Loading MTVA…
MTVA • CIK 0001638287
Overview We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity. ● Vanoglipel (DA-1241) is a novel GPR119 (“GPR119”) agonist with development optionality as a standalone or combination therapy for both MASH and Type 2 Diabetes Mellitus (“ T2DM”). Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide-1 (“ GLP-1”), glucagon-dependent insulinotropic polypeptide receptor (“GIP”), and peptide YY (“PYY”) . These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel (DA-1241) has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies. o In Phase 1a and 1b human clinical trials, vanoglipel (DA-1241) was well tolerated in both healthy volunteers and those with T2DM. o We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel (DA-1241) in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel (DA-1241). In November 2024, we completed the last patient last visit for the Phase 2a clinical trial. o In December 2024, we an nounced positive topline 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. o In May 2025, we presented the topline 16-week results from the two-part Phase 2a clinical trial at the European Association for the Study of the Liver (“EASL”) 2025. o In November 2025, we presented sub-group analysis on glucose control in prediabetes and diabetes subjects and additional data on inflammation and lipidomic profiles at the American Association for the Study of Liver Diseases (“AASLD”) The Liver Meeting ® 2025. o We are expecting to finalize the Clinical Study Report (“ CSR”) of the Phase 2a clinical trial in the first half of 2026. ● DA-1726 is a novel oxyntomodulin (“OXM”) analog functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously. With the activation of the dual agonist, weight loss may be achieved by GLP1R reducing appetite while GCGR increases energy expenditure. o DA-1726 has a well understood mechanism and, in preclinical mice models, resulted in improved weight loss compared to semaglutide and tirzepatide. o We initiated a Phase 1 clinical trial in 2024 with the goal of establishing the safety and tolerability of DA-1726 while exploring the mechanism of action and efficacy of DA-1726 in the treatment of obesity. This is the first-in-human clinical trial for DA-1726. o In September 2024, we announced positive topline data from the single ascending dose (“ SAD ”) Part 1 of our Phase 1 clinical trial evaluating DA-1726 while an additional SAD study and a multiple-ascending dose (“ MAD”) study were ongoing . Overall safety and tolerability in Part 1 of the Phase 1 clinical trial was clean and allowed us to continue the MAD Part 2 of the Phase 1 clinical trial . o In April 2025, we announced positive topline data from our up to 32 mg, MAD cohort Part 2 of the Phase 1 clinical trial. o In June 2025, we began enrollment for a higher-dose MAD cohort to assess the maximum tolerated dose and fully realize DA-1726’s potential, as higher doses may also show a similar profile, while potentially demonstrating increased weight reduction. We dosed the first patient in the non-titrated 48 mg, MAD cohort of our Phase 1 clinical trial in July 2025, and we extended the clinical trial for this 48 mg, MAD cohort to eight weeks from four weeks to further explore the non-titrated maximum tolerated dose, explore safety and 5 Table of Contents other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy.…
From recent Form 4 filings