LABP - Landos gets FDA greenlight for LABP-104 rheumatoid arthritis trial

Landos Biopharma (NASDAQ:LABP) announces that the U.S. 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). 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. 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). The primary endpoint will measure the safety and tolerability of LABP-104, while secondary endpoint will measure the pharmacokinetics of LABP-104. Shares up more than 2% premarket.

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Landos gets FDA greenlight for LABP-104 rheumatoid arthritis trial