Expanded Trial for Endometriosis Initiated

Enteris BioPharma Announces Completion of Recruitment in Expanded Phase 2a Clinical Trial of Ovarest® (oral leuprolide tablet) for Endometriosis

Additional treatment arm to examine improved formulation and higher dose

BOONTON, N.J., April 30, 2018 /PRNewswire/Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary oral drug delivery technologies, announced today that recruitment and the initial dosing of all subjects has been completed in an additional treatment arm of the Phase 2a clinical trial of Ovarest®, an oral formulation of leuprolide, for the treatment of endometriosis. The trial expansion follows the successful completion of the study’s three initial treatment arms and is intended to explore an improved formulation and higher dose of Ovarest in a single treatment arm comprised of 12 normal healthy volunteers.

“Expansion of the Phase 2a study is a key advancement in the development of Ovarest as it provides an opportunity to explore the potential efficacy of a higher dose and improved formulation of our oral tablet product in the treatment of endometriosis,” said Joel Tune, Chief Executive Officer and Executive Chairman of Enteris BioPharma.

“With all 12 subjects in the additional treatment arm having successfully received their initial dose, we now look forward to reporting data early in the third quarter and, following that, initiating the anticipated Phase 2b study. Endometriosis remains a severely underserved market due to challenges with the currently-approved, injectable treatments. Ovarest has the potential to meet this critical patient need with this proven and well understood drug. It has the potential to capture a significant portion of the endometriosis market.”

Previously, data from the Phase 2a study indicated that Ovarest significantly suppressed estradiol (E2), demonstrating a measurable pharmacodynamic effect that is tightly correlated with efficacy in endometriosis. Ovarest utilizes a novel formulation technology called Peptelligence®, Enteris’ proprietary platform that enables oral delivery of molecules that are typically injected, including peptides and BCS class II, III and IV small molecules.

About Enteris BioPharma

Enteris BioPharma, Inc. is a privately held, New Jersey-based biotechnology company offering innovative formulation solutions built around its proprietary drug delivery technologies. The Company’s proprietary oral peptide delivery technology – Peptelligence® – has been the subject of numerous feasibility studies and active development programs, several of which are in late stage clinical development. Additionally, Enteris BioPharma is advancing an internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities for which there is no oral delivery option.

Enteris BioPharma’s most advanced internal product candidate, Ovarest® (oral leuprolide tablet), is an oral peptide being developed for the treatment of endometriosis. Tobrate® (oral tobramycin tablet) is also being developed by Enteris BioPharma for the treatment of uncomplicated urinary tract infection (uUTI). A third internal compound, octreotide, will be entering preclinical development in 2018. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit https://www.enterisbiopharma.com.

  For Enteris BioPharma: Enteris Media Relations:
Brian Zietsman, President & CFO
Jason Rando
Tiberend Strategic Advisors, Inc.