Type 1 Diabetes

Type 1 Diabetes mellitus is one of the most rapidly growing diseases worldwide, and is a primary cause of excess cardiovascular, renal and visual morbidity and mortality in Western populations.   While life style modifications, including diet and insulin administration is employed to successfully control glycemic levels in diabetic patients, these options serve merely as a stop-gap; as even those patients with excellently monitored glucose levels will eventually develop some form of diabetes-associated complications, particularly cardiovascular morbidity.
 
Therefore, there is a need for a therapeutic approach that not only targets the symptoms of diabetes but also addresses the underlying cause of this disease.  Research has identified auto-reactive αβ T cells as the major cause of damage to insulin producing cells.  Further research has demonstrated that halting the disease by modulating T-cells can delay the onset of type 1 diabetes. 
 
The ability for TOL101 to target the specific auto-reactive T-cell subset and safely inactivate their response is likely to offer Type 1 diabetes sufferers a novel therapeutic option, reducing diabetes symptoms and improving quality of life.  Tolera plans to investigate the use of its TOL101 technology in novel therapeutic protocols addressing this unmet medical need.

In 2010, TOL101 received Orphan Drug Designation from the US Food and Drug Administration for treatment of recent onset immune-mediated Type 1 diabetes mellitus (T1DM) for patients 16 years and younger.