EndoLogic Announces Scheduling Of Pre-IND Meeting With FDA To Discuss Renzapride In Diabetic Gastroparesis
CLIFTON, N.J., May 03, 2017 (GLOBE NEWSWIRE) -- EndoLogic, a company focused on the development and commercialization of products that treat gastrointestinal diseases, announced that the FDA has scheduled a pre-IND meeting with EndoLogic to discuss the requirements for the proposed Phase 2 trial of the prokinetic agent, renzapride, in diabetic gastroparesis and the need for additional safety and toxicity clinical evaluations beyond what had been previously submitted by renzapride’s prior sponsor. The meeting will be on July 25, 2017.
“Renzapride is an asset that was successfully developed through one Phase 3 trial for irritable bowel syndrome by its previous owner,” said Zamir S. Brelvi M.D., Ph.D., co-founder and chief executive officer of EndoLogic. “We believe, based on a pilot study, the drug’s dual mechanism of action and significant clinical exposure in approximately 5,000 patients that it has significant potential to be a safe and effective treatment for patients with gastroparesis. We look forward to our meeting with the FDA to define a path forward for renzapride and initiating our Phase 2 trial as soon as we can following the meeting.”
Renzapride, a 5HT4 agonist and 5HT3 antagonist, has been studied in more than 5,000 patients including in one Phase 3 trial for the treatment of constipation-dominant irritable bowel syndrome (IBS-C). Renzapride demonstrated a statistically significant benefit in the Phase 3 study in IBS-C. The drug was also well tolerated and showed no evidence of cardiotoxicity. A pilot Phase 2 study in patients with diabetic gastroparesis showed that doses of 0.5 mg, 1.0 mg and 2.0 mg, once-daily, showed significant improvement in gastric emptying in a dose-dependent manner. The company plans to conduct the Phase 2 study to identify the best dose to treat diabetic gastroparesis for the Phase 3 trials.
Gastroparesis is a common condition affecting more than 20 million people in the U.S. including 5 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. Renzapride, a twice-daily oral medication, could be a promising option for patients with gastroparesis. It also has potential benefit in other indications that could benefit from a prokinetic agent such as 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. The company has developed a series of medical device products for the removal of colon polyps and foreign bodies. 510K applications are being prepared for submission to the U.S. Food and Drug Administration for review. The company has acquired renzapride, a 5HT4 agonist and 5HT3 antagonist, to develop it 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, 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 contact: Robert Flamm, Ph.D. Senior vice president The Ruth Group P: 646-536-7017 rflamm@theruthgroup.com