Vogenx Completes Dosing of Last Patient in Phase 2 Clinical Study of Mizagliflozin for the Treatment of Post-Bariatric Hypoglycemia
- Topline results expected summer of 2024
DURHAM, NC / ACCESSWIRE / April 2, 2024 / Vogenx, Inc., a clinical-stage developer of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases, today announced that it has completed dosing of the last patient in its Phase 2 clinical 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 (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 Company expects topline data from this study to be available summer of 2024.
“We are pleased to announce that we have dosed the last patient in our Phase 2 clinical trial evaluating mizagliflozin in patients with PBH,” said James Green, Vogenx chief executive officer. “With no currently approved therapeutics, PBH is increasingly becoming a large, underserved market where patients are inadequately relieved of their symptoms. We are encouraged by what we continue to learn from our participating patients and believe that mizagliflozin has the potential to become an effective and well-tolerated therapeutic option for patients suffering from PBH.”
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 (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.
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