Tianmai biorecombinant human insulin intestinal capsule (ORMD-0801) started Phase III clinical.

Recently, insight database shows that Hefei Tianmai Bio and Israel Oramed co-developed the oral insulin new drug ORMD-0801 in China to launch Phase III clinical, oral insulin from the market is a big step closer.
The main purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of joint recombinant human insulin intestinal capsules (ORMD-0801 gelatin softgel capsules) in patients with type 2 diabetes who had poor blood sugar control.
secondary objective was to assess the safety and immunogenicity of the combined ORMD-0801 treatment in patients with type 2 diabetes who had poor oral anti-sugar drug efficacy.
number of people planned to join the group is 470.
researchers are Ning Guang from Ruijin Hospital, affiliated with Shanghai Jiaojiang University School of Medicine, and 39 hospitals from 18 provinces and cities, including Shanghai, Jiangsu, Guangdong, Beijing, Henan and Heilongjiang.
ORMD-0801, which is expected to be the first oral insulin capsule product, ORMD-0801, was developed by Oramed, a company that specializes in the development of oral protein giving technology and has an exclusive new protein oral dosing (POD) technology, which is a world leader in converting injections into oral dosing.
in addition to oral insulin, oral GLP-1 capsules (ORMD-0901), oral insulin, and oral GLP-1 combination therapies are currently in clinical trials.
, oral insulin capsules (ORMD-0801) are the fastest-growing and are already in Phase II clinical trials.
photo source: Oramed's official website In November 2015, Hefei Tianmai Bio signed an investment agreement with Oramed Corporation and the exclusive development rights of oral insulin ORMD-0801 in China (including Hong Kong and Macau).
In January 2019, Tianmai Bioaltic Insulin Capsules (ORMD-0801) were approved for clinical trial by the State Drug Administration, and in March 2019, Hefei Tianmai Bio announced the completion of the world's first oral insulin production line, which will be a critical milestone in the development of innovative drugs for the treatment of diabetes worldwide.
, according to the Insight database, in June 2019, Tianmai Bio initiated Phase I clinical (CTR20190316) of ORMD-0801 in China, which is now complete.
November 2019, Tianmai Bio and Oramed announced the latest clinical results of oral insulin, orMD-0801 in the IIb trial of type 2 diabetes, which resulted in good sugar reduction and safety properties.
This is a placebo-controlled, double-blind, randomized, 90-day dose-range IIB phase trial in patients with type 2 diabetes who were poorly treated with oral antisaccharides, which assessed the primary efficacy endpoints of HbA1c reduction from baseline to 12 weeks when ORMD-0801 was given at different treatment options in the dose range.
In this trial, patients who were treated with ORMD-0801 randomly once a day reached the primary endpoint, with an average decrease of 0.6% in Hb A1c than the baseline level, or an average decrease of 0.54% in Hb A1c after a placebo correction.
0.54% decrease in HbA1c, a data that demonstrated clinical significance for patients and improved blood sugar control, thereby reducing the risk of diabetes-related complications.
, china's large population base combined with high prevalence has led to a rapid increase in the number of people with diabetes.
data show that the number of people with diabetes in China (20-79 years old) climbed from 0.43 million to 114 million between 2010 and 2017 and is expected to reach more than 150 million by 2045.
the domestic insulin market is also expanding, reaching $57.6 billion in 2018, yet this represents only 10% of the global insulin market.
, oral dosing is more attractive to patients than insulin injections, including increased patient comfort and compliance, reduced risk of infection, cost-effectiveness, and so on.
In addition, oral insulin absorbed through the intestines passes through the liver first before entering the bloodstream, effectively simulating the natural position and gradient of insulin in the body, an innovative treatment that 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 method of drug administration, so it seems that once oral insulin is on the market, the market potential can not be sniped down.
original title: Oral insulin new progression! Tianmai Biorecombinant Human Insulin Intestinal Dissolved Capsules (ORMD-0801) initiate Phase III clinical.