Tranzyme has announced its most advanced drug in development has failed to meet the main goal of a mid-stage trial.
The experimental oral ghrelin agonist drug was being developed to reduce symptoms of gastroparesis, a type of paralysis of the stomach.
The main aim of the study was to reduce the four key symptoms of the condition: nausea, early satiety, bloating and upper abdominal pan.
In the study, diabetic patients were given either a single daily does of Transyme’s drug in 10mg and 20mg doses or given a placebo for 12 weeks.
Neither the 10mg dose group or the 20mg dose group reached statistical significance versus placebo, although both doses were well-tolerated.
"We are understandably disappointed with the results of this trial; however, our second Phase 2b trial known as DIGEST is ongoing.
"In DIGEST we are evaluating a 10mg dose of TZP-102 administered three times daily before meals, rather than once daily as in the trial just completed. We anticipate announcing top line results for DIGEST in the first half of 2013," said Vipin K. Garg, PhD, president and chief executive officer of Tranzyme.
As a result of these latest oral ghrelin agonist drug results, Tranzyme’s shares floating on Nasdaq fell from $4 to $1 on Thursday.
This second set-back comes after Tranzyme’s experimental drug to improve gastrointestinal recovery after surgery failed to meet the main goals of a second late-stage trial in May.