Enteris BioPharma this week touted positive results from the final treatment arm of a Phase IIa trial of Ovarest, the company’s oral formulation of leuprolide.
The drug is designed as an alternative to the injectable therapies available for people with endometriosis.
Data from the last treatment arm of Enteris’ Phase IIa trial showed that the optimized Ovarest formulation and dose triggered estradiol suppression in healthy volunteers at levels that were in line with Lupron Depot, an injectable formulation of leuprolide.
Based on the positive data from its Phase IIa trial, Enteris reported that it plans to advance Ovarest into Phase IIb development.
“The objective of the last Phase IIa treatment arm was to demonstrate that an optimized tablet formulation at a 10 mg twice-daily dose would further improve estradiol suppression. We are very pleased to report that the data hit the mark, showing that Ovarest tablets are now expected to demonstrate similar efficacy to Lupron Depot and other products developed and being developed to treat endometriosis,” executive chairman & CEO Joel Tune said in prepared remarks. “It is Enteris’ strategy to partner Ovarest and all its internal pipeline products either at the proof-of-concept stage or before they enter Phase III.”
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 last year with Drug Delivery Business News.
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