First Patient Dosed in Clinical Trial!
Concenter BioPharma Doses First Patient in a Clinical Trial Examining the Safety and Efficacy of Zygosid-50 Administered by Sub-Cutaneous Injection for Treating Patients with Type 2 Diabetes Mellitus
SHEBA Medical Center, Tel-Hashomer, Israel, doses first patient in a study to assess the safety and efficacy of Zygosid-50
Tel-Hashomer (Israel), August 5, 2021 – Concenter BioPharma Ltd., a biopharmaceutical company that is pioneering the development of a new class of medications for treating and preventing Type 2 Diabetes, announced yesterday that the first patient was dosed in its clinical trial. Prof. Amir Tirosh, M.D., PhD, Director, Division of Endocrinology, Diabetes and Metabolism, supervised the first administration of the study drug (Zygosid-50) at the Sheba Medical Center, Israel.
“We are excited to assess the efficacy and safety of Zygosid-50 in treating patients with high daily levels of blood glucose despite their current treatment. We are looking forward to the results of this clinical trial. We can now test the hypothesis that Zygosid-50 will correct the Insulin resistance so common among patients with Type II Diabetes (T2D) and provide the potent anti-inflammatory effect demonstrated so effectively in the pre-clinical studies,” said Prof. Amir Elami, Chief Medical Officer of Concenter BioPharma.
“While modern medications for T2D have somewhat improved the control of blood glucose levels and have demonstrated reduction in cardiovascular and renal complications, we still are in need of effective therapy against the culprit mechanism in the development of T2D, namely Insulin Resistance.,” added Mr. Dror Chevion, CEO of Concenter BioPharma. “Potentially, Zygosid-50 can reverse the downhill progress of the disease process, obviating the need for Insulin treatment and even become the monotherapy for T2D.”
The study has a single arm, including 10 participants with T2D who are currently treated with oral medications and/or injections (GLP1-RA) but not Insulin. Candidates with high average daily glucose levels, HbA1c > 7.5 and BMI>27 despite the current therapy (that does not not include Insulin injections) are screened for inclusion in the study. Those found eligible receive a daily sub-cutaneous injection of Zygosid-50 in escalating doses, for 12 weeks.
Primary objective of the study is to demonstrate the efficacy of Zygosid-50 in decreasing the average daily blood glucose levels towards normal. Secondary endpoints include improvement of HbA1c by 0.3% or greater, improvement of lipid profile and reduction of Insulin resistance (as determined by HOMA-IR). Outcomes will be assessed by comparing disease parameters at the end of 12 weeks with the pre-study parameters.
About Zygosid-50 mode of action with dual benefit
Zygosid-50 is the zinc complex of desferrioxamine B, capable of entering affected cells to chelate labile and redox-active iron ions and increase the intracellular levels of Zinc ions, important for Insulin packaging and safe storage, modulation of insulin-signaling-pathways, regulation of lipids metabolism (lipogenesis and lipolysis), and adipose tissue inflammation.
About Concenter BioPharma
Concenter BioPharma, founded in 2019 based on IP created by a team led by Prof. Mordechai Chevion, at the Hebrew University and Hadassah Medical Center (Jerusalem, Israel), is a biopharmaceutical company that is pioneering the development of therapies targeting Inflammatory processes involved in the pathogenesis of obesity and Insulin resistance. The company is focusing on treating and preventing Type 2 Diabetes.
For further information, please visit https://www.concenterbiopharma.com.
Dror Chevion, CEO
mobile: +972 545 767 050
Amir Elami, M.D., CMO
mobile: +972 507 874 873