Landos Biopharma, a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, announced that the Company has dosed the first patient in a Phase 2 study of omilancor, Landos’ novel, orally administered, gut-restricted LANCL2 agonist, for the treatment of moderate-to-severe Crohn’s disease (CD).
“We are extremely proud of the momentum we have generated this year with the clinical advancement of omilancor, as this trial marks the second indication after ulcerative colitis which is Phase 3-ready,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “Initiating this Phase 2 trial is instrumental in supporting our efforts to showcase omilancor’s ability to exert strong anti-inflammatory effects within the gastrointestinal tract through a novel mechanism of action. With no safe, convenient treatment maintenance options available for the over 100,000 patients worldwide living with moderate-to-severe CD, we believe omilancor, as an oral therapeutic designed to have higher tolerability and a gut-restricted PK profile, may provide a significantly improved therapeutic option.”
This Phase 2 trial is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the proof of concept efficacy and safety of omilancor for the treatment of moderate-to-severe CD. Approximately 150 subjects will be randomized to receive either 1000 mg of omilancor or placebo. Treatment will be evaluated over a 12-week induction period followed by an 18-week maintenance period and 2-week post-treatment safety follow up. The co-primary endpoints will assess clinical remission at Week 12, defined by CDAI < 150, as well as the frequency and severity of AEs compared to placebo. The key secondary endpoints will evaluate the effects of omilancor on disease activity as measured by symptoms, colonoscopy, histology, and biomarkers as well as the health-related quality of life and pharmacokinetic parameters of this product candidate.
“There remains an unmet need for safer, more convenient and effective therapeutic alternatives to treat patients with CD,” said Jean-Frederic Colombel, MD, Director, IBD Center at the Icahn School of Medicine at Mount Sinai and Landos Clinical Advisory Board member. “Oral treatment with omilancor has consistently demonstrated a benign and well-tolerated safety profile, a gut-restricted distribution without systemic immunosuppression, biologic-like efficacy signal and enhanced immunoregulatory mechanisms in UC patients. Based on these encouraging results, we believe omilancor could show similar levels of efficacy in CD patients with a well-tolerated safety profile and ultimately provide long-term benefit for millions of people living with IBD.”
About Crohn’s Disease (CD)
CD is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation and ulcers in any segment of the gastrointestinal tract. CD impacts the end of the small bowel and beginning of the colon most commonly, which in turn can lead to symptoms of abdominal pain, increased abdominal sounds, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss and malnutrition. There are four classes of CD and treatment depends on the level of severity. Current therapeutic options for severe disease, primarily biologics, have several limitations, which include but are not limited to safety risks for malignancies and infections, limited efficacy and lack of long-term maintenance options. There is an urgent need to establish a consensus for a first-line therapy for CD and improve upon the existing constraints in administration and efficacy.
About Omilancor (BT-11)
Omilancor 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, omilancor 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. The Company reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a Phase 3 trial in the second half of 2021. Additionally, Landos initiated a Phase 2 trial of omilancor in patients with Crohn’s disease in the first half of 2021.