Vogenx, Inc. (NASDAQ:VOGX) has announced the initiation of EMERGE (VGX-001-013), a Phase 2b clinical study assessing mizagliflozin in adults with recurrent post-bariatric hypoglycemia. The randomized, double-blind, placebo-controlled trial will examine two doses of the investigational treatment.
#Study design and treatment groups
EMERGE is designed to enrol approximately 36 adults who underwent bariatric surgery more than 12 months before joining the study and experience recurrent reactive hypoglycemia.
Following a three-week run-in period, participants will be assigned to receive mizagliflozin 5 mg, mizagliflozin 10 mg or placebo. Treatment will be taken orally three times daily for 28 days.
The study will assess safety, tolerability and the treatment's effect on hypoglycemia. Glucose levels will be monitored continuously during the treatment period, with the primary endpoint defined as the number of combined Level 2 and Level 3 hypoglycemic events.
Vogenx expects the trial to take place at approximately 10 sites in the United States. The study is registered under ClinicalTrials.gov identifier NCT07760961.
#Mizagliflozin development programme
Vogenx describes mizagliflozin as an investigational, orally administered, minimally absorbed small-molecule inhibitor of sodium-dependent glucose transporter 1, or SGLT1. The company says the compound is designed to act in the small intestine by reducing and delaying dietary glucose absorption.
The company is developing mizagliflozin for post-bariatric hypoglycemia, gastroparesis and GIP-dependent Cushing's Syndrome. Vogenx said the compound has been administered to more than 500 subjects across 10 clinical studies and has shown reductions in postprandial glucose absorption, GIP secretion and insulin secretion. It also reported improvements in postprandial glucose nadir and Level 2 and Level 3 hypoglycemia events among patients diagnosed with post-bariatric hypoglycemia.
Vogenx said earlier clinical studies found mizagliflozin to be well tolerated, with no drug-related serious adverse events and no discontinuations or withdrawals. The company's risk disclosures state that results from earlier studies may not predict outcomes in later studies.
#Post-bariatric hypoglycemia context
Post-bariatric hypoglycemia is described by Vogenx as a chronic complication associated with bariatric surgery. Episodes can occur after meals and may involve shakiness, dizziness, confusion, sweating or loss of consciousness. The company said the condition can affect daily activities and may be life-threatening.
Vogenx also said there are currently no therapeutics approved by the U.S. Food and Drug Administration for the treatment of post-bariatric hypoglycemia.
#Risks and development uncertainties
Vogenx identified risks related to the initiation, timing, enrolment and results of clinical trials, as well as regulatory review and reliance on clinical research organisations and trial sites. The company also cited its licence from Kissei Pharmaceutical Co., Ltd., the need for additional capital, its limited operating history and dependence on a small number of key personnel.
The company said statements concerning the EMERGE study's conduct, enrolment, timing and results are subject to risks and uncertainties. It also said forward-looking statements speak only as of the date of the announcement and that it undertakes no obligation to update them except as required by law.
#About Vogenx
Vogenx is a clinical-stage biopharmaceutical company based in Raleigh, North Carolina. It focuses on developing therapeutics for serious metabolic and gastrointestinal diseases and is advancing mizagliflozin across its stated development areas.
#Key Takeaways
- Vogenx has initiated the Phase 2b EMERGE study of mizagliflozin for post-bariatric hypoglycemia.
- The trial is designed to enrol approximately 36 adults who underwent bariatric surgery more than 12 months earlier and experience recurrent reactive hypoglycemia.
- Participants will receive mizagliflozin 5 mg, mizagliflozin 10 mg or placebo three times daily for 28 days after a three-week run-in period.
- The primary endpoint is the number of combined Level 2 and Level 3 hypoglycemic events, supported by continuous glucose monitoring.
- Vogenx identified clinical, regulatory, funding and operational risks affecting the programme.
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