January 15, 2016
By Alex Keown, BioSpace.com Breaking News Staff
MARLBOROUGH, Mass. – Privately-held Theracos, Inc. raised $25 million to fund development of bexagliflozin, an experimental SGLT-2 inhibitor for the treatment of Type 2 diabetes, MedCityNews reported this morning.
SGLT2 is an acronym for sodium-glucose linked transporter 2, a membrane protein that acts as a portal for glucose into the cell. SGLT2 inhibitors have been found to be useful for the treatment of type 2 diabetes, Theracos said on its website. The company is currently recruiting patients for a Phase IIb dosing trial to study the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with Type 2 diabetes. A Phase II trial completed in 2014 showed bexagliflozin resulted in a statistically significant lowering of HbA1c over a 96-week course of treatment.
Type 2 diabetes affects 90 to 95 percent of the 26 million Americans diagnosed with diabetes. People with type 2 diabetes typically cannot make, or use the insulin their body produces, which allows glucose to enter the body’s cells, causing the cells to not act as designed. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
In May, federal regulators fired off a warning that sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to diabetic ketoacidosis requiring hospitalization. The FDA warning will have implications on Invokana, manufactured by Johnson & Johnson , dapagliflozin, also known as Farxiga, and combination drug Xigduo XR, dapagliflozin/metformin, both developed by AstraZeneca , empagliflozin, or Jardiance, and Glyxambi, both made by Eli Lilly and Germany-based Boehringer Ingelheim. The FDA said a search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. Each of the patients required hospitalization or emergency room treatments.
In its warning, the FDA said the SGLT2 inhibitors may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Diabetic ketoacidosis most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels, the FDA said. The FDA warned that patients taking these SGLT2 inhibitors should monitor themselves for any signs of ketoacidosis and “seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.”
