Immunic Inc (NASDAQ:IMUX) said the results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease are positive, providing what the company believes as initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders.
The data showed that there was protection of gut architecture and reduction of gluten-induced intestinal damage, improvement of the symptoms related to gluten exposure experienced by patients, dose-dependent changes in biomarker responses and the enhancement of nutrient absorption.
"We believe today's data strongly corroborates IMU-856's potential to regenerate the gut wall as measured through a variety of key parameters," Dr Daniel Vitt, CEO and president of Immunic said in a statement.
"IMU-856 was designed to restore a healthy gut without targeting the immune system, thus avoiding the immune dysfunction inherent in current approaches. Ultimately, IMU-856 could represent a possible game-changer in not only celiac disease, but also other gastrointestinal disorders with high unmet needs such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea. We are eagerly preparing clinical phase 2b testing of IMU-856 in ongoing active celiac disease, while also considering other potential clinical applications for this first-in-class and orally available molecule," Dr Vitt added.
The company also noted that the trial observed that IMU-856 as safe and well tolerated.
Part C of the phase 1 clinical trial was structured as a double-blind, randomized, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge, the company said.
"The study demonstrated consistent and meaningful improvements for IMU-856 treatment over placebo in four key dimensions of celiac disease. We were delighted to see the dose-dependency, the consistency of improvement over placebo in a wide array of key histologic, symptomatic, nutritional and immunologic parameters, as well as a clean safety and tolerability profile. We were particularly excited to see the level of protection against histological deterioration by IMU-856 during gluten challenge, with some actively treated patients even displaying histologic improvements despite repeated daily exposure to gluten,” said Andreas Muehler, M.D., chief medical officer of Immunic.
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