New advances in oral insulin! Thyme bio-recombined human insulin intestinal capsule (ORMD-0801) initiates Phase III clinical.

Recently, Insight database shows that Hefei Tianma Bio and Israel Oramed co-developed a new oral insulin drug ORMD-0801 in China to start Phase III clinical, oral insulin is a big step closer to the market.
The main purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of the treatment of co-recombinant human insulin intestinal capsules (ORMD-0801 gelatin softgels) in subjects with type 2 diabetes who had poor blood sugar control of oral hypoglycemic drugs.
secondary objective was to assess the safety and immunogenicity of the combined ORMD-0801 treatment in subjects with type 2 diabetes who had poor oral anti-sugar drugs.
the number of people scheduled to join the group is 470.
the main researchers are Ning Guang academicians from Ruijin Hospital, affiliated with Shanghai Jiaozhou University School of Medicine, and 39 hospitals from 18 provinces and cities, including Shanghai, Jiangsu, Guangdong, Beijing, Henan and Heilongjiang.
ORMD-0801 is expected to be the first oral insulin capsule product ORMD-0801 developed by Oramed, which specializes in the development of oral protein dosing technology, with an exclusive new protein oral drug (POD) technology, the technology at its hands to convert injection dosing into oral drugation has been the world leader.
in addition to oral insulin, a combination of oral GLP-1 capsules (ORMD-0901), oral insulin and oral GLP-1 are currently being studied and are in clinical trials.
, oral insulin capsules (ORMD-0801) are by far the fastest progressing and are already in Phase II clinical trials.
November 2015, Hefei Tianma Bio signed an investment agreement with Oramed and the exclusive development rights of oral insulin ORMD-0801 in China (including Hong Kong and Macau).
In January 2019, Thyme Bioalic Insulin Capsules (ORMD-0801) were approved for clinical trials by the National Drug Administration, and in March 2019, Hefei Tianma Bio announced the completion of the world's first oral insulin production line, which will be a key milestone in the development of innovative drugs for the treatment of diabetes worldwide.
the Insight database, in June 2019, Timo Bio launched Phase I clinical phase I (CTR20190316) in China.
November 2019, Tima Bio and Oramed announced the latest clinical results for oral insulin, and the success of the ORMD-0801 IIb trial in type 2 diabetes showed good sugar-lowering and safety characteristics.
This is a placebo-controlled, double-blind, randomized, 90-day dose-range IIb phase trial conducted in patients with type 2 diabetes with poor oral antisaccharide therapy, evaluating the primary therapeutic endpoint and safety endpoint of HbA1c reduction from baseline to 12 weeks when ORMD-0801 was given in different treatment options over the dose range.
in this trial, patients treated with ORMD-0801 at random once a day reached the primary endpoint, with Hb A1c falling by an average of 0.6% over baseline levels, or by an average of 0.54% (p-value of 0.036) after a placebo correction.
HbA1c decreased by an average of 0.54%, which showed clinical significance for patients and improved blood sugar control, thereby reducing the risk of diabetes-related complications.
in China, a large population base coupled with a high prevalence rate has led to a rapid increase in the number of people with diabetes.
data show that the number of people with diabetes (aged 20-79) in China climbed from 0.43 billion to 114 million between 2010 and 2017, and is expected to reach more than 150 million in 2045.
domestic insulin market is also expanding, reaching $57.6 billion in 2018, but this represents only 10% of the global insulin market.
is more attractive to patients than insulin injection, including increased patient comfort and compliance, reduced risk of infection, cost-effectiveness, etc.
In addition, oral insulin absorbed through the intestines passes through the liver first before entering the bloodstream, which actually simulates the natural position and gradient of insulin in the body, and this innovative treatment potentially slows the development of the disease and delays or even eliminates late-stage complications by allowing patients to take insulin orally early in treatment.
these advantages make oral administration the most popular preferred route of drug administration, so it seems that once oral insulin is on the market, the market potential can not be ignored.
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