DiaVacs announced that the FDA has granted Orphan Drug designation to DV-0100 for type 1 diabetes (TD1M). DV-0100 works by halting the body’s autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease.
DV-0100 has been shown to be safe and effective in animal models of T1DM, and evidenced no safety signals in human Phase 1 trials in patients with established type 1 diabetes for five years or longer. In some patients in the Phase 1 human trial, production of endogenous insulin was measured, even after 10 years of disease. DiaVacs has initiated a Phase 2 human trial with DV-0100.
For more information visit DiaVacs.com.