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We initiated a Phase IIb clinical trial on approximately 180 type 2 diabetic patients in approximately 30 sites in the United States, beginning in June 2015. This double-blind, randomized, 28-day study clinical trial is conducted under an Investigational New Drug application, or IND, with the U.S.
Food and Drug Administration, or FDA. The clinical trial is designed to assess the safety and efficacy of ORMD-0801, will investigate ORMD-0801 over a longer treatment period and will have statistical power to give us greater insight into the drugs efficacy. We anticipate that the last patient will complete this
trial during the first quarter of calendar year 2016.
We are also conducting a glucose clamp study of our oral insulin capsule on type 2 diabetic volunteers that will be performed at The University of
Texas Health Science Center at San Antonio and University Health Systems Texas Diabetes Institute. The glucose clamp is a method for quantifying insulin
absorption in order to measure a patients insulin sensitivity and how well a patient metabolizes glucose. As previously announced, the first patient has been
enrolled and we anticipate completing the study in the second quarter of calendar year 2016.
In September 2013, we submitted a pre-IND, package to the FDA, for ORMD-0901, our oral exenatide capsule, for a Phase 2 clinical trial on healthy
volunteers and type 2 diabetic patients. We began pre-clinical studies in November 2014 and expect to begin IND-enabling studies in the second quarter of
calendar year 2016. We then intend to file an IND and move immediately and directly into a large Phase II multi-center trial in the United States. In August
2015, we began a non-FDA approved clinical trial on type 2 diabetic patients, and we anticipate it will be completed during the first quarter of calendar year
2016.
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