Landos Biopharma, Inc. (NASDAQ: LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for LABP-104, a novel, oral, systemically distributed LANCL2 agonist, for the treatment of systemic lupus erythematosus (SLE). Landos plans to initiate a Phase 1 trial in healthy volunteers before yearend and report topline results in the first half of 2022.
“Building on our early success with omilancor in gastrointestinal and topical indications, our LANCE platform continues to deliver novel oral, small-molecule therapeutics for patients with autoimmune diseases. The FDA clearance of the LABP-104 IND application in SLE is Landos’ sixth successful IND approval in less than four years and demonstrates our commitment to developing safer and more effective first-in-class therapeutics for these patients,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “SLE is an often misdiagnosed and potentially terminal disease, primarily impacting women of child-bearing age, characterized by multiple organ failures when the immune system turns on itself. There is no cure for SLE and, given that current treatment regimens rely on potent immunosuppressants that pose debilitating side effects, we are highly motivated to leverage our deep understanding of the LANCL2 pathway to develop LABP-104 as a differentiated, oral, once-daily therapeutic option for these patients.”
LABP-104 activates the LANCL2 pathway to restore the immune system to homeostasis through the enhancement of regulatory T cell (Treg) function and increasing mitochondrial metabolism. In preclinical and translational studies, LABP-104 reduced interferon gamma signaling in human SLE patient peripheral blood mononuclear cells (PBMCs) in response to TLR7 and DNA antigens. Additionally, oral treatment with LABP-104 prevented the worsening of proteinuria and reduced anti-nuclear antibody levels by three-fold. Overall, oral LABP-104 treatment demonstrated reduced kidney tissue damage and statistically significant therapeutic efficacy in mouse models of lupus. Mechanistically, the clinical and histological improvements significantly reduced effector, tissue-damaging IL-17- and IL-21-producing CD4+ T cells in the spleen while significantly increasing protective Tregs.
The planned Phase 1 trial is a randomized, placebo-controlled, double-blind, ascending dose, multi-cohort study designed to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. A total of 56 healthy volunteers will be enrolled in two parts – a single ascending dose study (SAD) and then a multiple ascending dose study (MAD), during which the participants will be randomized to five cohorts receiving single oral doses of LABP-104 or placebo in the SAD, and to three cohorts receiving three oral doses of LABP-104 or placebo once daily for 7 days in the MAD. The primary endpoint will measure the safety and tolerability of LABP-104. The secondary endpoint will measure the pharmacokinetics of the once-daily oral therapeutic.