Small New Jersey delivery specialist Enteris BioPharma is off to a fast start. The brand-new company, which only just opened its doors in April of this year, entered a licensing agreement for an undisclosed amount with Danish Nordic Bioscience--a partner of Novartis ($NVS) and Merck Serono--to make use of Enteris's oral-delivery tech for peptides and small molecules.
Enteris's platform, called Peptelligence, is an enteric-coated tablet designed to loosen tight junctions in the intestinal tract for paracellular (between the cells) transport. It also contains citric acid, which helps ease delivery to cells and overcome the obstacles associated with oral peptide and small-molecule applications. Before partnering with Nordic, Enteris had already collected positive data in several clinical studies, including a Phase III pivotal trial for the oral treatment of osteoporosis with calcitonin.
The trouble with oral delivery of peptides in particular is the amount of the drug that stays viable enough in the digestive tract to enter the bloodstream. A peptide such as insulin with a complex structure, for instance, tends to break down in the harsh environment of the gut, so protecting the molecule is paramount to its success as an oral option.
In the arena of oral peptides, Israel's Oramed ($ORMD) has been in the spotlight lately, most recently enrolling a Phase IIa trial for its Type 1 diabetes treatment. And tech behemoth Google ($GOOG) is entering the fray as well, investing in novel oral treatments, putting $10 million toward Rani Therapeutics last month. It's not a quiet field by any means, but a high bioavailability could make the difference, Enteris says.
"The proof of the pudding is in the absolute bioavailability that we achieve," Enteris Vice President of Business Development Timothy Saxon told FierceDrugDelivery. "If you have a drug injected, then 100% of the drug gets in your bloodstream. If you swallow a regular tablet, you're very often getting quite modest bioavailability. And in this field, where we're developing hard-to-deliver drugs like peptides, clients were thrilled when we were getting 15% figures, and in small molecules even higher."
It's this bioavailability that helps Enteris stand out to a company like Nordic, Saxon and Enteris CFO Brian Zietsman said. Nordic, beyond its leading biomarker business, is developing several therapeutics for diabetes, obesity and inflammatory conditions such as osteoporosis and osteoarthritis, all of which would benefit from oral delivery. And Enteris is looking to extend its platform's viability into the delivery of antibiotics and cancer drugs.
"Peptide drugs are the focus of the work, but what we're able to do now is focus in on a number of small molecules--antibiotics that are now only available by injection," Zietsman said over the phone. "The same is true of a number of anticancer drugs such as taxanes, which is a huge area of cancer treatment. The treatment may be started in hospital or in the clinic, but in an oral form they can continue after that. It could be quite transformational."
Zietsman and Saxon say Enteris is in talks with several other partnering prospects, bolstered by its patents, which extend beyond 2030.
- here's the release