Drug delivery firm Unigene filed for bankruptcy last month but key personnel have joined Enteris Biopharma, a newly launched company which acquired the rights to Unigene’s Peptelligence – an oral peptide and small molecule delivery platform – following a public auction in April.
According to Chief Scientific Officer Dr. Nozer Mehta, the delivery platform is applicable to both small molecule drugs with low bioavailability as well as biopharmaceuticals and with its unique mechanism has the ability to enhance solubility and intestinal permeability.
One of the unique aspects of the platform, Mehta told in-Pharmatechnologist.com, is the choice of excipients. As well as increasing permeability, organic acid acts as a protease inhibitor by protecting the API (active pharmaceutical ingredient) in the intestine, and acyl carnitine increases the drug’s solubility plus aids absorption across the intestinal wall.
“The major competitors that we are aware of all use the transcellular transport mechanism,” he said, where “the molecule has to pass through both the apical and the basolateral membranes of the intestine.”
However, with the Peptelligence platform “molecules can go through the paracellular route as the excipients open the gap between the intestinal wall” allowing absorption between cell gaps, he added.
Mehta also spoke of the enteric coat which is pH responsive, preventing the drug from being opened up and degraded in the stomach. Though this mechanism alone is not unique, the excipients “creates an acidic micro-environment in the intestine” so when the tablet opens up the API is released in high concentration within a small area.
Progress and Pharma Interest
The platform has previously been licensed to Tarsa Therapeutics who used it to successfully produce an oral formulation of calcitonin – an approved treatment for postmenopausal osteoporosis – in a Phase III trial.
“No other company has completed a Phase III study of an oral naturally occurring peptic,” Brian Zietsman, President and CFO of Enteris, told us, adding that such success opens up the opportunities of the platform.
Furthermore, though newly formed there is already a customer base with a number of relationships previously forged by Unigene continuing with Enteris, according to Associate Director Justin Romanowski.
He told this publication Enteris was involved in “15 sponsored programmes incorporating both Big Pharma and small biotech firms,” with the technology appealing to both the industry and final-user ends of the healthcare market.
“For patients/physicians it can eliminate the stigma of needle drugs and increase the compliance rates,” he said.
However, for pharma the technology works as a way of increasing the lifecycle of a product, converting a current patented subcutaneous or IV drug into an oral delivery form and therefore potentially adding years of exclusivity to a therapy.