The primary endpoint was an increase in what’s called six-minute walk distance (6MWD), which as the name makes pretty clear, is the distance a patient can walk within a six-minute period. It was measure from baseline, so the patients established a baseline at the beginning of the trial, and Reata will compare this baseline to the post dosing period 6WMD figure. We don’t have too much detail, even with the interim data announcement, but here’s what we know: that the patients in the treatment arm registered an improved 6MWD at 16 weeks, and as per the latest data, a similar increase at 32 weeks. Also tolerability was pretty good, with no real adverse events outside of what’s expected reported across the trial’s population.
The bottom line on this release is that it looks as though there is some level of efficacy, but exactly how much remains unclear. There have historically been some safety concerns with this type of treatment in other indications (a kidney disease trial discontinued in October 2012 after patients in the trial registered a higher rate of heart failure, hospitalizations, and death) but this – as yet – looks to not be too much of an issue.
The key timeframes to watch are September and December 2016. If Reata Pharmaceuticals Inc (NASDAQ:RETA) can put out data that supports its efficacy hypothesis at these dates, and there arise no significant AEs (at least, none that occur at a rate that would warrant discontinuation) then we should see some upside come completion.
Note: This article is written by Mark Collins and originally published at Market Exclusive.