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FDA accepts cardiac safety trial for gastroparesis drug
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The FDA has accepted a cardiac safety trial for renzapride, a 5-HT4 agonist and 5-HT3 antagonist for the treatment of patients with gastroparesis, according to the manufacturer, EndoLogic.
The company said the acceptance sets the table for a 12-week, phase 2 trial that it plans to initiate pending collaboration with a development partner, according to a press release.
“Renzapride is a member of the same 5-HT4 agonist class as the once highly efficacious and commercially-successful cisapride (Propulsid),” Kamal Dutta, MD, co-founder and president of EndoLogic, said in the press release. “However, renzapride is without the serious cardiac side effects, including deaths that emerged with cisapride. In addition, renzapride is an antiemetic due to its strong 5-HT3 antagonism. There is a need for a safe and well-tolerated treatment for gastroparesis. We are confident that renzapride could fill that void by demonstrating efficacy in treating patients’ symptoms such as severe abdominal pain, nausea, vomiting, bloating and early satiety.”
EndoLogic said the trial submitted to the FDA showed no evidence of QTc prolongation in the electrocardiogram. Additionally, researchers have studied renzapride in more than 5,000 patients and found it was well-tolerated and showed no evidence of cardiotoxicity, according to the press release.
A pilot phase 2 study also showed a significant improvement in gastric emptying in a dose-dependent manner. The next phase 2 trial will help identify the best dose for the treatment of gastroparesis, according to the press release.
“The FDA acceptance of our cardiac safety study confirms our own view that renzapride exhibits no cardiotoxicity and is thus a game changer for this drug,” Zamir S. Brelvi, MD, PhD, co-founder and CEO of EndoLogic said in the press release. “Renzapride’s cardiac safety and its dual action as a prokinetic and antiemetic with virtually no drug-drug interactions positions renzapride as 'best in class’ and a long-awaited treatment for gastroparesis. We are now fully ready to collaborate with a partner to move forward with our upcoming phase 2 trial.”
Disclosures: Dutta and Brelvi are employed by EndoLogic.