$VKTX - There was only 1 (as in ONE) discontinuation due to an AE in the induction phase of the Maintenance trial per the PR*. ONE, in an accelerated 2-week induction titration scheme‼ (I'm not talking about total DCs in induction, only the ones due to AEs.) For those of you good at math one out of ~161 treated in induction is less than 1%.
Discontinuations for other reasons (e.g., withdrew consent, lost to follow-up, protocol deviation) aren't reported, but the n's suggest they happened. There were 161 VK2735 subjects in the induction efficacy population and only 143 appear in the maintenance arms, so roughly 18 appear to have left during induction (I did the math).
➡I will repeat for clarity that only 1 (one) discontinued due to an adverse event out of 161 treated in induction. That is less than 1%. (
@ChillBanking please feel free to comment😉)
➡This was in what many thought was a really aggressive titration scheme that would be problematic (not me, and certainly not Viking).
➡On GI AEs during induction, the PR says they were "characterized as mild" and that the incidence "was low and declined over time." Despite "the accelerated 2-week titration schedule," rates were "similar to those reported in the prior Phase 2 study" (VENTURE), "which utilized 3-week titration steps."
*Note: Here is the direct quote from the press release I refer to: "One subject (1%) in the induction period discontinued VK2735 treatment due to an adverse event."