Clinical trial underway - updates
March 2021 Update
Production of the trial drug has already started. All other preparations for the clinical trial are performed concomitantly with the hope that external events (Covid-19, Elections...) will not interrupt or cause delays.
The initiation visit with the team at SHEBA is set to March 30th, following which the SHEBA team will proceed with the screening process and recruit the participants, so that trial will start in April, as planned.
February 2021 Update
On January 18th, 2021 the Israeli Ministry of Health (MoH) granted the final approval to perform the clinical trial at the SHEBA Medical Center.
The trial includes 10 patients with Type 2 Diabetes. These type 2 diabetics suffer from high daily glucose levels, and high glycated Insulin (HbA1c) despite optimal therapy they are currently receiving (not including Insulin injections). The participants will receive Zygosid-50 (the trial drug) daily, for 12 weeks.
We anticipate that the Zygosid-50 treatment for 12 weeks will demonstrate both safety and efficacy. The evidence of safety and efficacy will be shown by comparing the laboratory parameters at the end of the trial, with the pre-trial parameters.
As part of our preparations for the clinical trial we have already signed an agreement to manufacture Zygosid-50 with one of the more experienced companies in this field and the manufacturing process is underway.
Concomitantly, we are developing the analytical methods to quantify the blood level of the active component in the plasma of the trial participants, to allow correlation of the clinical effect with the dosage given.
Following an initiation visit with the team at SHEBA (mid-March), the SHEBA team will screen potential candidates and recruit the participants, so that the "First in Man" injection will take place during April.