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Toxicology Experiments Demonstrate that BT-11 has a Benign Safety Profile

BLACKSBURG, VA: May 31, 2016 – BTI Pharmaceuticals’ program lead for inflammatory bowel disease (IBD)—BT-11—has demonstrated an outstanding therapeutic efficacy in 3 validated mouse models of IBD at doses as low as 8 mg/kg/day in addition to a benign safety profile at doses of 80 to 500 mg/kg. These safety results, which were recently published in the International Journal of Toxicology, demonstrate that BT-11 is well tolerated in rats and holds great promise as an orally active, anti-inflammatory therapeutic for IBD.

“As a toxicologist with over 30 years of experience, I am confident that orally administered BT-11 is safe,” says Virginia-Maryland College of Veterinary Medicine’s toxicologist Marion Ehrich, a former president of the Society of Toxicology, who led the Virginia Tech team in these safety studies and is the corresponding author on the paper. “Our data suggest that BT-11’s chemical properties allow limited systemic exposure after oral administration and that most of the compound reaches the lower gastrointestinal tract where it exerts its efficacious action.”

BTI Pharmaceuticals is advancing BT-11—an orally active, locally acting small molecule therapeutic that binds to Lanthionine Synthetase C-like 2 (LANCL2) and exerts potent anti-inflammatory effects in gut—towards investigational new drug (IND) filing in 2016, plus Phase I and IIa human clinical testing in 2017.

“IBD, a widespread and debilitating disease, afflicts 4 million people worldwide and occurs when the immune system mistakenly destroys healthy gut tissue,” says BTI President and CEO Josep-Bassaganya-Riera. “BTI Pharmaceuticals is working to fill an unmet clinical need for safer and more effective therapeutics for IBD. Our program lead for IBD, BT-11, has the potential to become a first-in-class therapeutic that outperforms current IBD medications without the increased risk for infection, cancer, and death.”

About BioTherapeutics Inc.

BTI Pharmaceuticals, a biotech company, develops disruptive first-in-class therapeutics for inflammatory bowel disease. BTI’s multifaceted approach synergistically combines the power of computational modeling with preclinical and clinical experimentation to accelerate the path to safer and more effective treatments for debilitating and widespread human diseases with unmet clinical needs.

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