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Immunic, Inc. Announces Positive Top-Line Data From Investigator-Sponsored Phase 2 Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing Cholangitis
- Statistically Significant Decrease in Serum Alkaline Phosphatase (ALP) Levels in the Per-Protocol Population After 24-Week IMU-838 Treatment, as Compared to
About this update from Immunic, Inc.
[{"type":"text","content":"- Statistically Significant Decrease in Serum Alkaline Phosphatase (ALP) Levels in the Per-Protocol Population After 24-Week IMU-838 Treatment, as Compared to Baseline -\n - Primary Objective of Therapeutic Benefit Achieved in 27.3% of the Patients of the Per-Protocol Population at Week 24 -\n - Other Liver Biochemistry Parameters Remained Stable -\n - IMU-838's Favorable Safety and Tolerability Profile Confirmed in This Patient Population -\n - Study Conducted in Collaboration with Investigators at Mayo Clinic in Arizona and Minnesota -\n - Conference Call and Webcast to be Held on February 18, 2021 at 8:00am ET -\n\n\nNEW YORK, Feb. 18, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced positive top-line data from an investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis (PSC). This single-arm, open-label, exploratory study was designed to investigate IMU-838's potential to improve various biochemical parameters in PSC patients and help determine whether any such activity warrants further investigation in randomized PSC trials. As previously announced, due to the COVID-19 pandemic, only 18 of the targeted 30 patients were enrolled in the study (intent-to-treat population, ITT), of whom only 11 patients completed the full IMU-838 treatment course and were evaluable over the 24-week treatment period (per-protocol population, PP).\nThe PP population experienced a statistically significant decrease in serum alkaline phosphatase (ALP) levels (p=0.041) after 24 weeks of treatment using 30 mg IMU-838 once daily, as compared to baseline. A consistent individual pattern of a stable decrease in ALP values was observed in the PP population between baseline and week 24, without any single patient showing an increase of more than 20% of ALP. As per the definition of the primary objective of the study, 27.3% of the patients in the PP population had a clinically relevant reduction of serum ALP higher than 25% at week 24, without an increase in liver biochemistry of more than 33%, as compared to baseline. Biochemical endpoints, such as changes in serum ALP, have been used in PSC trials performed by third parti...