Immunic Inc (NASDAQ:IMUX) said it has presented new clinical and pre-clinical data on the molecule IMU-856 at Digestive Disease Week (DDW) 2023 currently underway in Chicago.
The presentation includes data on how IMU-856 has been shown to have a beneficial effect on gut health by helping to modulate, stabilize and enhance expression of the Sirtuin 6 (SIRT6) protein in the gastrointestinal tract.
SIRT6 is important for regulation of intestinal barrier function and regeneration of bowel epithelium.
IMU-856 has been shown to restore and renew the intestinal lining in both animal and early clinical studies, while in a preclinical trial, IMU-856 treatment protected and improved regeneration of the gut lining.
Meanwhile, data from the phase 1b clinical trial, announced on May 4, 2023, corroborated these findings in a proof-of-concept trial in celiac disease patients, where treatment with IMU-856 showed benefits including protecting the gut against the effects of the gluten challenge, and improvements in gut health.
"By restoring intestinal barrier function and bowel wall architecture through its effect on SIRT6, IMU-856 may offer a unique treatment option for patients suffering from gastrointestinal diseases," said Hella Kohlhof, PhD, chief scientific officer of Immunic in a statement.
"Of particular interest, in preclinical studies, IMU-856 was shown to avoid suppression of immune cells and may therefore maintain immune surveillance for patients during therapy, representing a distinct advantage when compared with chronic administration of potentially immunosuppressive medications.
“Additionally, our preclinical studies showed that treatment with IMU-856 results in two important effects. First, the SIRT6 protein is stabilized, and second, de-acetylation of target structures by SIRT6 is prevented, leading to a regenerative phenotype."
Daniel Vitt, Ph.D., chief executive officer and president of Immunic added: "As recently reported, celiac disease patients treated with IMU-856 in the proof-of-concept trial showed a meaningful improvement in a wide array of key histologic, symptomatic, nutritional and immunologic parameters during gluten challenge, while IMU-856 continued to show a clean safety and tolerability profile.”
Vitt highlighted the potential of IMU-856 beyond celiac disease, including gastrointestinal diseases with high unmet needs such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea, all of which are characterized by compromised intestinal barrier function.
Vitt added that Immunic is now preparing for a phase 2b clinical trial of IMU-856 in celiac disease patients, while also considering other indications.
Immunic is a biotechnology company developing a clinical pipeline of orally administered, small-molecule therapies for chronic inflammatory and autoimmune diseases.
Contact the author at jon.hopkins@proactiveinvestors.com