Clinical Pipeline

BROAD INFLAMMATION & IMMUNOLOGY PIPELINE OF CANDIDATES WITH NOVEL MECHANISMS

We own worldwide development and commercialization rights to each of our product candidates.

PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LANCL2
LANCL2
Omilancor (BT-11)
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase 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
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LABP-104Lupus
Lupus
Rheumatoid Arthritis
Rheumatoid Arthritis
LABP-111
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LABP-111NASH
NASH
Type 1 Diabetes
Type 1 Diabetes
NLRX1
NLRX1
NX-13
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
NX-13Ulcerative Colitis
Ulcerative Colitis
Crohn's Disease
Crohn's Disease
LABP-66
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LABP-66Multiple Sclerosis
Multiple Sclerosis
Alzheimer's Disease
Alzheimer's Disease
LABP-73
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LABP-73Asthma
Asthma
COPD
COPD
PLXDC2
PLXDC2
LABP-69
PathwayProgramProgIndicationIndPreclinicalPreIND-EnablingINDPhase IPh IPhase IIPh IIPhase IIIPh III
LABP-69Diabetic Nephropathy
Diabetic Nephropathy
Rheumatoid Arthritis
Rheumatoid Arthritis

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.

Additionally, Landos initiated a Phase 2 trial in May 2021 to evaluate proof-of-concept efficacy and safety of omilancor in patients affected by moderate-to-severe CD. Landos also expects to initiate a Phase 1b trial of omilancor in a third indication, Eosinophilic Esophagitis (EoE), in the first half of 2022.

BT-11 Diagram

Reprogramming Immune Responses in Autoimmune Diseases

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 Diagram

NX-13