A New Approach to Type 2 Diabetes

We are focused on transforming the treatment of metabolic diseases to improve the lives of patients.

Type 2 diabetes (T2D) is a progressive metabolic disease. This means that the disease affects how the body turns food into energy and disrupts the ability of the body to set (regulate) the correct levels of sugar in the blood. Blood sugar that rises and is not controlled over a long period of time can lead to life-threatening problems, including heart disease, kidney disease, and nerve damage.

Traditionally, T2D treatments have focused on managing the symptoms of the disease, such as increased blood sugar. But treating the symptoms alone does not prevent the disease from getting steadily worse. Because T2D keeps progressing, many patients require more medications to be added over time as they try to control their blood sugar, and, eventually, they may even require insulin therapy to treat rising blood sugar.

We believe that new approaches are needed to address T2D. Our goal is to treat the cause of diabetes, which we believe is in the gut (the duodenum), rather than trying to manage the symptoms. These will continue to get worse even if patients take their medications. We believe that the products we are developing, if approved, have the potential to keep the disease from progressing and can potentially minimize or eliminate the need for medications which are so difficult for patients and their families to manage.

Insulin therapy is very effective at lowering blood sugar in clinical trials but poses significant challenges for patients as a sustainable therapy. Only 30% of patients achieve good glycemic control even after long-acting insulin is added to their regime of other medicines. Insulin has several problems that prevent it from being more effective for patients, such as significant side effects, high burden of insulin medical management, increasing need for insulin as T2D worsens, and escalating cost.

We believe there is a significant unmet need for therapies that offer the potential to reduce daily disease management, particularly with insulin. We are seeking to create new therapies that aim to interrupt the progression of disease, are easy to administer, and can be easy to access

Dr. Rajagopalan on why alternatives to insulin are desperately needed

We are now enrolling patients with type 2 diabetes for our Revitalize 1 clinical study (NCT #04419779). Revitalize 1 is a pivotal clinical study of Revita^® in patients with inadequately controlled T2D despite taking insulin and multiple blood glucose lowering agents.

Revitalize 1 is a prospective, randomized, double-blind, crossover, sham-controlled study that is expected to enroll more than 900 patients across sites in the United States and Europe.