Vogenx Announces Initiation of Phase 2 Clinical Study of Mizagliflozin for Post Bariatric Hypoglycemia
DURHAM, N.C., September 13, 2022, Vogenx Inc. – Vogenx, a clinical-stage developer of novel therapeutics for the treatment of metabolic disease, announced the screening of the first patient in a Phase 2 clinical study of mizagliflozin for the treatment of post bariatric hypoglycemia (“PBH”).
Mizagliflozin is a novel small molecule therapeutic candidate being developed for PBH. Mizagliflozin has been administered in over 500 subjects in 9 clinical trials and has shown to reduce and delay postprandial glucose absorption and insulin secretion. This Phase 2 randomized, sequential crossover single ascending dose study will evaluate mizagliflozin in patients diagnosed with PBH (NCT05541939). The study will examine four doses of mizagliflozin in patients randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).
Bill Wilkison, Vogenx Chief Scientific Officer, “In previous clinical studies, mizagliflozin has demonstrated a measurable reduction and delay in both glucose absorption and insulin secretion, two important variables for controlling PBH and hypoglycemic events in this patient population.” Wilkison continued, “PBH is an area of high unmet medical need and we are optimistic that mizagliflozin can deliver substantial improvements in quality of life to patients suffering from PBH.”
PBH is known to be 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 hypoglycemia that often presents 6 months to 4 years post-surgery. Hypoglycemic events in patients diagnosed with PBH are caused by rapid increases in postprandial circulating glucose and a corresponding uncontrolled spike 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.
About Vogenx, Inc.
Vogenx 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 metabolic diseases with high unmet medical need. For more information about Vogenx, please visit https://vogenx.com
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