Enteris BioPharma Announces Positive Results from Phase 2a Clinical Trial of Ovarest® (oral leuprolide tablet) for Endometriosis

Wednesday, January 3, 2018 Drug News
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Ovarest® Demonstrates Significant Suppression of Estradiol, Demonstrating Proof-of-Concept of Ovarest® Tablet for Treating Endometriosis

BOONTON, N.J., Jan. 3, 2018 /PRNewswire/ -- Enteris BioPharma, Inc., a biotechnology company developing innovative

drug products built around its proprietary delivery technologies, announced today positive results from the Phase 2a clinical trial of Ovarest®, an oral formulation of leuprolide, for the treatment of endometriosis. Data from the study indicated that Ovarest enabled significant suppression of estradiol (E2), demonstrating a measurable pharmacodynamic effect that is tightly correlated with efficacy in endometriosis.  Ovarest was developed utilizing Enteris' proprietary Peptelligence® platform, a novel formulation technology that enables oral delivery of molecules that are typically injected, including peptides and BCS class II, III and IV small molecules.

"The positive results from the Phase 2a clinical trial of Ovarest are a significant advancement towards Enteris' goal of developing the first-ever oral leuprolide tablet for the treatment of endometriosis," said Joel Tune, Chief Executive Officer and Executive Chairman of Enteris BioPharma.  "We look forward to advancing the Ovarest program into a Phase 2b trial, now that proof-of-concept has been established in our Phase 2a study.  It is our expectation that the Phase 2b trial planned for later this year will satisfy the requirements to make Ovarest a Phase 3-ready asset. We also intend to begin development of additional indications for oral leuprolide including uterine fibroid tumors and prostate cancer. Multiple other potential indications, such as use in in vitro fertilization (IVF) protocols and central precocious puberty, can be envisioned which may contribute to further significant commercial success."

Mr. Tune continued, "The ongoing progress of Ovarest provides important additional validation of our internal pipeline and our Peptelligence platform, which has successfully enabled the oral delivery of peptides and small molecules in multiple clinical settings. To enable us to accelerate the development and monetization of our internal pipeline, including Ovarest, Tobrate and Octreotide, as well as other potential pre-clinical opportunities, we are very pleased to announce that Enteris has engaged Torreya Partners to identify sources of growth equity and strategic partnerships.  We are excited to work with the seasoned and successful team at Torreya as we embark on what we hope will be a transformational 2018 for Enteris."

"The oral delivery of peptides is considered a 'Holy Grail' within the pharmaceutical industry given the numerous benefits that such drugs could offer across the entire healthcare continuum," said Tim Opler of Torreya Partners. "Based on our deep knowledge and experience, we believe that Enteris is at the forefront of a very large market opportunity. We look forward to working with Enteris to leverage the multiple value drivers that its Peptelligence platform and high-value internal and external development programs represent."

Since its founding in 2013, Enteris BioPharma has advanced multiple internal and external programs leveraging its Peptelligence platform. The technology has been developed and proven effective over the last decade to enable the safe delivery of peptide-based therapeutics and other molecules with low oral bioavailability. In addition to its internal development pipeline, Enteris' oral peptide delivery technology is the subject of several active external development programs, the most advanced of which include Tarsa Therapeutics' TBRIA, a submitted NDA for oral calcitonin for patients with postmenopausal osteoporosis, and Cara Therapeutics' CR845, a potent peripheral kappa opioid receptor agonist that completed Phase 2b studies for chronic pain and Phase 1 studies for chronic kidney-induced pruritis (itch). Further studies are planned for liver disease-induced pruritis using the oral formulation. In January 2017, Enteris entered into separate agreements with Sanofi, Ferring Pharmaceuticals, and KeyBioscience AG (a fully owned subsidiary of Nordic Bioscience) to develop oral tablet formulations of peptide therapeutics owned by each company.

About Enteris BioPharmaEnteris 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 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 http://www.EnterisBioPharma.com.

About Torreya PartnersTorreya Partners LLC is a leading boutique advisory firm that provides strategic advice and transaction assistance with Mergers & Acquisitions, Partnering and Financings to life science companies worldwide. Torreya Partners has offices located in London, Mumbai and New York. For further information, please visit https://torreya.com/

For Enteris BioPharma:     Brian Zietsman, President & CFO+1.973.453.3527

Enteris Media Relations:Jason RandoTiberend Strategic Advisors, Inc.+1.212.375.2665jrando@tiberend.com

For Torreya Partners:Tom Bird: +1.212.257.5806; tom.bird@torreya.comChristine Fischette: +1.973.978.0671 christine.fischette@torreyaadvisors.com

Cision View original content:http://www.prnewswire.com/news-releases/enteris-biopharma-announces-positive-results-from-phase-2a-clinical-trial-of-ovarest-oral-leuprolide-tablet-for-endometriosis-300577052.html

SOURCE Enteris BioPharma, Inc.

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