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Tue. 2 Nov 2021, 8:29am ETBenzinga
In: News, FDA

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."

Like omilancor, Landos's Phase 3-ready therapeutic candidate for UC, LABP-104 targets the anti-inflammatory receptor LANCL2, a novel mechanism for enhancing Treg function and decreasing TNF production. In a collagen-induced mouse model of arthritis, oral treatment with LABP-104 provided protection from severity of disease, including a significant reduction of redness and swelling in addition to overall paw size. Consistent with the validated actions of the LANCL2 pathway in other indications, with once-daily oral dosing, LABP-104 significantly reduced the numbers of Th17 and T follicular helper cells in the spleen while increasing the number of CD25high FOXP3+ Tregs.

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 for SLE and RA is available at clinicaltrials.gov (NCT050​19950).