Latest! Tianmai Bio Oral Insulin Capsules Announce Latest Clinical Trial Results

Founded in 2006, Oramd is an Israeli pioneer in platform technology providing oral solutions for protein drugs that are often prescribed for injection, and has developed new protein oral administration (POD) technology based on more than 30 years of research by scientists at Hadassah Medical Center in JerusalemCurrently, oral insulin capsules (ORMD-0801) are the only insulin capsules in the world that are close to clinical phase III and are expected to become the world's first insulin capsule products to be marketedto participate in the ORMD-0801 Phase IIb clinical trial for persistent diabetics who are not taking oral sugar-reducing drugs (single, or two-drug, or three-drug combination)According to the results of the trial, after 3 months of daily oral insulin capsules, the patient's blood sugar decreased significantly and the weight was controlledIn addition, the results showed good effect on sugar reduction, but also showed excellent safety characteristics, no drug-related serious adverse events, did not increase the frequency of hypoglycemia eventsspecifically, this placebo-controlled, double-blind, randomized, 90-day dose range IIb phase trial in patients with poor oral anti-sugar treatment, assessed when ORMD-0801 was administered withdifferent treatment options within the dose range, from baseline to 12 weeks of reduced HbA1c major therapeutic endpoints, and safety endpointsIn this trial, patients who were randomly treated with ORMD-0801 once a day reached the primary endpoint, with an average decrease of 0.6% in Hb A1c than baseline levels, or an average decrease of 0.54% (p value s 0.036) for Hb A1c after correction of the placeboHbA1c decreased by an average of 0.54%, a data that reflects clinical significance for patients and indicates improved blood sugar control, thereby reducing the risk of diabetes-related complicationshas long been the most effective way to treat diabetes, but now all countries in the world clinical insulin delivery is mainly in the form of injection, for the global diabetes patients, in the face of this life-long, chronic, long-term control of the disease, the continuous form of injection of medicine to a large extent for the patient's life has a very big problemIn contrast, oral insulin capsules have a variety of advantages such as convenience of medication, eliminating skin pain caused by injection drugs, and skin and fatty lesions that may occur locallyand oral insulin research and development has a higher technical barrier, the relevant data show that oral insulin as a protein oral administration, the technical difficulties need to be overcome in addition to the digestive system on the degradation of proteins and peptides, but also to solve the protein through the digestive system to reach the target of action, as well as the individual differences of drug absorptionthe success of this ORMD-0801 clinical trial means that the success of insulin capsule sin-good, a revolutionary new breakthrough in the way insulin is injected, will enable hundreds of millions of diabetics around the world to get rid of the pain of multiple daily insulin injections, greatly improve the compliance of patients with insulin use, which is of great significance to improve the condition of diabetes patients, improve the quality of life of patients and their families"These results further demonstrate that ORMD-0801 is a safe and effective insulin treatment," said Nadav Kidron, chief executive ofOramdNext, we look forward to reading data for the second queue of the trial in the first quarter of 2020 and discussing the Phase III trial further with the FDAWe are passionate about the potential of ORMD-0801 as we enter the final stages of developmentJoel Neutel, lead researcher of the ORMD-0801 IIb trial and director of the Orange County Research Center in Tasin, California, added: "This Phase IIb trial provides statistically significant clinical data and does not report hypoglycemia events, supporting the unique mechanism of oral insulin in Oramd Insulin absorbed by the intestines delivers insulin directly to the liver, simulating the natural transport of insulin in the body, resulting in a more physiological supplement of insulin, which is effectively treated and reduces the risk of hypoglycemia and weight gain At the same time, the oral insulin capsule ORMD-0801 has been approved by NMPA and is undergoing clinical trials in China (Note: Limitations on the original text)