Zealand pharmaceutical low blood sugar treatment drug dasiglucagon 3 phase reached the main end point
March 22, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 20th, Danish pharmaceutical company Zealand Pharma announced that the first international multi-center clinical phase 3 trial of the drug candidate dasiglucagon for severe hypoglycemia reached the primary study endpoint and the key secondary endpoint. No anti-drug antibodies with therapeutic induction or therapeutic enhancement were detected in the assay.
Dasiglucagon is a world-first stable analog of glucagon discovered and developed by Zealand. The drug has unique stability in liquid preparations and is suitable for use in ready-to-use treatment pens. The results of the clinical phase 2 trial showed that compared with the active control drug, dasiglucagon can rapidly increase the blood sugar level of insulin-induced hypoglycemia, and the blood sugar rise lasts longer and the effect is more obvious.
The purpose of this Phase 3 trial was to evaluate the immunogenicity of 90 patients with type 1 diabetes who received a single dose of dasiglucagon (0.6 mg) after repeated subcutaneous administration, and assessed safety and tolerability. In the trial, Dasiglucagon was compared to a natural glucagon powder formulation that was dissolved in buffer prior to injection and used immediately. The primary and critical secondary endpoint of the trial was to assess the risk of treatment-induced or therapeutically enhanced anti-drug antibodies following administration of three doses of dasiglucagon or GlucaGen. An examination of the test data indicated that dasiglucagon did not induce or enhance anti-drug antibodies.
Adam Steensberg, chief medical and development officer of Zealand, commented: "The positive result of obtaining clinical phase 3 trials is the important advancement of HypoPal rescue pens for the development of severe hypoglycemia. Severe hypoglycemia remains one of the biggest concerns of patients with insulin-dependent diabetes. In the United States alone, approximately 300,000 people are hospitalized each year for the disease. We are now looking forward to completing the ongoing Phase III clinical trials in the end of this year, and we are still fully committed to providing easy use for patients with life-threatening diseases. s solution."
More results from the trial are expected to be announced in the second quarter of this year, and all results will be announced at the appropriate scientific meeting. In addition to this trial, a key phase 3 efficacy trial was initiated at the end of 2017. Patient recruitment is on schedule and expected results are available in the second half of 2018.
Patients with type 1 diabetes have problems with insulin deficiency and inappropriate glucagon secretion. These two hormones are essential for ensuring blood sugar stability and maintaining a healthy level. Therefore, patients must monitor and adjust their blood glucose levels to maintain proper glycemic control, as both high blood sugar and low blood sugar can affect their health.
Hypoglycemia is caused by a severe drop in blood sugar levels, which can be life-threatening. The disease is mainly related to insulin therapy and is one of the most concerned issues for insulin-dependent patients and their families. Severe hypoglycemia mainly occurs in patients with type 1 diabetes and type 2 diabetes with insulin medication. Severe hypoglycemic events are characterized by confusion, seizures, and frequent loss of consciousness. Natural glucagon, currently marketed to treat severe hypoglycemia, requires the powder to be dissolved in an aqueous solution and then must be used immediately due to the limited stability of the drug. (Sina Pharmaceutical Compilation / David)
Reference source: https://cws.huginonline.com/Z/136974/PR/201803/2177667_5.html
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