Enteris Doses First Woman in Phase 2a Clinical Trial for Endometriosis

BOONTON, N.J., Aug. 24, 2017 — Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced today that the first woman has been dosed in its Phase 2a clinical trial to evaluate Ovarest^®, an oral formulation of leuprolide, for the treatment of 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.

Ovarest^® represents Enteris’ most clinically advanced internal product candidate and underscores Enteris’ rapidly advancing clinical development pipeline targeting underserved patient populations in women’s health. The Phase 2a trial is designed as a randomized, open-label, parallel-group, active-control Phase 2a pharmacokinetics (PK) / pharmadynamics (PD) study in 32 healthy female volunteers. The study will determine the safety and evaluate the PK/PD metrics of two different oral doses of Ovarest^® in comparison to the leuprolide formulation approved for the treatment of endometriosis, Lupron Depot^® 3.75 mg, a monthly intramuscular injection.

“Initiation of the Ovarest^® Phase 2a clinical trial is a significant milestone for Enteris and underscores our commitment to building an internal product pipeline of innovative oral therapeutics that address underserved medical needs in women’s health,” said Joel Tune, chief executive officer and executive chairman of Enteris BioPharma. “Endometriosis affects nearly six million women in the United States, and there have been few advancements in the space to provide these women with more patient-friendly treatment options. Ovarest^® has the potential to become a high-value and broadly adopted therapeutic for the treatment of endometriosis, and together with Tobrate™, demonstrates the capabilities of our Peptelligence^® platform to transform currently available injectable drugs into patient-friendly oral formulations.”

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, an oral calcitonin for patients with postmenopausal osteoporosis and Cara Therapeutics’ CR845, a potent peripheral kappa opioid receptor agonist. 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 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 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. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit http://www.EnterisBioPharma.com.