2023-05-04 08:07:28 ET
Immunic ( NASDAQ: IMUX ) reported data from part C portion of its phase 1 trial of IMU-856 in patients with celiac disease.
Celiac disease is a chronic digestive and immune disorder which damages the small intestine. The disorder is an immune reaction to eating gluten.
The company said positive effects by IMU-856 were seen over Placebo in four key areas of disease pathophysiology.
Protection of gut architecture and reduction of gluten-induced intestinal damage — the placebo group (N=11) experienced a 60.3 ?m reduction in villous height after 4 weeks of treatment and 2 weeks of 6 g/day gluten challenge. In comparison, the reduction was 20.9 ?m and 22.5 ?m for the 80 mg (N=11) and 160 mg (N=13) IMU-856 groups.
The company said decrease in villous height is a measure of gluten-induced damage in celiac disease.
Improvement of patients' symptoms related to gluten exposure: On the first day of gluten challenge, the placebo group (N=12) showed an average increase in symptoms, of 0.8 for nausea, 0.8 for abdominal pain, and 0.8 diarrhea.
Meanwhile in the pooled IMU-856 groups (N=26), the average increases were 0.4 for nausea, 0.5 for abdominal pain and 0.6 for diarrhea, according to the company.
After starting the gluten challenge on day 14, patients on IMU-856 showed a dose-dependent reduction of acute immune response, as measured by serum interleukin-2 (IL-2) release, compared to placebo.
In addition, the placebo group (N=11) showed a 31.0 pmol/L reduction in levels of vitamin B12. Whereas, the IMU-856 80-mg (N=11) showed a 45.8 pmol/L increase and 160 mg (N=13) exhibited a 74.2 pmol/L increase in vitamin B12 levels.
IMU-856 was seen to be safe and well-tolerated, the company added.
"We believe today's data strongly corroborates IMU-856's potential to regenerate the gut wall as measured through a variety of key parameters," said Immunic President and CEO Daniel Vitt.
The trial was conducted in Australia and New Zealand and a total of 43 patients were enrolled, who received either 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days.
IMUX -0.49% to $1.72 premarket May 4
For further details see:
Immunic's celiac disease drug shows promise in ongoing phase 1 trial