"First-In-Man Clinical Trial – Zygosid-50 for treating T2D" - summary of results (partial)
The primary efficacy objective of the study was to demonstrate that treatment with Zygosid-50 yields a significant reduction in the average daily blood glucose level (BGL). Blood glucose levels were self-monitored daily, including 7 consecutive Self Blood Glucose Measurements (SBGM) at week #1, week #6 and week #12. Also, continuous glucose-level monitoring (CGM) was performed at weeks 1-2 and 11-12 (end) of the study.
SBGM was performed at the following times each day – after fasting (wake-up); 2 hours following breakfast; before lunch; 2 hours after lunch; before dinner; 2 hours following dinner; before sleep.
Secondary efficacy objectives of the study were to (i) reduce HbA1c levels at week 12, by 0.3% or more, compared to its value at the start of the trial, and (ii) to reduce the insulin resistance in T2DM patients, as determined by HOMA-IR, by comparing the parameters of blood glucose levels (BGL) and blood insulin level, after fasting, at time 0 and end of week #12.
Summary of results for first three participants recruited (males, 45-55 y.o.) are presented herein. All three participants complained of burning sensation at the sub-cutaneous injection site, lasting for a few hours each time, accompanied by the formation of subcutaneous nodules, palpable for a number of days, with transient superficial reddening of the skin over the injection site. Two participants prematurely terminated their participation in the trial while the third completed 12 weeks of treatment, yet with a daily dose of 0.5 mg/kg, far less than the initial target dose (of 3 mg/kg), because of constant pain at injection site – therefore not escalating the dose in order to limit the injected volume – presumably a major cause of the pain. None of the participants experienced any systemic clinical adverse events throughout the duration of the trial.
The main diabetes-related parameters of the three patients before and after the treatment with Zygosid-50 are summarized in the table below.
The positive results presented demonstrate improvements in the endpoints, albeit partial data.
In order to overcome the injection-site-pains (the actual ability to conduct the trial - recruitment and participation of patients), other constraints, and the logistics involved in using injections as the route of administration, as well as lowering the cost of production/logistics and extending the shelf life of the drug, a series of animal experiments are now in the final stages. These trials will enable production of an oral dose (pill) to be used in a follow up clinical trial to the Sub-Cu injection trial.