Since its launch earlier this year, initial uptake of Sanofi and Mannkind’s inhalable insulin product Afrezza has been underwhelming. Despite this, there is still demand for alternatives to injections for diabetes sufferers, according to Israeli pharma firm Oramed which is developing its own insulin tablet.
“I think it has shown that there is a real desire for alternative modes of delivering insulin,” CEO Nadav Kidron told in-Pharmatechnologist.com. However, “most people would rather oral over almost any other way of delivering the medication.”
The candidate ORMD-0801 uses Oramed’s POD (Protein Oral Delivery) technology platform which enables the delivery of large molecule APIs (in this case insulin) in a tablet form, rather than via injection, and the study protocol for a Phase IIb trial has just been submitted to the US Food and Drug Administration (FDA).
“The technology works to protect the active agent throughout the digestive system so that it remains intact and therapeutically active,” Kidron explained, adding it “also works to improve absorption of the active agent/insulin in the small intestine.
“It’s a holistic approach to oral delivery of proteins which is often ignored by others in the field.”
The planned double-blind, randomised study involves around 180 patients across 30 sites in the US and following trial success the firm will move into Phase III potentially in collaboration with a Big Pharma, though Kidron would only reveal that such “discussions are on-going.”
He added: “This is the last submission to the FDA in order to allow for the initiation of the Phase IIb [trial].”
Oramed is also investigating its oral insulin in type 1 diabetes and is one of several pharma firms – including Novo Nordisk - looking to offer enhanced compliance through an oral delivery method for patients requiring insulin.