Dive Brief:
- Delivery technology specialist Enteris BioPharma, Inc. has announced positive Phase 2a data from an endometriosis study of its oral leuprolide formulation, Ovarest.
- In the study, Ovarest suppressed estradiol levels, which are closely linked with efficacy in treating endometriosis, confirming proof-of-concept.
- A Phase 2b trial is planned for later this year.
Dive Insight:
Endometriosis affects one in ten or more of women in the U.S. between the ages of 15 and 44, leading to pelvic pain and infertility, productivity loss and lower quality of life. One treatment used is leuprolide, a GnRH analog, often given as a monthly injection (Lupron).
Ovarest is a potential oral alternative and uses the company's Peptelligence platform, developed to allow oral delivery of injected molecules, including peptides.
"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, CEO and executive chair of Enteris.
Enteris plans to move Ovarest into Phase 2b later in 2018, with the results expected to "make Ovarest a Phase 3-ready asset," according to Tune. The company will also begin development in uterine fibroid tumors and prostate cancer, with other potential indications, including in vitro fertilization protocols and central precocious puberty.
"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," added Tune.
Privately-held Enteris is considering partnerships and other sources of funding to move forward its internal pipeline, including Ovarest, Tobrate (oral tobramycin), and Octreotide (somatostatin analog), and pipeline projects in metabolic disorders and other indications. To enable this, Enteris has signed a deal with boutique investment banking advisory firm Torreya Partners.
Other companies are working on treatments for endometriosis.
AbbVie's elagolix has a user fee date of April 2018 with the Food and Drug Administration; Allergan, Inc. has picked up Repros Therapeutics, Inc., which has a vaginal product in Phase 2; and Astellas is developing an oral GnRH antagonist, ASP1707, in Phase 1/2.