ORMD-0801 is being developed as an oral form of insulin for type 1 and type 2 diabetes and uses Oramed Pharmaceuticals’ POD (Protein Oral Delivery) technology platform.
And this week, the Israel-based company announced it has received clear guidance from the US Food and Drug Administration (FDA) to submit its lead candidate ORMD-0801 through the Biologics License Application (BLA) regulatory pathway.
“We are currently reviewing the guidance given to us from the FDA just last Thursday and will be able to outline our forward-looking pathway in the coming week,” COO Josh Hexter told in-Pharmatechnologist.
“We plan on continuing to manage the near term clinical trials and will likely look to partner with a large pharmaceutical company who can manage the sales, distribution and support of a chronic care/diabetes therapy into the marketplace.”
The firm has already teamed up and licensed its oral insulin product to Hefei Tianhui Incubator of Technologies for the Chinese market and Hexter said it would look for similar partnering opportunities globally as it manages the later stage clinical trials.
Alternative insulin delivery
The POD platform consists of protease inhibitors and absorption enhancers enclosed within an enteric coated pill. The coating is pH sensitive and only opens when the pill is past the stomach enabling the delivery of large molecule APIs (in this case insulin) orally, rather than via injection.
“We have certainly shown an ability to deliver insulin orally in our Phase IIb study and look forward to running further studies towards approval,” Hexter said.
He added other than Indian drugmaker Biocon, he is not aware of any oral insulin which is actively pursuing US regulatory approval.
In-Pharmatechnologist also asked Hexter about the lessons learned from Afrezza, an inhalable human insulin product made by MannKind Corporation which has suffered from low sales and a commercialisation partner – Sanofi – which pulled out of the deal after a year.
“Sanofi/Mannkind had a real uphill battle commercially speaking. The FDA required that people have their lungs checked prior to starting this treatment (which most people do not want to do) and even in an elegant delivery device people have shown they are averse to using such devices.
“Oral insulin is a pill (which most people are happy to take) and as it physiologically mirrors the way the body gives itself insulin (i.e. first pass of liver) it has many health benefits an inhaled insulin could never have.”