Landos Biopharma’s investigational BT-11 therapy for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), is continuing testing in Phase 2 clinical trials — some of which are, or soon will be, enrolling participants.
BT-11 is a small molecule, given orally, that binds to a protein called LANCL2, leading to a potent anti-inflammatory response. Importantly, the action of BT-11 is restricted to the gut.
Now, Landos has secured $60 million in new funding that will support the BT-11 clinical program, the company announced.
“This financing is an important part of our strategy to advance lead product BT-11 into global Phase 2 clinical trials for ulcerative colitis and Crohn’s disease,” Josep Bassaganya-Riera, president and CEO of Landos, said in a press release.
“There is an unmet clinical need for new therapies for complex diseases such as Inflammatory Bowel Disease. We are pleased that our investors share Landos’ mission of accelerating drug development and serving the unmet needs of millions of patients living with these widespread and debilitating conditions,” he added.
Preclinical (in the lab) studies showed that treating four mouse models of inflammatory bowel disease with BT-11 decreased inflammation in the gut by 90%. Further, in other mouse models, BT-11 showed better results than other, more expensive IBD medicines. The researchers said BT-11 outperformed anti-TNF antibodies, aminosalicylate medicines known as 5-ASA, and Celgene’s GED-0301.
A randomized Phase 1 clinical trial (NCT03860571) assessed the safety and tolerability of BT-11 in 70 healthy people. The participants were randomly selected to receive single or multiple increasing doses of BT-11 or a placebo.
Results from that first-in-human study showed that BT-11 was well-tolerated, with no dose-limiting toxicities. Moreover, the levels of fecal calprotectin, a protein found in the feces when intestinal inflammation occurs, were lower in participants treated with BT-11 compared with those treated with placebo. The investigators noted that fecal calprotectin is a potential biomarker for IBD.
The findings were outlined in a study titled, “The Safety, Tolerability, and Pharmacokinetics Profile of BT-11, an Oral, Gut-Restricted Lanthionine Synthetase C-Like 2 Agonist Investigational New Drug for Inflammatory Bowel Disease: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.” The study was published in the journal Inflammatory Bowel Diseases.
A Phase 2 trial (NCT03861143) now is recruiting 195 people with mild to moderate ulcerative colitis — as defined by total Mayo scores of 4 to 10 — to assess the efficacy and safety of BT-11.
Participants will be randomly selected to receive either a low-dose (500 mg) or a high dose (1,000 mg) of BT-11 or a placebo. The trial’s main goal is to assess the clinical remission rate over 12 weeks. Clinical remission is defined as achieving a total Mayo score of 2 or less, with all subscores at 1 or less.
The trial will take place across 46 sites in Europe and the U.S. Two sites in Texas are currently enrolling participants. For more information on enrollment, please see the clinical trial page.
A second Phase 2 clinical trial (NCT03870334) will target Crohn’s disease. That study will assess the efficacy and safety of BT-11 in approximately 130 patients with moderate-to-severe disease.
A main goal of this trial is to assess the clinical remission rate over 12 weeks — with clinical remission defined as a Crohn’s Disease Activity Index score lower than 150. The study also seeks, as a primary endpoint, to determine the proportion of participants who show a 50% decrease from baseline in scores on the Simplified Endoscopic Index of Severity for Crohn’s Disease (SES-CD).
This trial is not yet recruiting participants, but approximately 70 different sites from Europe and the U.S. will participate. For more information, please see the clinical trial page.
“We believe BT-11’s mechanism of action is differentiated with the potential to transform the current treatment paradigm for patients with ulcerative colitis and Crohn’s disease,” said Rod Wong, managing partner at RTW Investments and a new member of the Landos Board of Directors.
Landos’ new financing was co-led by RTW Investments and Perceptive Advisors (Perceptive Xontogeny Venture Fund and Perceptive Life Sciences Fund). They were joined by additional new investors, including Osage University Partners and PBM Capital.
“We believe there is tremendous commercial potential for an oral compound for IBD and BT-11 is the most promising candidate we’ve seen at this stage of development,” said Chris Garabedian, portfolio manager, Perceptive Xontogeny Venture Fund.