AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA

Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday (May 21) presented the results of two pivotal Phase III studies of naloxegol showing the 25mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies for the treatment of opioid-induced constipation (OIC), at the Digestive Disease Week (DDW) meeting in Orlando, Florida, USA.

The Phase III studies, KODIAC-04 and -05, were 12-week, multicenter, randomized, double blind, placebo-controlled pivotal trials that evaluated 12.5mg and 25mg doses of naloxegol, administered once-daily. The primary endpoint in both trials was percentage of OIC responders, versus placebo, over 12 weeks of treatment. The secondary endpoints included the 12-week response rate in a laxative inadequate response population, the median time to first spontaneous bowel movement (SBM) and the number of days per-week with at least one bowel movement.

Naloxegol is part of the exclusive worldwide license agreement announced in 2009, between AstraZeneca and USA-based Nektar Therapeutics (Nasdaq: NKTR), worth a potential $1 billion to the latter firm (The Pharma Letter September 22, 2009. Naloxegol was developed using Nektar's oral small molecule polymer conjugate technology. Plans for naloxegol will be finalized over the coming months, incorporating the outcome of ongoing discussions with health authorities in the USA, European Union and Canada.