Primary and Secondary Endpoints Achieved with Statistical Significance

Mizagliflozin Treatment Improves Glucose Nadir, Peak Glucose, Peak Insulin, and Level 3 and Level 2 Hypoglycemic Events

DURHAM, NC / ACCESSWIRE / June 26, 2024 / Vogenx, a clinical-stage developer of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases, today announced positive results from study VGX 001-012 evaluating Mizagliflozin in patients diagnosed with post-bariatric hypoglycemia (PBH).

Mizagliflozin is an investigational first-in-class, oral, small molecule drug candidate that reduces postprandial glucose absorption and secretion of insulin and gastric inhibitory peptide, also known as glucose-dependent insulinotropic peptide (GIP). Through this mechanism, mizagliflozin has demonstrated statistically significant improvements in postprandial peak glucose and glucose nadir while reducing secretion of insulin and GIP, thereby reducing postprandial reactive hypoglycemia in patients diagnosed with PBH.

The multicenter, randomized, single-blind, placebo-controlled, dose-ranging and regimen-finding study enrolled 15 patients actively struggling with symptoms of PBH. Each patient was dosed with two doses of mizagliflozin and placebo, each for seven days (21-day study period) with a one-week washout period between regimens. Mixed meal tolerance tests were administered at the conclusion of each treatment period, and all patients wore blinded continuous glucose monitors throughout each treatment period. For additional clinical trial information, please refer to www.clinicaltrials.gov.

The primary endpoints were safety and change in glucose nadir from placebo. Secondary endpoints included change from placebo peak plasma glucose and peak insulin.

In patients experiencing hypoglycemia (<70 mg/dL) on placebo, the change from placebo mean glucose nadir for the 5.0 and 10.0 mg doses combined (the highest doses examined) was 18.0 ± 7.75 mg/dL (p = 0.028; n=9); patients with placebo glucose nadir ≥70 mg/dL showed a change from placebo mean glucose nadir for the 5.0 and 10.0 mg doses of -7.97 ± 6.22 mg/dL (p = 0.24; n=9). These data suggest mizagliflozin is effective in preventing hypoglycemic events without significantly impacting blood glucose levels in patients not experiencing hypoglycemia.

The mean peak glucose changes from placebo for the 5.0 and 10.0 mg doses was ‑57.6 ± ‑47.2 mg/dL (p = 0.004; n=9). The mean peak insulin change from placebo for the 5.0 and 10.0 mg doses was -156.5 ± -89.5 uU/ml (p = 0.074; n=9). In the exploratory analysis, mizagliflozin showed significant reductions of Level 3 hypoglycemia, ‑0.27 (p=0.023) and -0.29 (p=0.07) events/day versus placebo for the 5 and 10 mg dose, respectively. Combined 5 and 10 mg showed a reduction of ‑0.26 (p=0.003) events/day versus placebo. Additionally, 5 and 10 mg doses exhibited a 30.3% and 75.5% reduction in Level 2 hypoglycemic events from placebo as measured by blinded CGM.

"We are very pleased by the results from Study 012," said William Wilkison, Ph.D., Chief Scientific Officer at Vogenx. "Mizagliflozin treatment consistently led to clinically meaningful improvements in both glucose and insulin while demonstrating significant effects on Level 3 and Level 2 hypoglycemic events. We look forward to continuing the development of mizagliflozin as a treatment for PBH."

Mizagliflozin was well-tolerated, with no drug-related serious adverse events or participant withdrawals. The most common adverse event was diarrhea which was considered mild to moderate.

About Mizagliflozin

Mizagliflozin is an investigational first-in-class, oral, small molecule drug candidate that reduces postprandial glucose absorption, secretion of insulin, and secretion of gastric inhibitory peptide, also known as glucose-dependent insulinotropic peptide (GIP). The molecule is being developed by Vogenx for the treatment of PBH and gastroparesis, both debilitating diseases with high unmet medical need in underserved patient populations. Mizagliflozin has been administered to over 500 subjects in clinical studies and has shown statistically significant reductions in postprandial glucose absorption as well as secretion of insulin and GIP.

About Post-Bariatric Hypoglycemia

PBH is an increasingly recognized chronic side effect of bariatric surgeries that are commonly performed as a treatment for obesity and related comorbidities. Neuroglycopenic symptoms can include shakiness, dizziness, confusion, sweating and loss of consciousness. These symptoms can be debilitating with a significant negative impact on quality of life, can dangerously impair normal day-to-day activities and can be life-threatening.

Bariatric surgery has proven to be the most effective treatment for severe obesity, leading to significant improvements in body mass index and obesity-related co-morbidities. It is estimated that over 9% of the U.S. population has a body mass index above 40 which is considered severely obese. With over 250,000 bariatric surgery procedures performed per year in the United States, postoperative prevalence of hypoglycemia symptoms in bariatric surgery patients is thought to be as high as 38.5%. There are currently no therapeutics approved by the FDA for the treatment of PBH.

About Vogenx, Inc.

Vogenx, Inc. is a clinical-stage life science company based in Durham, North Carolina. Vogenx is focused on the development of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases with high unmet medical need. The company is developing Mizagliflozin for post bariatric hypoglycemia and gastroparesis. For more information about Vogenx, please visit https://vogenx.com.

For more information:

+1 919.659.5677
info@vogenx.com

SOURCE: Vogenx, Inc