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Ligand OmniAb® Partner Immunovant Announced Positive Topline Results from Multicenter, Placebo-Controlled Phase 2a Trial of IMVT-1401 in Myasthenia Gravis
IMVT-1401 is a novel anti-FcRn OmniAb-derived antibody delivered by subcutaneous injection Registration-enabling Phase 3 trial expected to initiate in the
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"\nIMVT-1401 is a novel anti-FcRn OmniAb-derived antibody delivered by subcutaneous injection\n\n\nRegistration-enabling Phase 3 trial expected to initiate in the first half of 2021\n\n SAN DIEGO--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (NASDAQ: LGND) OmniAb® partner Immunovant, Inc. (NASDAQ: IMVT) announced positive topline results from ASCEND MG, a Phase 2a study of OmniAb-derived IMVT-1401 in patients with myasthenia gravis (MG). Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.\n\n\nHighlights of the ASCEND MG trial include:\n\n\n\n3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale was statistically significant vs. placebo (p=0.029)\n\n\n8.0-point mean improvement on Myasthenia Gravis Composite (MGC) scale was highly statistically significant vs. placebo (p=0.006)\n\n\nMean reductions in total IgG from baseline for the 340 mg and 680 mg cohorts were 59% and 76%, respectively\n\n\nIMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs) and no withdrawals due to adverse events (AEs)\n\n\n\nImmunovant held a conference call to discuss ASCEND MG earlier today, and a replay of the webcast is available here.\n\n\n“We are proud of the ongoing work by Immunovant and the strong results demonstrated by IMVT-1401 in patients who suffer with myasthenia gravis. Importantly, IMVT-1401 holds potential to be a significant advancement in treatment for the approximately 65,000 myasthenia gravis patients in the U.S., should it be approved,” said John Higgins, Chief Executive Officer of Ligand. “Immunovant’s trial data follows positive Phase 3 results by CStone Pharmaceuticals earlier this month for their OmniAb program, where CStone announced a 50% reduction in the risk of disease progression or death for patients in their non-small cell lung cancer trial. OmniAb is a major antibody discovery platform and a key value-driver for Ligand. The positive clinical events are mounting for our proprietary platform, which is laying the potential for new drugs to be approved and generate royalties for Ligand. We have a growing OmniAb partner base with an increasing number of late-stage programs with important upcoming clinical or regulatory events.”\n\n\nASCEND MG was a multic...