Media

EndoLogic Announces Feedback from Positive FDA Meeting for Renzapride in Diabetic Gastroparesis

FDA pre-IND meeting minutes describe steps required for new drug application (NDA) submission No additional toxicology studies required to initiate Phase 2 trial EndoLogic will move forward with a 12-week renzapride Phase 2 trial that could be considered one of two pivotal studies

CLIFTON, N.J., Aug. 09, 2017 (GLOBE NEWSWIRE) -- EndoLogic announced that it has received the minutes from the U.S. Food and Drug Administration (FDA) of a pre-IND meeting held to discuss the requirements for an IND submission to initiate a proposed Phase 2 trial and later NDA submission of the prokinetic agent, renzapride, for use in patients with diabetic gastroparesis. The meeting was held on July 25, 2017. The minutes indicate that:
  • No additional toxicology studies would be required to proceed with the Phase 2 trial; all previous toxicology work conducted by Alizyme, the prior sponsor of renzapride, will be accepted;
  • The chemistry, manufacturing and controls approach to be executed by Patheon, Inc., to manufacture the renzapride active pharmaceutical ingredient (API) and finished renzapride capsule, is acceptable to the FDA for submission of the IND;
  • The Phase 2 trial will be extended to 12 weeks rather than the four weeks as originally proposed; this revision in the study protocol would enable the trial, if successful, to be considered as one of two pivotal trials essential to submit an NDA;
  • A thorough QT study, successfully completed and previously submitted to the FDA by Alizyme, will be reviewed by the FDA for adequacy; that study demonstrated no significant QT prolongation at renzapride doses from 4 mg per day (the maximum proposed dose for the Phase 2 trial) to 20 mg per day (a supra-therapeutic dose).

“We had a very positive and constructive meeting with the FDA and we are now finalizing the design of the Phase 2 study,” said Zamir S. Brelvi M.D., Ph.D., co-founder and chief executive officer of EndoLogic. “The meeting outcome clarifies our development path, and both lowers the potential cost of development and potentially shortens our timeline toward an NDA submission compared to our original expectations. We are currently seeking to raise $15 million that will be employed to complete the manufacturing of renzapride and fund the Phase 2 trial.”

Kamal Dutta, M.D. co-founder and president of EndoLogic added, “We anticipate submitting the IND in the fourth quarter of 2017, with dosing of the first patient expected in the second quarter of 2018. Now that the development path is defined, we are looking forward to fully developing renzapride and ultimately bringing it to patients who need it.”

Renzapride, a 5-HT4 agonist and 5HT-3 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 second pivotal 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 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.

EndoLogic Announces Scheduling of pre-IND Meeting with FDA to Discuss Renzapride in Diabetic Gastroparesis

Meeting scheduled on July 25, 2017, will address proposed renzapride Phase 2 trial and acceptability of toxicity and safety evaluations that had been previously submitted to the FDA

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.

EndoLogic Acquires Renzapride from Alizyme, plc

Clinical-stage asset to be developed for gastroparesis, a poorly-met medical need

CLIFTON, N.J., Jan. 03, 2017 (GLOBE NEWSWIRE) -- 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
zbrelvi@endologicusa.com

Investor contact:
Robert Flamm, Ph.D.
Senior vice president
The Ruth Group
P: 646-536-7017
rflamm@theruthgroup.com

Renzapride (ATL-1251)


Renzapride is best suited as a treatment of Diabetic Gastroparesis, a condition with a significant unmet treatment options. In the numerous trials that have been done using Renzapride more than 5000 patients have been treated with Renzapride. An extensive cardiac safety evaluation under the FDA mandated Thorough QT trial has shown that Renzapride does not have any cardiac safety issues.

Our Company


EndoLogic is a newcomer in the pharmaceutical and medical device marketplace, but the idea of its creation was conceived a decade ago by its founders, Dr. Zamir S. Brelvi and Dr. Kamal Dutta. Dr. Dutta, a pelvic surgeon, brings more than 30 years clinical knowledge and business development. Dr. Brelvi received his PhD and MD from University of Medicine and Dentistry of New Jersey.