DGAP-News: Immunic, Inc.
/ Key word(s): Study results/Conference
Immunic, Inc. Publishes Full Unblinded Clinical Data From Phase 2 EMPhASIS Trial of IMU-838 in Patients With Relapsing-Remitting Multiple Sclerosis and Announces Poster Presentation at the MSVirtual2020 - Time Course of MRI Lesion Suppression Shows Reduction of Lesions Already Present at First Post-Baseline Scan at Week 6, Validating Rapid Attainment of Stable Therapeutic Drug Levels of IMU-838 - - A Robust Decrease in Serum Neurofilament Light Chain, A Biomarker for Axonal Damage, Was Observed in Both Treatment Arms of IMU-838 But Not in the Placebo Arm - - Poster, Including Audio Track, With Summary of Full Data Set, to be Presented Online at the MSVirtual2020 / 8th Joint ACTRIMS-ECTRIMS Meeting by Robert J. Fox, M.D. - Abstract Title: Top-line Results of EMPhASIS, a Phase 2 Clinical Trial of Vidofludimus Calcium (IMU-838) in Relapsing-Remitting Multiple Sclerosis The poster presentation, including Dr. Fox's audio track, will be published today at 8:00 am ET in the MSVirtual2020 E-Poster Hall. Dr. Fox's poster presentation as well as the full unblinded EMPhASIS data will be filed on Form 8-K today, before the opening of the U.S. financial markets, and will be accessible on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. As previously announced, the phase 2 EMPhASIS trial achieved all primary and key secondary endpoints. In particular, the study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24 in patients receiving 45mg of IMU-838 once-daily, by 62% (p=0.0002), as compared to placebo. The study also met its key secondary endpoint, showing a statistically significant reduction in the cumulative number of CUA MRI lesions for the 30mg once-daily dose, by 70% (p<0.0001), as compared to placebo. Subgroup analyses of the full unblinded data set showed a consistent effect for MRI lesion suppression across different populations, including a treatment effect independent of the presence of pre-study treatment (being treatment-naïve or experienced), of number of relapses before study or of country of enrollment. Further, the time course of MRI lesion suppression indicated that the reduction of lesions was already present at the first time point of assessment in the trial (week 6), which is consistent with the rapid attainment of stable therapeutic drug levels which has previously been shown for IMU-838. Other secondary endpoints beyond MRI effect, such as relapse activity or changes in Expanded Disability Status Scale (EDSS), a measurement of neurological status for patients, showed trends toward an advantage for IMU-838 treatment groups versus placebo regarding time-to-first relapse and annualized relapse rate, although the study's duration was too short to provide a formal assessment. This indicates that the MRI activity seen in the IMU-838 arms may translate into activity for clinical relapse-related endpoints in future studies with longer follow-up durations, as also supported by a third-party meta-analysis of other trials in RRMS. Both treatment arms for IMU-838 provided a robust decrease of serum neurofilament at 24 weeks (-17.0% for 30mg and -20.5% for 45mg) as compared to baseline values, while patients on placebo experienced a small 6.5% increase in serum neurofilament over the same period. A decrease in serum neurofilament light chain, a biomarker for axonal damage, which has been shown consistently to correlate with neurodegenerative and neuroinflammatory processes, has become one of the most important serum biomarkers for MS over the past few years. Consistent with the company's earlier announcement regarding top-line data, the full unblinded data set also confirms that IMU-838 was very well tolerated, in general, and that its safety profile was similar to the placebo group. The most common treatment-emergent adverse events were headache and nasopharyngitis, which occurred in more than 5% of both IMU-838 and placebo treated patients. Adverse events (AE) were generally mild, and only one AE of severe intensity (in the placebo group) occurred. In addition, only three patients experienced serious AEs in this study, one in the placebo arm (cervical carcinoma) and two in the IMU-838 treatment arms (open fracture, ureterolithiasis/hydronephrosis). The lack of any hepatotoxicity signal in the AE reports was confirmed by a detailed analysis which showed no generalized effect on liver enzymes or bilirubin. No generalized effect on hematological parameters and no cases of neutropenia, leukopenia or lymphopenia were observed during treatment with IMU-838. In addition, and confirming the findings from the company's phase 1 multiple ascending dose trial of IMU-838 with doses of up to 50mg/day with a 1-week dosing-in using half-dose of IMU-838, the EMPhASIS study did not show a generalized effect on serum uric acid levels or an increased incidence of hematuria at either dose of IMU-838. The rate of treatment withdrawals in the 24-week blinded treatment period was only 4.3% in the pooled IMU-838 treatment arms versus 7.2% in the placebo group. "The complete study data significantly boosts our confidence about the potential for IMU-838 as a novel, oral treatment of choice for RRMS," noted Andreas Muehler, M.D., Chief Medical Officer of Immunic. "In particular, the results show that both doses of IMU-838 were equally effective when looking at all efficacy-related measurements and biomarkers, and that neither dose presented any safety concerns that would be an important differentiator. From the full analysis of this phase 2 trial, we believe that the 30mg/day dose of IMU-838 should be considered the most appropriate dose for the extended treatment of the RRMS patients still remaining in this trial." "The strength of the full unblinded data set from the EMPhASIS trial corroborates our belief that IMU-838 could provide RRMS patients with a distinctive combination of robust efficacy combined with favorable safety and tolerability," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "The reduction of MRI lesions observed at the very first post-baseline scan in the trial is extremely exciting and suggests quick onset of effect for this drug. The discontinuation rate, which was substantially below that of patients on placebo, indicates an encouraging combination of tolerability and efficacy, and we were pleased to see favorable data regarding overall treatment satisfaction, as measured by the patient reported questionnaires. We believe that the absence of hepatotoxic signals and other adverse events distinguishes IMU-838 well from other oral RRMS treatments, and that the lowering of neurofilament levels provides evidence of neuroprotective activity. Given these impressive results, we are continuing to prepare a clinical phase 3 program for IMU-838 in RRMS and will give more guidance on next steps once our discussions with experts as well as regulatory authorities have been completed." The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS. Of the 210 patients randomized in 36 centers across four European countries, 209 patients received at least one dose of IMU-838 or placebo (placebo n=69, 30mg IMU-838 n=71, 45mg IMU-838 n=69), and 198 patients completed the blinded 24-week treatment period. All enrolled patients were required to have shown disease activity based on clinical evidence of relapse and additional MRI criteria. The primary and key secondary endpoints were the cumulative number of CUA MRI lesions, up to week 24, for 45mg and 30mg of IMU-838, respectively. MRI was performed at baseline and at weeks 6, 12, 18 and 24, and was evaluated centrally by an independent, blinded MRI reader. The study includes an optional, extended treatment period for up to 9.5 years to evaluate long-term safety and tolerability of IMU-838. To participate in the conference call, dial 1-877-870-4263 (USA) or 1-412-317-0790 (International) and ask to be joined into the Immunic, Inc. call. A live, listen-only webcast of the conference call can be accessed at https://www.webcaster4.com/Webcast/Page/2301/37321 or on the "Events and Presentations" section of Immunic's website at ir.imux.com/events-and-presentations. An archived replay of conference call and webcast will be available approximately one hour after the completion for one year on Immunic's website at: ir.imux.com. About Relapsing-Remitting Multiple Sclerosis About IMU-838 About Immunic, Inc. Cautionary Statement Regarding Forward-Looking Statements Contact Information US IR Contact US Media Contact 11.09.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
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