Landos Biopharma has signed a research partnership with the Icahn School of Medicine at Mount Sinai to carry out a Phase III clinical trial of its investigational drug, omilancor, in moderate-to-severe Crohn’s disease (CD) patients.

Developed using Landos’ LANCE Advanced A.I. platform, omilancor is a new, oral, gut-restricted, small-molecule drug.

Omilancor acts on the Lanthionine Synthetase C-Like 2 (LANCL2) pathway affecting the gastrointestinal tract, Landos noted.

The randomised, double-blind Phase II trial will assess the efficacy, safety and mechanisms of omilancor in moderate-to-severe CD patients.

It will enrol nearly 40 subjects, who will be categorised to receive either an 880mg dose of omilancor or the standard of care, adalimumab (Humira), once a day for 12 weeks.

During the induction period, patients will be monitored at baseline, two, six and 12 weeks for evaluating symptoms, disease-linked biomarkers and patient-reported outcomes.

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Intestinal biopsy specimens, stool and peripheral blood will be broadly assessed at the Laboratory of Mucosal Immunology at Mount Sinai Hospital.

Furthermore, the US National Institutes of Health (NIH) unit National Institute of Diabetes and Digestive and Kidney Diseases granted $3m to Landos to fund the Phase II trial of omilancor.

Landos Biopharma chairman, president and CEO Dr Josep Bassaganya-Riera said: “Entering this partnership with the Icahn School of Medicine at Mount Sinai highlights our ability to pursue innovative clinical and translational studies that build on our pioneering immunometabolism franchise in autoimmune diseases.

“We are excited to expand the investigation of our Phase III ready product candidate, omilancor, in this mechanistic Phase II study in CD to further validate how activation of the LANCL2 pathway by omilancor enhances regulatory T cell (Treg) function in the gastrointestinal tract.”

A chronic, autoimmune disease of the gastrointestinal (GI) tract, CD causes inflammation, irritation and ulcers in any segment of the GI tract.

In 2018, Landos dosed the first cohort of subjects in a Phase l study designed to investigate the safety and tolerability of BT-11 for the treatment of inflammatory bowel disease, including ulcerative colitis and CD.