Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001

Phase 1 study in healthy volunteers lays groundwork for Ent001 evaluation in patients with inflammatory bowel disease and type 1 diabetes

MILAN--(BUSINESS WIRE)--Enthera Pharmaceuticals (“Enthera”), a biotech company developing first-in-class biologics for selected autoimmune conditions, today announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001. Ent001 is a monoclonal antibody (mAb) targeting the IGFBP3/TMEM219 pathway, which plays a critical role in both inflammatory bowel disease (IBD) and type 1 diabetes (T1D). Elevated levels of IGFBP3 bind to the TMEM219 receptor, causing apoptosis of both colonic stem cells in the gut and insulin-producing beta cells in the pancreas. Ent001 is designed to bind to TMEM219 and prevent cell death and the inflammation underlying these disease states. The trial in healthy volunteers will evaluate Ent001’s safety and tolerability and establish optimal dose levels for subsequent trials in patients with IBD and T1D, the target indications for the next stage of Ent001’s clinical development.

“The initiation of this trial is a major development milestone for Ent001 and transitions Enthera into a clinical stage company. The data we gather from this study will be instrumental to optimize the development of our lead candidate and enable future development in IBD and T1D,” said Aled Paton Williams, CEO of Enthera.

The Phase 1 trial will evaluate Ent001 in up to 30 healthy adult volunteers in a randomised, double-blind, placebo-controlled single ascending dose (SAD) study in the Netherlands. In addition to safety, the trial will assess Ent001’s pharmacokinetics, pharmacodynamics, and immunogenicity.

“This trial builds on our robust preclinical data that revealed a strong safety profile and demonstrated noteworthy results with Ent001’s unique mode of action in well-established animal disease models. We look forward to applying our unique understanding of the recently discovered IGFBP3/TMEM219 axis to establish Ent001’s potential as a first-in-class therapeutic with the ability to halt and reverse disease progression in IBD and T1D,” said Filippo Canducci, Chief Medical Officer of Enthera.

About Enthera Pharmaceuticals
Enthera Srl is a biotech company developing first-in-class biologics to transform the treatment paradigm for specific autoimmune conditions by preserving and re-establishing cell and organ function. The Company’s primary target indications are inflammatory bowel disease (IBD) and type 1 diabetes (T1D). Enthera’s pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in stem cell and beta cell apoptosis in the gut and pancreas, respectively.

Enthera is a private company headquartered in Milan, Italy, and founded in 2016 by Prof. Paolo Fiorina and Dr. Francesca D’Addio at BiovelocITA, Italy’s first biotech accelerator. The Company is backed by Sofinnova Partners, AbbVie INC, JDRF T1D Fund, Roche Finance LTD and a number of private investors. Enthera’s discovery engine and assets are protected by a broad portfolio of patents.

For further information: www.entherapharmaceuticals.com