Immunic Announces Positive Interim Data From Multiple Sclerosis Trial; Stock Surges

(RTTNews) - Immunic Inc. (IMUX) announced positive interim data from its phase 2 CALLIPER trial of nuclear receptor related 1 activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis or PMS.

IMUX closed Monday regular trading at $1.59 up $0.03 or 1.92%. In the after-hours trade, the stock further gained $0.77 or 48.43%.

The company believes that the data shows biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential.

According to the company, 24-week data from first half of patients showed improvements in biomarker neurofilament light chain or NfL, consistent throughout the overall progressive multiple sclerosis population as well as all subtypes.

Serum NfL responses were consistently observed for vidofludimus calcium across progressive MS disease and all subpopulations. In the overall PMS population at 24 weeks, vidofludimus calcium was associated with a 6.7% reduction from baseline in serum NfL, compared to a 15.8% increase over baseline in placebo.

At 48 weeks, vidofludimus calcium reduced serum NfL by 10.4% from baseline, compared to a 6.4% increase in placebo. Substantial reductions were also seen across all PMS subtypes, as well as in patients that show or do not show disease and/or magnetic resonance imaging (MRI) activity.

Data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of 2025.

Data from the interim analysis of the phase 3 ENSURE program of vidofludimus calcium in relapsing MS is expected in late 2024, with the top-line readout of the first of the ENSURE trials at the end of 2025.