Landos Biopharma announced positive results from a first-in-patients 12-week Phase 2 proof-of-concept trial of BT-11, a novel, orally administered, gut-restricted LANCL2 modulator in patients with mild to moderate ulcerative colitis (UC). The objective of the Phase 2 trial was to evaluate the safety and efficacy of BT-11 compared to placebo in subjects with mild to moderate UC. The Phase 2 study is a randomized, placebo-controlled, double-blind, parallel-group multicenter study which enrolled 198 UC patients in 53 sites throughout the U.S., Europe and Russia. Dosing was explored in two BT-11 cohorts (500 mg QD and 1,000 mg QD) or placebo (randomized 1:1:1) and clinical remission was analyzed over a 12-week induction period, as defined by the 3-component modified Mayo Score, using a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1. In the intent-to-treat (ITT) population, a positive trend in absolute clinical remission rates for the 1,000 and 500 mg doses compared to placebo was observed (31.8% and 30.3% versus 22.7%; p=0.340 and 0.235). The resulting placebo-adjusted clinical remission rates of 9.1% and 7.6% for the 1,000 and 500 mg dose groups, respectively, are consistent with standard of care treatments in both mild to moderate and moderate to severe UC. In a more moderate subset of patients (with Mayo score equal to or greater than 7 at baseline) the placebo-adjusted clinical remission rate was (11.5%; p=0.153 and 8.7%; p=0.273) for the 1,000 (n=47) and 500 mg (n=44) dose groups respectively versus placebo (n=50). Additionally, in a small subset of biologic experienced patients, positive placebo-adjusted remission trends were also observed (66% and 33% in the 1,000 (n=3) and 500 mg (n=3) cohorts versus placebo n=3, 0%). Normalization of fecal calprotectin levels, commonly cited to be one of the most predictive biomarkers of response to treatment in UC and Crohn’s disease, was detectable in a subset of patients (n=106) with abnormal baseline calprotectin levels (>250 ug/g), after 2 weeks of oral dosing in over 40% of patients treated with BT-11 (n=64), at either dose level, when compared to 21% of patients receiving placebo (n=42). Additionally, the ability of BT-11 to normalize fecal calprotectin levels was maintained for the entire 12-week period. Notably, in patients with elevated baseline fecal calprotectin levels (>250 ug/g), an indication of active disease, BT-11 dosing provided a placebo-adjusted clinical remission rate of up to 13.1%. BT-11 was well tolerated with similar adverse events across placebo and BT-11 groups. Pharmacokinetic measurements confirmed dose proportional increases of BT-11 in stool samples across each dosing group. BT-11 was confirmed to be gut-restricted with no evidence of greater systemic absorption or increased exposure over time in UC patients relative to normal healthy volunteers. BT-11 stool concentrations were stable between 2 and 12 weeks of dosing. With the Phase 2 study results in hand demonstrating proof-of-concept clinical efficacy and safety of BT-11 for patients with mild to moderate UC, Landos plans to advance development of this product candidate with a Phase 3 trial in 2021. The Phase 3 trial of BT-11 will evaluate induction of clinical remission at week 12 and maintenance of clinical remission at week 52 in patients with UC. Additionally, the Company plans to initiate its Phase 2 trial of BT-11 for 150 patients with moderate to severe Crohn’s disease in the first half of 2021. About BT-11: BT-11 is a novel, orally-active, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway impacting the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, BT-11 is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation.?BT-11 has shown demonstrated therapeutic activity in 5 preclinical models of IBD, a benign safety profile without the concerns of systemic exposure in preclinical and Phase 1 clinical studies and has two open INDs for evaluation in UC and CD. The Company completed Phase 1 testing of BT-11 in 2018 and initiated Phase 2 testing in 2019.