Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Oramed Pharmaceuticals has filed a protocol to the US Food and Drug Administration (FDA) to start a Phase IIa trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes.
Subscribe to our email newsletter
The protocol was filed under the company’s existing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications.
The double-blind, randomized, placebo controlled, seven-day trial design will be conducted at an inpatient setting on 24 type 1 diabetic patients and it is expected to start later this quarter.
Oramed CEO Nadav Kidron said, "With the encouraging data from our recent Phase IIa FDA trial on type 2 diabetic patients, we are moving forward on both the type 1 and type 2 indications by submitting this type 1 protocol to the FDA while gearing up for the Phase IIb multi-center trial on type 2 patients to take place later this year."
The company proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections.
Furthermore, oral administration provides the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver.