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Prices via Intrinio. Supplier and customer ties are extracted from SEC filings and carry the sentence they came from. Not investment advice.
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We are a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies for the treatment of serious diseases associated with dysfunctions in human metabolism, including post-bariatric hypoglycemia, or PBH, and gastroparesis. Our company was founded in 2021 by experienced leaders with proven expertise developing drugs in the metabolic disease space. Our primary objective is to advance our lead investigational product candidate, mizagliflozin, a selective inhibitor of the sodium-glucose transporter 1, or SGLT1, through clinical development for disorders related to glucose absorption and postprandial dysregulation, and towards regulatory approval. Our lead product candidate, mizagliflozin, is an orally administered, minimally absorbed small molecule drug candidate in development for the treatment of PBH, gastroparesis, and GIP-dependent Cushing’s Syndrome, or GDCS. Mizagliflozin is a selective inhibitor of SGLT1, a glucose transporter present in the gastrointestinal tract responsible for transporting dietary glucose into the bloodstream. Mizagliflozin was discovered by Kissei Pharmaceutical Co., Ltd., or Kissei, and, in 2021, we obtained exclusive rights to mizagliflozin on a worldwide basis, excluding Japan, Korea and Taiwan, in exchange for certain milestone payments and royalties on net sales for any product candidates or commercial products associated with the licensed Kissei patents and know-how. To date, mizagliflozin has been administered to over 500 subjects in 10 clinical studies. Glucose absorption, and insulin and glucose-dependent insulinotropic polypeptide, or GIP, secretion were measured in six of these clinical studies. In each of the six studies, participants dosed with mizagliflozin were observed to have reduced and delayed postprandial glucose absorption and lowered overproduction of insulin and GIP when compared to participants dosed with placebo or as compared to baseline. These six clinical trials included studies VGX-001-011 and VGX-001-012, which involved a total of 24 patients diagnosed with PBH, D7101049 [healthy volunteers], D7101051 [healthy volunteers], SGA112534 [type 2 diabetics], and KWA1205 [chronic idiopathic constipation patients]. We have completed two Phase 2 clinical studies for mizagliflozin in patients diagnosed with PBH, in which a statistically significant reduction in postprandial glucose absorption and insulin secretion, as well as an improvement in both glucose nadir and glucose peak, was observed in the patients dosed with mizagliflozin versus those dosed with placebo or compared to baseline. Statistical significance is indicated by the p-value associated with the particular result. The term “p-value” represents the probability that random chance caused the result (e.g., a p-value=0.01 means that there is a 1% probability that the difference between the control group and the treatment group is purely due to random chance). Generally, a p-value less than 0.05 is considered statistically significant. Study results have also shown reductions in Level 3 and Level 2 hypoglycemic events in PBH patients dosed with mizagliflozin compared to placebo. We have begun study startup activities for our Phase 2b EMERGE study for the PBH program and expect to begin screening patients in 2026. We are also planning a Phase 2 proof of concept clinical trial of mizagliflozin in patients diagnosed with gastroparesis, which we plan to initiate in 2027. In addition, we anticipate submitting an IND to the U.S. Food and Drug Administration, or the FDA, in 2027 for use of mizagliflozin in patients diagnosed with GDCS. Our preclinical small molecule candidate, VGX-2857, is being considered for metabolic disease indications, including weight maintenance. We were founded as Vogenx, Inc., a Delaware corporation, on February 5, 2021. Our principal executive offices are located in Raleigh, North Carolina.
No institutional manager reports a position in this company. Funds disclose holdings quarterly on form 13F, and none of them names it.
Vogenx, Inc.
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Nasdaq · Manufacturing
Prev close 33.28 · gapped below the open, never looked back. High/low 33.00 at 9:15 am ET, 31.86 at 3:00 pm ET.
VOGX (Vogenx, Inc.) has 1 disclosed suppliers and 0 disclosed customers, strongest disclosure first.
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