AGI-010 is in clinical development for the treatment of Gastro-Esophageal Reflux Disease (GERD), particularly as experienced at night as 'Nocturnal Acid Breakthrough' (NAB)
AGI-010 is a delayed/controlled release formulation of the proton pump inhibitor drug ("PPI"), omeprazole which is being developed by AGI for the treatment of Gastro-Esophageal Reflux Disease ("GERD"), and in particular for the treatment of Nocturnal Acid Breakthrough ("NAB"), a poorly controlled aspect of GERD.
GERD is the most common of the major target GI disorders and it is estimated that its prevalence in the general population ranges from 20 to 40 per cent Proton pump inhibitors are commonly used drugs in the treatment of GERD and are one of the largest selling drug classes with global annual sales of US$21 billion. One of the most commonly prescribed PPI drugs is omeprazole, which was reported to have a 29 per cent share of the PPI market in 2003.
NAB is estimated to occur in more than 70 per cent of h.pylori-negative and in up to 50 per cent of h.pylori-positive GERD patients on PPI therapy. Modification of the dosage regime of existing PPIs has only had limited success in controlling the symptoms of NAB despite improving acid suppression. AGI believes that currently available PPI drugs do not adequately address the problem of NAB, which is a prevalent aspect of GERD, and that there are therefore market opportunities for improved PPI formulations.
AGI has developed CHRONAB, an approach to the formulation of PPIs to specifically address NAB. AGI's lead CHRONAB formulation is AGI-010, a delayed/controlled release formulation of omeprazole, which is designed to be taken once-daily at night-time and to release the drug over a 6-8 hour period to improve acid-suppression in the night-time hours.
An oral delayed release/controlled release formulation of AGI-010 with the desired in vitro characteristics has been developed and a combined human pharmacokinetics and pharmacodynamics study is ongoing.
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