Privately-held biotech Enteris BioPharma touted data today from a Phase IIa trial of its oral leuprolide formulation, Ovarest.
The Boonton, N.J.-based company reported that its product triggered significant suppression of estradiol, which is correlated with efficacy in treating endometriosis.
“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,” chairman & CEO Joel Tune said in prepared remarks.
“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. It is our expectation that the Phase IIb trial planned for later this year will satisfy the requirements to make Ovarest a Phase III-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.”
The chief executive added that his company is working with financial consultant Torreya Partners to identify potential partnerships. Enteris has already inked a number of deals with players in the pharmaceutical industry, including Sanofi (NYSE:SNY). The two companies are working on developing an oral peptide for Type II diabetes.
“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,” Tim Opler of Torreya Partners added. “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.”
Enteris’ ‘Peptellingence’ platform is designed to overcome the challenges of oral peptide delivery. A person’s gastrointestinal tract degrades and digests peptides and a normal peptide can’t break through the intestinal cell layer to be absorbed.
To tackle this problem, Enteris has developed a coating that stops the peptide from opening in the stomach. Instead, the therapy dissolves only once it reaches the small intestine.
The company also uses a compound to boost the intestinal cell layer’s permeability, temporarily widening the gaps between cells to facilitate drug transfer, Tune explained in an interview with Drug Delivery Business News.
“Six million women in the U.S. have been diagnosed with endometriosis, so [Ovarest] would help them immensely,” he said. “We’re just very excited about being able to potentially help that many patients.”