Enteris BioPharma has announced positive results from its proof-of-concept Phase IIa clinical trial of an oral formulation of the synthetic hormone leuprolide. Ovarest was successful at supressing estradiol, which is used as a measure of efficacy in treating endometriosis.
While drugs like leuprolide are usually injected, Enteris’ goal is to make oral formulations of these medications to provide patients with an easier drug delivery method. The injectable version of the drug – sold under the trade name Lupron – is already used to treat endometriosis, among other conditions, including uterine fibroids and prostate cancer.
Endometriosis affects at least 10 percent of women in the US. The condition is characterized by the growth of uterine tissue outside of the organ and results in pelvic pain, lower quality of life and potential fertility issues.
“The positive results from the Phase IIa 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 IIb trial, now that proof-of-concept has been established in our Phase IIa study.”
According to Tune, the Phase IIb study is already planned for later in 2018. The company also hopes an oral version of leuprolide could be approved for the same indications as its injectable counterpart.
“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,” said Tune.
Enteris is utilizing its Peptelligence® platform in the development of Ovarest, which is designed to convert injectable peptides and other small molecules in oral formulations. The company is also working with Torreya Partners, a New York City-based global investment banking company, to help them identify strategic partnerships and market opportunities.
“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.”