Immunic adds Daiichi GI med to pipeline with phase 1 trial on deck

A year after Immunic Therapeutics secured the right to license an inflammatory bowel disease (IBD) program from Daiichi Sankyo, the German biotech is pulling the trigger on that option and preparing to bring it into phase 1. 

The duo struck the deal in November 2018 around IMU-856, a group of compounds with “outstanding new therapeutic potential for patients suffering from ulcerative colitis and Crohn’s disease,” Immunic CEO Daniel Vitt said at the time. 

In exchange for an upfront fee, Immunic picks up the exclusive rights to market IMU-856 in all countries. Daiichi will also pick up payments when the program hits development, approval and sales milestones, as well as royalties. The pair did not disclose financial details of the deal. 

And that’s not all they’re keeping under wraps—neither company has unveiled the protein IMU-856 targets, saying only that it is a transcriptional regulator of intestinal barrier function. The hope is IMU-856 can remedy the inflammation in the digestive tract in patients with IBD without compromising their immune function. Immunic plans to kick off phase 1 studies for the treatment in the first half of this year. 

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The company intends to begin phase 1 clinical studies for this program in the first half of 2020. IMU-856 is an orally available, small-molecule modulator that targets an undisclosed protein that serves as a transcriptional regulator of the intestinal barrier function. As such, IMU-856 represents a new and potentially disruptive approach for the treatment of intestinal diseases with the potential to restore the intestinal barrier function while maintaining immunocompetency. 

The preclinical safety profile has “convinced” Immunic to take the program forward: "Our recently presented preclinical data reinforced our belief that IMU-856 has disease-modifying properties for a variety of intestinal diseases and demonstrates potential significant advantages over current immunosuppressive treatments which address inflammation while unintentionally decreasing the body's immune surveillance,” Vitt said in a statement Wednesday. 

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“We are hopeful that the planned phase 1, single and multiple ascending dose studies will serve as a further important step in the development of IMU-856 as a safe treatment option for patients suffering from gastrointestinal diseases by restoring function to the intestinal barrier without impairing the immune system,” he added. 

IMU-856 will join two other assets in Immunic’s clinical-stage pipeline. IMU-838, which blocks dihydroorotate dehydrogenase, or DHODH, is the furthest along. It's in phase 2 studies in multiple sclerosis, ulcerative colitis and rare liver disease primary sclerosing cholangitis and in phase 1 in Crohn’s disease. Immunic is also developing IMU-935, which activates a type of RORg (retinoic acid receptor-related orphan nuclear receptor gamma) in immune cells, for psoriasis and orphan autoimmune diseases.