DURHAM, NC / ACCESSWIRE / February 15, 2024 / Vogenx, Inc., a clinical-stage developer of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases, today announced completion of patient enrollment of a mid-Phase 2 clinical dose ranging study (VGX-001-012) evaluating Mizagliflozin in patients diagnosed with post-bariatric hypoglycemia (PBH).
"Completing enrollment of this study is a significant step forward as we look to advance mizagliflozin as a first in class treatment to help patients better manage their symptoms and the daily challenges they present," said Vogenx Chief Scientific Officer Bill Wilkison. "We look forward to seeing the data from study 012 and are thankful for the high level of engagement from our study investigators, their staff, and our patient participants who are all committed to making this study a success."
Study VGX 001-012 is a multicenter, randomized, single-blind, placebo-controlled, dose-ranging and regimen-finding trial in patients diagnosed with PBH (NCT05721729). The study is designed to identify dose strengths and frequency of dosing to be administered in future clinical studies. Tolerability, safety and pharmacodynamic response to mizagliflozin is assessed in subjects during weekly dosing periods and during a mixed meal tolerance test.
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. Symptoms can include neuroglycopenia, shakiness, hunger, 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. 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 Mizagliflozin
Mizagliflozin is a novel first in class small molecule therapeutic candidate being developed for PBH and gastroparesis. Mizagliflozin has been administered to over 500 subjects in clinical studies and has shown statistically significant reductions in postprandial glucose absorption, insulin secretion, and GIP.
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
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SOURCE: Vogenx, Inc.