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MediciNova Announces Completion of Last Patient Last Visit in the MN-001-NATG-202 Clinical Trial of MN-001 (Tipelukast)

  • MediciNova, Inc. completed the last patient last visit (LPLV) in its Phase 2 trial MN-001-NATG-202 evaluating MN-001 (tipelukast) for hypertriglyceridemia and NAFLD in patients with type 2 diabetes mellitus.
  • The multicenter, randomized, double-blind, placebo-controlled trial randomized patients 1:1 to receive 500 mg/day of MN-001 or placebo for 24 weeks.
  • Co-primary endpoints include the change from baseline in liver fat content (CAP score) and fasting serum triglycerides at Week 24, with secondary endpoints covering safety, tolerability, and lipid profile changes.
  • Top-line data for the study are expected in the third quarter of 2026.
  • MN-001 is a novel small-molecule compound with multiple mechanisms, including leukotriene receptor antagonism, phosphodiesterase inhibition, and 5-lipoxygenase inhibition to reduce inflammation \& fibrosis.
  • MN-001 down-regulates genes promoting fibrosis (LOXL2, Collagen Type 1, TIMP-1) \& inflammation (CCR2, MCP-1) while inhibiting triglyceride synthesis in hepatocytes.
  • The major metabolite MN-002 enhances cholesterol efflux in macrophages by upregulating ABCA1 \& ABCG1 transport proteins.
  • MediciNova has 11 clinical programs, including lead asset MN-166 (ibudilast) in Phase 3 for ALS \& DCM, with MN-001 also undergoing evaluation in a Phase 2 trial for idiopathic pulmonary fibrosis.