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EndoLogic Announces FDA Accepts Cardiac Safety Trial for Renzapride in Patients with Gastroparesis

May 15, 2018

Study demonstrates no evidence of QTc prolongation

EndoLogic remains on plan to initiate 12-week renzapride Phase 2 trial pending collaboration with a development partner

CLIFTON, N.J., May 15, 2018 (GLOBE NEWSWIRE) -- EndoLogic announced that the FDA accepted the cardiac safety trial for renzapride in patients with gastroparesis. That study demonstrated no evidence of QTc prolongation in the EKG findings. The U.S. Food and Drug Administration (FDA) views this study as sufficient to characterize renzapride’s QTc prolongation potential at both therapeutic (4 mg per day) and supra-therapeutic (20 mg per day) doses of the compound in patients with gastroparesis.

“Renzapride is a member of the same 5-HT4 agonist class as the once highly efficacious and commercially-successful cisapride (Propulsid®; more than $1 billion in annual sales),” said Kamal Dutta, M.D. co-founder and president of EndoLogic. “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.”

Renzapride, a 5-HT4 agonist and 5-HT3 antagonist, has been studied in more than 5,000 patients and was also well tolerated and showed no evidence of cardiotoxicity. A pilot Phase 2 study in patients with diabetic gastroparesis showed significant improvement in gastric emptying in a dose-dependent manner. In vivo studies have demonstrated that renzapride, with its 5-HT4 agonist activity has similar prokinetic activity as cisapride and, with its 5-HT3 antagonist activity, has eight times more antiemetic activity than cisapride. The company plans to conduct the Phase 2 study to identify the best dose to treat gastroparesis for the second pivotal trial.

“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,” said Zamir S. Brelvi M.D., Ph.D., co-founder and chief executive officer of EndoLogic. “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.”

Gastroparesis is a common condition affecting more than 20 million people in the U.S. including five million diabetics. Currently, treatment options are limited with only one drug, metoclopramide (brand name Reglan®), a four times daily oral dopamine D2 receptor antagonist, approved for the treatment of gastroparesis; however, treatment with metoclopramide for more than 12 weeks should be avoided due to the risk of tardive dyskinesia. Renzapride, a twice-daily oral medication, could be a promising and safe option for patients with gastroparesis. Being a prokinetic agent, it also has potential benefit in other indications such as proton pump inhibitor-refractory gastroesophageal reflux disease (GERD) and functional dyspepsia. Both of these conditions combined affect 50 million patients in the U.S.

About EndoLogic

The mission of EndoLogic LLC is to design, develop, and market new products to treat gastrointestinal diseases and address unmet needs. The company is developing renzapride, a 5HT-4 agonist and 5HT3 antagonist, for the treatment of gastroparesis, a poorly-met medical need and for other gastrointestinal indications. The company’s founders are Dr. Zamir S. Brelvi, a U.S. trained gastroenterologist and academic researcher with a vast experience in endoscopic procedures and device development, and Dr. Kamal Dutta. Dr. Dutta, a pelvic surgeon, who has more than 30 years of experience in research and development of pharmaceutical products and medical devices.

Corporate contact:Zamir S. Brelvi M.D., Ph.D.Chief Executive Officer zbrelvi@endologicusa.com

Investor/media contact:Robert Flamm, Ph.D.Senior vice presidentThe Ruth GroupP: 646-536-7017 rflamm@theruthgroup.com

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