DURHAM, N.C., August 1, 2023 – Vogenx, a clinical-stage developer of novel therapeutics for the treatment of rare and metabolic disease, announced today the initiation of a Phase 2 clinical study of mizagliflozin for the treatment of post-bariatric hypoglycemia (PBH). PBH is a debilitating complication of bariatric surgery leading to recurrent postprandial hypoglycemia with neuroglycopenia.
Mizagliflozin is a first-in-class, orally available small molecule inhibitor of the sodium-dependent glucose transporter-1 (SGLT-1) in Phase 2 clinical development for PBH. PBH is a disease with growing high unmet medical need and no approved pharmacologic therapy.
Study VGX 001-012 is a multicenter, randomized, single-blind, placebo-controlled, dose-ranging and regimen-finding trial in patients who suffer from 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 will be assessed in subjects during weekly dosing periods and during a mixed meal tolerance test. The first patient dosed in study VGX 001-012 was in July 2023; top line results are expected in 2024.
According to Bill Wilkison, Vogenx Chief Scientific Officer, “The results from study VGX 001-011 presented earlier this year proved our hypothesis that mizagliflozin can safely and effective treat postprandial hypoglycemia in PBH subjects; study 012 should provide us insight into appropriate doses to bring forward into later stage studies.” Wilkison continued, “Anecdotally, the feedback we are getting from our clinical sites is very promising.”
About Mizagliflozin
Mizagliflozin is a novel first in class small molecule therapeutic candidate being developed for PBH. Mizagliflozin has been administered to over 500 subjects in 9 clinical studies and has shown statistically significant reductions in postprandial glucose absorption and insulin secretion.
About Post-Bariatric Hypoglycemia
PBH is a side effect associated with bariatric surgeries that are commonly performed as a treatment for obesity. Bariatric surgery has proven to be a highly effective treatment for obesity, leading to significant improvements in body mass index and obesity-related co-morbidities. There are currently no therapeutics approved by the FDA for the treatment of PBH.
PBH is a form of reactive postprandial hyperinsulinemic hypoglycemia that presents 12 months to several years post-surgery. Hypoglycemic events in patients diagnosed with PBH result from rapid increases in postprandial circulating glucose and corresponding uncontrolled spikes in insulin, typically 1-2 hours after a meal. Symptoms may be mild, moderate or severe and can include those associated with neuroglycopenia such as shakiness, hunger, dizziness, confusion, sweating and loss of consciousness that can dangerously impair normal day-to-day activities and can be life-threatening. Severe PBH can be debilitating with a significant negative impact on quality of life.
About Vogenx, Inc.
Vogenx, Inc. is a clinical-stage life science company based in Durham, North Carolina. The Company is focused on the development of novel therapeutics for the treatment of diseases with unmet medical need. For more information about Vogenx, please visit https://vogenx.com
For more information:
+1 919.659.5677
SOURCE: Vogenx, Inc.