PHILADELPHIA, August 25, 2021 (Newswire.com) - Enterin, Inc., a privately held, Philadelphia-based, clinical-stage biopharmaceutical company pioneering novel treatments for neurodegenerative and metabolic diseases, announces that Hilde Williams has joined the organization as a Senior Regulatory Advisor. In this capacity, she will oversee and direct all regulatory activities for Enterin's clinical development programs. Ms. Williams is an experienced regulatory strategist with over 30 years in biotech/pharma.
Ms. Williams has successfully led regulatory strategy from Pre-IND through NDA for neurologic, psychiatric, and other development programs and has served in executive leadership team positions. Most notably, Ms. Williams served as Sr. Vice President Regulatory Affairs and Development for Acadia Pharmaceuticals where she oversaw the largest-ever international Phase 3 clinical trial in Parkinson's disease psychosis, including a successful pivotal study that met all study endpoints. Ms. Williams successfully garnered FDA agreement for an NDA submission based on a single Phase 3 study, gained strategic Breakthrough Designation (a first for the Psychiatry Division) and secured Priority Review leading to the only approved label for the treatment of Parkinson's disease psychosis. Additionally, Ms. Williams has provided leadership on regulatory and development activities associated with the launch and conduct of multiple other development programs for CNS, psychiatric and other indications.
"We are extremely excited to have Hilde lead Regulatory Affairs at Enterin. Her extensive hands-on experience in the most difficult regulatory aspects of neurology and psychiatry and her exceptional leadership in the only FDA-approved drug for the treatment of Parkinson's disease psychosis to date will be of great value to Enterin," said Dr. Denise Barbut, Enterin's co-founder and CMO.
"I am excited to serve as Senior Regulatory Advisor for Enterin and oversee regulatory strategy and operations for the company's development programs," said Ms. Williams. "I believe Enterin's novel approach towards neurodegenerative diseases is truly groundbreaking, and I am looking forward to advancing the company's regulatory and development strategies."
About Enterin Inc.
Enterin Inc. is the first company to develop novel compounds that repair the dysfunctional gut-brain axis in patients with neurodegenerative diseases. Enterin Inc. is pioneering the medical community's understanding of the link between infections, dysfunction of the enteric nervous system (ENS) of the gut and the early onset and chronic progression of neurodegenerative disease. The lead compound, ENT-01, displaces membrane-bound alpha-synuclein (αS) aggregates from nerve cells in the ENS and improves neural signaling between the gut and the brain in preclinical models of Parkinson's disease. Enterin Inc. is now progressing ENT-01 through Phase 2 clinical trials in an attempt to reverse the neurologic symptoms of Parkinson's disease. The second compound, ENT-03, increases insulin sensitivity by acting at the level of the brain and rapidly normalizes blood sugar in diabetic mice. ENT-03 is being developed for the treatment of diabetes, obesity and Alzheimer's disease. Studies in humans will begin in H1 2022.
For more information, please visit www.enterininc.com.
Source: Enterin Inc.