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Thu. 28 Oct 2021, 7:35am ETBenzinga
In: Biotech, News, FDA, General

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 the Company has dosed the first subject in a Phase 1 study of LABP-104, a potentially first-in-class oral, small-molecule LANCL2 agonist, for the treatment of systemic lupus erythematosus (SLE).

“We are pleased to announce the initiation of the first clinical trial investigating LABP-104, marking Landos’ sixth novel clinical program addressing the unmet clinical needs of patients with autoimmune diseases,” said Dr. Josep Bassaganya-Riera, Chairman, President, and CEO of Landos. “Our LANCE platform coupled with our agile entrepreneurial culture continues to deliver high value shots on goal. There are approximately 1.5 million patients in the U.S. suffering from SLE with very limited therapeutic options. Leveraging our LANCE platform to develop a proprietary LABP-104 transcriptional response signature in blood holds promise to identify the SLE patients that may benefit the most from oral LABP-104 treatment. We are excited to advance LABP-104 as the first potential precision medicine-based therapeutic candidate for SLE into clinical testing.”

The 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 seven days in the MAD. The primary endpoint will measure the safety and tolerability of LABP-104. Secondary endpoint will measure the pharmacokinetics of LABP-104. We expect to report topline results of the Phase 1 trial in the first half of 2022.  Additional information about the Phase 1 LABP-104 trial is available at clinicaltrials.gov (NCT050​19950).

By using the LANCE® Advanced A.I. platform, Landos has developed a 15-gene LABP-104 transcriptional response signature in whole blood that could be used as a companion diagnostic to better characterize the subsets of lupus patients that can benefit the most from oral treatment with LABP-104. This precision medicine signature will be further validated as an exploratory endpoint in Phase 1 and 2 SLE studies.