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The company will use the results from this study to inform dose
selection for a larger Phase IIb trial planned to commence early next
year. The company is at the same time advancing the reformulation of
DG031, which also targets the leukotriene pathway for the prevention of
heart attack. The company has completed an accelerated 3-month
stability study with its lead reformulation and expects to complete
pharmacokinetic analysis of its bioequivalence study before the end of
this year.
-- DG041 for arterial thrombosis. In the past quarter deCODE has
successfully completed additional clinical studies with DG041, its
novel, first in class antagonist of the EP3 receptor for prostaglandins
E2. deCODE is developing DG041 as a next-generation oral anti-platelet
therapy -- a mechanism specific means of preventing arterial thrombosis
without increasing bleeding time. Clinical studies completed early this
summer demonstrated that in a concentration-dependent manner DG041
dramatically inhibits platelet activation mediated through vasodilator-
stimulated phosphoprotein (VASP) as well as platelet aggregation.
Moreover, the desired effect on VASP -- a biomarker useful for gauging
platelet activation -- appears to be achievable at doses lower than
previously anticipated. The company has built on those results in the
past quarter with the completion of two drug-drug interaction studies
that showed DG041 to have a very satisfactory DDI profile. Moreover, in
a double-blind, placebo-controlled clinical study, DG041 was shown to
have the desired effect on VASP, and in a significant and
concentration-dependent manner, irrespective of whether subjects were
also receiving aspirin. This supports DG041's development as a compoun
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