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Immunic Inc (IMUX)

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  • June 02, 2022, 10:45 UTC

(80% Positive) IMMUNIC, INC. (IMUX) Announces Enrollment Update for Million Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot Oct. 2, 2025, 3:26 a.m.

    📋 IMMUNIC, INC. (IMUX) - Clinical Trial Update

    Filing Date: 2022-06-02

    Accepted: 2022-06-02 06:45:49

    Event Type: Clinical Trial Update

    Event Details:

    Immunic Inc (IMUX) Announces Clinical Trial Update Immunic Inc (IMUX) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: Million, Calcium
    • Diseases/Conditions: Clinical Remission Over Placebo, Multiple Sclerosis
    • Clinical Stage: NCT03341962, phase 2
    • Collaboration: Clinical Data for Both Expected
    • Updated Timeline: the Fourth Quarter of 2023
      • expected Interference Between Vidofludimus Calcium and Concurrent Use of Corticosteroids – – In UC Population Without Concurrent Steroid Use, Pooled Vidofludimus Calcium Data Suggest Activity in Clinical Remission Over Placebo; Counterbalanced by Interference Observed in the UC Population with Concurrent Steroid Use – – Company Does Not Plan Further Development Activities in Ulcerative Colitis Without a Partner – – Focus to Remain on Ongoing Phase 3 Development of Vidofludimus Calcium in Multiple Sclerosis, and Ongoing IMU-935 and IMU-856 Programs with Clinical Data for Both Expected in 2022
      • expected by currently available preclinical or clinical data. “We are disappointed with the results of the CALDOSE-1 trial. The interference of vidofludimus calcium with concurrent corticosteroid use is surprising, and we will further explore the mechanism behind this unexpected observation. We believe that this finding has no consequences for our ongoing program in multiple sclerosis as corticosteroids are not used chronically in this patient population,” stated Andreas Muehler, M.D., Chief Medical Officer of Immunic. “We are also happy to see that, once again, the study data confirm the very favorable safety and tolerability profile of vidofludimus calcium observed in other trials. Importantly, we want to thank all of the investigators, study personnel, patients and caretakers involved in this trial for their participation and tremendous contributions.” “Putting the CALDOSE-1 data in context with the wealth of compelling opportunities we have across our clinical development portfolio, we do not intend to move forward with phase 3 development of vidofludimus calcium in UC on our own,” commented Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “We will use this opportunity to focus our vidofludimus calcium-related efforts around the ongoing multiple sclerosis program, including the phase 3 trials in relapsing multiple sclerosis (RMS) and the phase 2 trial in progressive multiple sclerosis (PMS). As evidenced by data from our phase 2 EMPhASIS trial, we believe vidofludimus calcium holds the potential for meaningful differentiation based on anticipated strong efficacy, unprecedented safety and tolerability, oral delivery, and neuroprotective effects. We also eagerly await further clinical data for IMU-935 and IMU-856 later this year, including phase 1b data of IMU-935 in moderate-to-severe psoriasis patients in the second half, and phase 1 safety data of IMU-856 in healthy human subjects in the third quarter. Both of these investigational medicines hold tremendous potential in their intended indications and beyond. Despite our disappointment with the overall CALDOSE-1 data, the second half of 2022

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Immunic Inc
    • CIK: 0001280776
    • Ticker Symbol: IMUX
    • Period End Date: 2022-06-02
    • Document Type: 8-K

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