ORMD-801
Diabetes is a chronic condition characterized by hyperglycemia,
or elevated blood glucose levels. If left untreated, diabetes may lead to
complications such as cardiovascular disease, chronic renal failure,
retinopathy and amputations.
Type
2 diabetes (T2DM) is a progressive disease characterized by impaired ß cell
function and insulin resistance. There are over 340 million type 2 diabetics
worldwide with an economic burden of close to half a trillion dollars annually.
Orally
administered insulin should bring with it enhanced patient compliance. In
addition, intestinally absorbed-oral insulin actually mimics insulin’s natural
location and gradients in the body by first passing through the liver before
entering the bloodstream.
Oramed’s
oral insulin (ORMD-0801) has the potential to create a new paradigm in the
treatment of diabetes by oral delivery of insulin at an earlier stage of
treatment, potentially slowing disease progression and delaying or even
eliminating late-stage complications.
Oramed Pharmaceuticals’ POD™ (Protein Oral Delivery) technology
has been designed to (1) protect orally delivered proteins from detrimental
enzymatic activity within the gastrointestinal tract and (2) to enhance their
absorption across the intestinal wall.
The
active protein is encapsulated in a capsule that features a highly protective
coating that remains intact in the most acidic segments of the gut, as well as
enzymatic support provided by specialized protease inhibitors.
Drug
availability is further secured by an absorption enhancer supplement that
facilitates protein passing across the intestinal barrier.
By
preventing protein-drug breakdown in the gastrointestinal tract and promoting
its crossing the small intestine, this breakthrough solution brings oral
protein-drug delivery significantly closer to a reality.
ABSTRACT
FROM: J. Diabetes Science and Tecnologic from Basic Science to
Clinical Practice
Optimal
coverage of insulin needs is the paramount aim of insulin replacement therapy
in patients with diabetes mellitus. To apply insulin without breaking the skin
barrier by a needle and/or to allow a more physiological provision of insulin
are the main reasons triggering the continuous search for alternative routes of
insulin administration. Despite numerous attempts over the past 9 decades to
develop an insulin pill, no insulin for oral dosing is commercially available.
By way of a structured approach, we aim to provide a systematic update on the
most recent developments toward an orally available insulin formulation with a
clear focus on data from clinical-experimental and clinical studies. Thirteen
companies that claim to be working on oral insulin formulations were
identified. However, only 6 of these companies published new clinical trial
results within the past 5 years. Interestingly, these clinical data reports
make up a mere 4% of the considerably high total number of publications on the
development of oral insulin formulations within this time period. While this
picture clearly reflects the rising research interest in orally bioavailable
insulin formulations, it also highlights the fact that the lion’s share of
research efforts is still allocated to the preclinical stages.
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