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CLIFTON, N.J., Jan. 03, 2017 -- EndoLogic, a company focused on the development and commercialization of products that treat gastrointestinal diseases, has acquired the worldwide rights to the clinical-stage asset, renzapride, from Alizyme, plc. Renzapride has been in clinical development for use as a prokinetic agent for the gastrointestinal tract. EndoLogic plans on developing the compound for the treatment of gastroparesis.
Renzapride, a 5-HT4 agonist and 5HT-3 antagonist, has been studied in more than 5,000 patients including one Phase 3 trial for the treatment of constipation-dominant irritable bowel syndrome (IBS-C). Renzapride demonstrated a small but statistically significant benefit in the Phase 3 study in IBS-C, however, Alizyme decided to not continue to pursue development of the drug for this indication. The drug was 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 a Phase 2 study to identify the best dose to treat diabetic gastroparesis for Phase 3 testing.
Gastroparesis is a common condition affecting more than 20 million people in the U.S. including 5 million diabetics. Currently, only one drug, metoclopramide (brand name Reglan®) a dopamine D2 receptor antagonist, is approved for the treatment of gastroparesis. Unfortunately, patients are at risk for serious side effects some of which are permanent, such as tardive dyskinesia, hence limiting its use to no more than 12 weeks. It is also relatively inconvenient to administer, taken orally four times daily usually 30 minutes prior to a meal and at bedtime. Renzapride, a twice-daily oral medication, could be both a more convenient and safer alternative if successfully developed and approved by regulatory authorities. It also has potential benefit in other indications in which a prokinetic agent could be beneficial such as gastroesophageal reflux disease (GERD).
“We purchased renzapride from its original developer because we saw significant opportunity as a therapeutic to address the poorly-served therapeutic area of diabetic gastroparesis,” said Zamir S. Brelvi M.D., Ph.D., co-founder and chief executive officer of EndoLogic. “Although the compound demonstrated very promising activity in a Phase 2 pilot study in diabetic gastroparesis, the prior owner of the asset decided to develop the drug for what they viewed as a more significant market opportunity in IBS-C, another indication in which prokinetic compounds could be of value. Its promising activity in early studies in gastroparesis, its significant clinical experience, particularly its safety profile, and its potential in indications beyond gastroparesis suggest a relatively low-risk and high-reward asset. We are now looking for investors who are interested in working with the company to assist in developing renzapride and successfully launching the product.”
Drs. Brelvi and Kamal Dutta, Co-founder and President of EndoLogic, will be in San Francisco from Jan 9 to 13, 2017 to meet with members of the investment community. Please contact Robert Flamm from The Ruth Group if you wish to schedule a meeting.
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 have been submitted to the U.S. Food and Drug Administration for review. The company has acquired renzapride, a 5HT-4 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, 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, brings more than 30 years clinical knowledge and business development to the company.
Corporate contact: Zamir S. Brelvi M.D., Ph.D. Chief Executive Officer [email protected] Investor contact: Robert Flamm, Ph.D. Senior vice president The Ruth Group P: 646-536-7017 [email protected]
