Enteris BioPharma announced 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."
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.