Disruptive drug innovation for treating inflammation and diabetes
Crohn’s is an inflammatory bowel disease (IBD) associated with inflammation of the lining of the digestive tract, which can lead to flare-ups. For patients with Crohn’s, inflammation is at the root of their Crohn’s disease symptoms.
While the exact cause of Crohn’s remains unknown, researchers now believe that a combination of genetics, environmental factors and an abnormal immune response may result in damaging inflammation of the digestive tract. Abdominal pain and cramping are two of the many Crohn’s disease symptoms.
Problems with Current Treatment
Expensive, Risky and not that Effective
The current treatment paradigm for Crohn’s disease depends upon the severity of the disease. BTI Pharmaceuticals LANCL2 technology will 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 $30,000 to $40,000 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 Crohn’s Disease
BTI Pharmaceuticals has developed BT-11, an orally active, locally acting small molecule therapeutic that binds to LANCL2 and exerts potent anti-inflammatory effects. BTI is advancing BT-11 towards IND filing. Phase I clinical testing is expected to happen at the end of 2016.
Small molecule therapeutics, local effect: BT-11 has demonstrated a 90% reduction of inflammation by acting locally in the gut mucosa.
Safe alternative: Preliminary toxicology studies demonstrated that BT-11 is a safe candidate at high doses.
Excellent CMC profile: BT-11 is stable, scalable, amenable to oral modified release formulation, as well as easy and inexpensive to produce.
Ensured 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 efficacy compared to competitors
BT-11 has shown superior results in animal pharmacology studies
The BTI Pharmaceuticals team performed preliminary studies using a DSS mouse model of colitis 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 (DAI) and inflammation in the colon (leukocytic infiltration).
BT-11: Great potential in human clinical trials
In silico clinical trials 12,500 Crohn’s disease patients showed that BT-11 has an efficacy than anti-TNF-a antibodies and GED0301.