BROAD INFLAMMATION & IMMUNOLOGY PIPELINE OF CANDIDATES WITH NOVEL MECHANISMS

We’ve partnered with LianBio to develop and commercialize Omilancor and NX-13 in Greater China and select Asian markets

Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LANCL2
LANCL2
Omilancor (BT-11)
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
Omilancor (BT-11)Ulcerative Colitis
Ulcerative Colitis
Crohn's Disease
Crohn's Disease
Eosinophilic Esophagitis
Eosinophilic Esophagitis
Psoriasis
Psoriasis
Atopic dermatitis
Atopic dermatitis
LABP-104
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LABP-104Lupus
Lupus
Rheumatoid Arthritis
Rheumatoid Arthritis
LABP-111
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LABP-111NASH
NASH
Type 1 Diabetes
Type 1 Diabetes
NLRX1
NLRX1
NX-13
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
NX-13Ulcerative Colitis
Ulcerative Colitis
Crohn's Disease
Crohn's Disease
LABP-66
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LABP-66Multiple Sclerosis
Multiple Sclerosis
Alzheimer's Disease
Alzheimer's Disease
LABP-73
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LABP-73Asthma
Asthma
COPD
COPD
PLXDC2
PLXDC2
LABP-69
Pathway ProgramProg IndicationInd PreclinicalPre IND-EnablingIND Phase IPh I Phase IIPh II Phase IIIPh III
LABP-69Diabetic Nephropathy
Diabetic Nephropathy
Rheumatoid Arthritis
Rheumatoid Arthritis

Learn More About Our Clinical Candidates

Omilancor Exerts Anti-Inflammatory Effects Within the Gastrointestinal Tract

Omilancor (BT-11), our lead product candidate, is a first-in-class, gut-restricted oral therapeutic candidate that targets LANCL2, a membrane receptor that has been shown to modulate immunological mechanisms that are associated with various autoimmune diseases such as ulcerative colitis (UC) and Crohn’s disease (CD).

In 2021, Landos announced final results from its Phase 2 proof-of-concept trial of omilancor in patients with mild-to-moderate UC. The results demonstrated that omilancor was gut-restricted and well tolerated, with a similar adverse event profile across placebo and omilancor groups. In addition, omilancor induced placebo-adjusted clinical remission rates of up to 11.5% at week 12, with normalization of biomarkers such as fecal calprotectin observed after two weeks of oral dosing. Based on clinical data to date, omilancor may address the main limitations of current therapies by providing a convenient once a day dosing that offers low systemic exposure, improved tolerability and no ties to toxicities. Following a positive outcome from an End-of-Phase 2 meeting with the U.S. FDA, Landos and the FDA agreed on key elements necessary for regulatory approval.

BT-11, an oral LANCL2 agonist for the treatment of ulcerative colitis and Crohn’s disease
BT-11 triggers a signaling cascade that generates stable and suppressive regulatory CD4-positive T cells that are central to restoring and maintaining immune tolerance in the GI tract. In turn, BT-11 contributes to lower calprotectin biomarker levels and decreased epithelial damage in models of inflammatory bowel disease.

NX-13 Modulates Epithelial Integrity and Mucosal Immune Responses in the Gastrointestinal Tract

NX-13 is a first-in-class novel, gut-restricted oral therapeutic candidate that targets NLRX1 (NOD-like receptor X1), a mitochondria-associated receptor that has been associated with the modulation of inflammatory cytokines for UC and CD.

In March 2021, Landos reported positive results from a Phase 1a trial of NX-13 in healthy volunteers, for which all primary and secondary endpoints in safety and tolerability were achieved. In April 2021, Landos initiated a Phase 1b trial to evaluate the safety and pharmacokinetics of multiple dose levels of NX-13 in patients with UC.

NX-13, an oral NLRX1 agonist for the treatment of ulcerative colitis and Crohn’s disease
NX-13 targets the NLRX1 pathway to induce anti-inflammatory effects in CD4+ T cells and other immune cells in the gastrointestinal tract. As a result, NX-13 has the potential to modulate epithelial integrity, host-microbiome interactions and mucosal immune responses.

LABP-104 Aims to Enhance Tolerability and Restore Homeostasis in Immune Cells

LABP-104 is an oral, small molecule LANCL2 agonist in development for the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and other debilitating and widespread autoimmune diseases.

Patients with SLE commonly produce autoantibodies that result in inflammation and tissue damage. LANCL2 activation intercepts these events upstream through the induction of regulatory T cell (Treg) responses and support of metabolic requirements for autophagy. LABP-104 has reduced type I interferon signaling in human SLE patient peripheral blood mononuclear cells (PBMCs) in response to general, TLR and DNA antigens. In addition, oral treatment with LABP-104 maintained kidney function, reduced anti-nuclear antibody formation and shifted the balance of CD4+ T cells from effector or inflammatory subsets to protective Tregs in the spleen.

In animal models of RA, activation of the LANCL2 pathway has resulted in decreased tissue-damaging Th17 and Tfh cells with increased protective Tregs.

Landos initiated a Phase 1 trial of LABP-104 for the treatment of SLE and RA in healthy volunteers in October 2021, with topline data readout expected in the first half of 2022.

LABP-104 diagram
LABP-104 targets the LANCL2 pathway to increase anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. As a result, LABP-104 has the potential to restore the immune system to homeostasis and enhance mitochondrial metabolism.