Oramed reports Phase IIb oral insulin trial success

Biomed (Illustration: Shutterstock)

The Israeli drug developer said the study was the first time an oral solution showed a significant drop in blood sugar at night.

Israeli drug development company Oramed (Nasdaq: ORMP) announced Wednesday the success of its Phase IIb study for its insulin capsule. The primary goal of the trial to reduce blood insulin levels at nighttime was achieved, without a significant increase in hypoglycemic events (a drop in blood sugar below the healthy amount).

Its Nasdaq share price jumped by 25% as the news of the announcement spread. Oramed is preparing for the third phase of clinical trials. The success of Phase IIb means the company will receive the second portion of the investment from Chinese company HTIT, partly owned by Sinopharm, which had committed to investing up to $50 million in Oramed based on the achievement of certain conditions.

Thus, Oramed will receive the majority of the $50 million dollars it was promised. Even before the additional injection, the company had $25 million on hand, which it believed would suffice until 2018. Now that operating budget will at the very least double.

Oral insulin is not a replacement for injections but is meant to treat Type 2 diabetics before they become insultin-dependent. Currently some of those patients receive no treatment, some are treated with new medications like GLP1; at later stages, they receive delayed-release insulin (like Lantus) in the nighttime, to prevent any spikes. The oral insulin will replace the delayed-release insulin which is currently injected and works using a different mechanism.

Former Pfizer executive and current director and chair of the Oramed scientific advisory board Dr. Michael Berelowitz said: Oral insulin goes straight to the liver and prevents the liver from turning foods like starches, amino acids, and fat into glucose. The liver will take on that operation if blood sugar levels are low because the brain needs a consistent supply of glucose for proper functioning. During the day the liver doesnt receive orders to produce glucose because we have the starches from our meals.

How does the liver know if theres enough sugar in the blood? The insulin tells it. When there are high levels of sugar in the blood from a meal, the insulin reaches the liver and signals to not produce glucose. Type 1 diabetics have no insulin and their liver makes glucose all day and all night. Type 2 diabetics produce bad insulin, and their liver also produces glucose all day and all night. Then the levels of glucose in the blood are too high and there is damage to the body.

Our insulin works exactly like the natural insulin in the liver. The injected insulin works differently. Instead of preventing the production of glucose by the liver, it send the excess glucose to muscle and fat cells.

Why is that bad?

Because with that method you could have incidents of excessive drops in sugar hypoglycemia which is also not good for the body.

So the doctor examining your data is essentially looking to see if your product works like delayed-release insulin but without the hypoglycemic events?

The current trial compared the product to a placebo, and it showed a significant reduction in sugar levels in the blood at night, without side effects or hypoglycemia.

The company said it would be possible to make some comparisons between its product and delayed-release treatments once the full results of the clinical trial are published in the coming months.

The study was conducted at 33 medical centers with 180 patients under protocols concocted by the US Food and Drug Administration.

Oramed CEO Nadav Kidron said, These results are very exciting; this is the first time an oral insulin solution managed to achieve a significant drop in sugar levels in the blood during the nighttime. It is also proof of the feasibility of the technological platform developed by Prof. Miriam Kidron which also serves as the basis for the development of another of our products an oral GLP1 treatment which will soon start a large efficacy trial.

Entera, a subsidiary of DNA, is developing an oral treatment for osteoporosis based on technology which was also originally developed at Oramed from the research conducted by Prof. Kidron but a different technology.

Published by Globes [online], Israel business news - www.globes-online.com - on May 19, 2016

Copyright of Globes Publisher Itonut (1983) Ltd. 2016

Biomed (Illustration: Shutterstock)
Biomed (Illustration: Shutterstock)
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