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, today 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 delivered LANCL2 agonist, for the treatment of rheumatoid arthritis (RA). The FDA has recently cleared an IND application for LABP-104 for the treatment of systemic lupus erythematosus (SLE). Landos has initiated a Phase 1 trial of LABP-104 for the treatment of RA and SLE in healthy volunteers and expects to report topline results in the first half of 2022.
“Our team continues to successfully and timely deliver on the goals we set out at the beginning of the year, notably to clear three INDs in 2021. The FDA clearance of the LABP-104 IND application in RA is Landos’ seventh successful IND approval derived from our LANCE A.I. platform in less than four years,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “LABP-104 has reduced inflammatory cell infiltration and its LANCL2 mechanism showed significantly less risk for toxicities than biologic and JAK inhibitor treatments currently available. As RA patients are prone to relapse, we are inspired by the opportunity to develop a candidate that could potentially redefine the treatment paradigm as a therapy that helps maintain clinical remission and overall survival for these patients, while improving their quality of life.”