Biotech Values

[DewDiligence]

ABT Reports Positive Phase-3 Psoriasis Data for Briakinumab (a/k/a ABT-874)

http://finance.yahoo.com/news/Abbott-Reports-Psoriasis-prnews-1127459263.html?x=0&.v=2

In two of the four phase-3 studies reported in the above PR, Briakinumab was compared to Enbrel and was found to be statsig better at 12 weeks on the co-primary endpoints of PASI 75 and PGA 0/1. These two studies (called M10-114 and M10-315) were clones, so I’ve combined their results in the table below.

 
 Endpoint    Briakinumab  Enbrel  Placebo 
 PASI 75*       81%       48%      7% 
 PGA 0/1‡       72%       35%      4% 

* Psoriasis Area and Severity Index showing >=75% clearance.
‡Physician's Global Assessment of clear or normal.

ABT recently submitted a BLA and European MAA for Briakinumab, which targets the IL-12/23 pathways. If approved, Briakinumab will be a direct competitor of JNJ’s Stelara, which was approved in late 2009 (#msg-41895282) and showed superiority to Enbrel in psoriasis (#msg-45763880). Stelara is dosed every three months while Briakinumab is dosed monthly.