Vogenx initiates EMERGE study of Mizagliflozin for post-bariatric hypoglycaemia

Vogenx has initiated the EMERGE (VGX-001-013) study - its Phase 2b clinical trial evaluating mizagliflozin for the treatment of post-bariatric hypoglycaemia (PBH). There are currently no therapeutics approved by the FDA for the treatment of PBH.

EMERGE is a randomised, placebo-controlled, double-blind, parallel-group Phase 2b study designed to enrol approximately 36 adults who underwent bariatric surgery more than 12 months prior and who experience recurrent reactive hypoglycemia. Following a three-week run-in period, eligible participants will be randomized to receive mizagliflozin 5 mg, mizagliflozin 10 mg or placebo, taken orally three times daily for 28 days. The study will evaluate the safety and tolerability of mizagliflozin and its ability to reduce hypoglycemia, with glucose monitored continuously throughout treatment. Primary endpoint is the number of combined Level 2 and Level 3 hypoglycemic events. The trial is expected to be conducted at approximately 10 sites in the US.

"Initiating EMERGE is an important milestone for Vogenx and for people living with post-bariatric hypoglycemia, a serious and often debilitating condition with no approved treatment options," said James Green, Chief Executive Officer of Vogenx. "Mizagliflozin has been studied in more than 500 subjects across 10 clinical studies and has been shown to reduce Level 2 and Level 3 hypoglycaemic events in clinical studies of patients diagnosed with PBH. EMERGE is designed to build on those earlier results in a larger, placebo-controlled parallel group setting, and we look forward to working with our investigators to advance enrolment."

Mizagliflozin is an investigational, first-in-class, orally administered, minimally absorbed small molecule inhibitor of the sodium-dependent glucose transporter 1 (SGLT1). Unlike other SGLT inhibitors, which act systemically by blocking glucose reabsorption in the kidney, mizagliflozin is designed to act locally in the small intestine, with its effects limited to the intestinal lumen, where SGLT1 is the primary transporter responsible for dietary glucose absorption.

By reducing and delaying intestinal glucose absorption, mizagliflozin lowers postprandial glucose absorption and reduces secretion of insulin and gastric inhibitory peptide, also known as glucose-dependent insulinotropic peptide (GIP). The molecule is being developed by Vogenx for the treatment of PBH, gastroparesis and GIP-dependent Cushing's Syndrome. Mizagliflozin has been administered to more than 500 subjects in 10 clinical studies and has shown statistically significant reductions in postprandial glucose absorption, GIP secretion, and insulin secretion.

Mizagliflozin has also demonstrated improvement in postprandial glucose nadir as well as Level 2 and Level 3 hypoglycemia events in patients diagnosed with PBH. In clinical studies, mizagliflozin has been shown to be well tolerated with no drug-related serious adverse events and no discontinuations or withdrawals.

Additional information is available at ClinicalTrials.gov under identifier NCT07760961.