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BT-11: An Investigational Oral First-In-Class Therapeutic for IBD

Expansible Therapeutic Pipeline

BT-11: An Investigational Oral First-in-class Therapeutic for IBD

Inflammatory bowel disease (IBD) afflicts 1.6 million Americans and 4 million people worldwide. It is an autoimmune disease of the gastrointestinal tract associated with inflammation of the lining of the digestive tract, which can lead to flare-ups. For patients with IBD, inflammation is at the root of their symptoms.

While the exact cause of IBD remains unknown, researchers now believe that a combination of genetics, environmental factors and an abnormal immune response to the gut microbiota may result in damaging inflammation of the digestive tract. Abdominal pain and cramping are two of the many IBD symptoms.

Problems with Current Treatment Expensive, Risky and not that Effective

The current treatment paradigm for IBD depends upon the severity of the disease. Landos technology has the potential to change the current paradigm for moderate-to-severe cases, and it is potentially steroid and anti-TNF-a biologic sparing.

1. Treatments are expensive: Current cost for anti-TNF-a treatment ranges from $40,000 to $50,000 per patient per year.

2. Treatments are modestly successful: 5-ASA can only be used on mild cases of inflammation, and the anti-TNF-a technology only works between 40-60% of the patients.

3. Treatments have undesired side effects: Continuous treatment of corticosteroids or biologics can cause side effects including infections, cancer or death.

BT-11: Our Solution BT-11; our Clinical Lead for IBD

Landos has developed BT-11, an orally active, locally acting small molecule therapeutic that binds to LANCL2 and, as shown in preclinical studies, exerts potent anti-inflammatory effects. Landos received two INDs for BT-11 for evaluation in ulcerative colitis and Crohn’s disease, completed Phase 1 testing in 2018, and is preparing for Phase 2 clinical trial initiation in 2019.

Small molecule therapeutics, local effect: BT-11 has demonstrated a 90% reduction of inflammation by acting locally in the gut mucosa in 4 validated mouse models of IBD at doses of 8 mg/kg/d.

Safe alternative: Preclinical toxicology studies demonstrated that BT-11 is safe to doses up to 1,000 mg/kg/d.

Excellent CMC profile: BT-11 is stable, scalable, amenable to oral modified release formulation, as well as easy and inexpensive to produce.

Human translation: BT-11 has demonstrated excellent human translation in our in vitro human translational studies with cells from Crohn’s disease patients.

BT-11: Superior preclinical results BT-11 has shown superior results in animal pharmacology studies

The Landos team performed studies using mouse models of IBD that demonstrated how BT-11 has better efficacy when compared to anti-TNF antibodies and 5’ASA, as well as GED-0301, based on disease activity index and inflammation in the GI tract (leukocytic infiltration). The protective effects of BT-11 are abrogated in mice lacking its receptor (LANCL2).