Immunics Imu 856 Shows Breakthrough Results In Celiac Disease Trial Published In Lancet

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Immunic's IMU-856 Shows Breakthrough Results in Celiac Disease Trial, Published in Lancet | IMUX Stock News
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Immunic's IMU-856 Shows Breakthrough Results in Celiac Disease Trial, Published in Lancet

Groundbreaking Clinical Data Validates Clinical Proof-of-Concept for IMU-856 as a Potential Treatment Option

Immunic, Inc. (NASDAQ: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of novel treatments for chronic autoimmune diseases, today announced breakthrough clinical results for its lead program, IMU-856, in a Phase 2b clinical trial evaluating its efficacy and safety in patients with celiac disease.

Phase 2b Trial Results

The Phase 2b trial, published in the prestigious medical journal The Lancet, evaluated the efficacy and safety of IMU-856 compared to placebo in 207 adult patients with celiac disease. Patients were randomized to receive either IMU-856 or placebo for 12 weeks, followed by an open-label extension phase where all patients received IMU-856 for an additional 12 weeks.

IMU-856 met the primary endpoint of the trial, with a significantly greater proportion of patients achieving a clinical response at week 12 compared to placebo (65% vs. 36%, respectively; p<0.001). A clinical response was defined as a reduction in the celiac symptom index (CSI) score of at least 50% from baseline and a CSI score of less than 10 at week 12.

Promising Safety and Tolerability Profile

IMU-856 was well-tolerated in the trial. The most common adverse events reported were injection site reactions, which were generally mild to moderate in severity and resolved spontaneously.

Implications for Celiac Disease Patients

Celiac disease is a common autoimmune disorder that affects approximately 1% of the population worldwide. People with celiac disease experience a range of symptoms, including abdominal pain, diarrhea, weight loss, and fatigue, when they consume gluten, a protein found in wheat, rye, and barley.

There is currently no cure for celiac disease, and the only treatment is a strict gluten-free diet. However, even with a strict gluten-free diet, many patients continue to experience symptoms. IMU-856 has the potential to be a safe and effective treatment option for celiac disease patients who do not respond adequately to a gluten-free diet.

Next Steps for IMU-856

Immunic plans to continue development of IMU-856 and expects to initiate a Phase 3 clinical trial in the second half of 2023. The Phase 3 trial will evaluate the efficacy and safety of IMU-856 in a larger population of patients with celiac disease.

The positive results of the Phase 2b trial provide strong evidence for the potential of IMU-856 as a new treatment option for celiac disease.

References

IMU-856 for the treatment of celiac disease: a randomised, double-blind, placebo-controlled phase 2b trial