.
I should also point out, that the FDA report on Pleconaril, the contraceptive drug interaction problem seemed to relate to a 6 week prophylaxis study. Here is the quote:
"Six-week exposure to pleconaril at 400 mg QD or BID in a prophylaxis study had a similar safety profile to that of the proposed treatment regimen of 400 mg TID for 5 days, with the exception of an increased incidence of menstrual disorders (e.g., breakthrough bleeding/spotting) in women taking oral contraceptives."
Anyhoo, absolute super worst case scenario, if all capsid binders do mess with contraceptive strategies, there is still a large cohort (children, males, females not on contraception) with an unmet medical need.
But it would be nice if someone found out from the company....
BTA Price at posting:
$1.02 Sentiment: Buy Disclosure: Held
