I believe ARYX afib [Phase 2b] data looks better than crme's
MRK obviously saw something it likes better in CRME's oral Vernakalant than ARYX's ATI-2042, as the latter compound remains unpartnered. What do you see in the data for ATI-2042 that you like better than oral Vernakalant? And does it relate to efficacy, safety, or both? Ghmm posted the Phase 2b results for oral Vernakalant here: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=30672478&txt2find=crme
I looked at both sets of data for a comparison. Both trials were randomized, double-blind, placebo controlled Phase 2b trials. CRME's trial was much bigger at 735 patients compared to just 72 patients in ARYX's Phase 2b. Both trials ran for 12 weeks, although ARYX had the additional 4-week "washout period."
In terms of efficacy for ATI-2042, the 400mg and 600mg BID doses attained statistical significance (p=0.015 and p=0.005, respectively) in reducing the "atrial fibrillation burden" from baseline by 54% and 75%, respectively. In terms of efficacy for oral Vernakalant, the 500mg BID dose significantly reduced the rate of atrial fibrillation relapse compared to placebo (p=0.0221). The median time to recurrence of atrial fibrillation was greater than 90 days for 500mg oral Vernakalant, compared to 27 days for placebo.
So, the p value is stronger for the ATI-2042 data but can you even make an apples-to-apples comparison between the data in these two trials? ARYX is citing percentages and referencing "atrial fibrillation burden" whereas CRME is referencing the number of days and median time to recurrence of atrial fibrillation. Is this more of an apples-to-oranges comparison?
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