Immunic(US:IMUX)2020-08-03 18:58Financial Data and Key Metrics Changes - Immunic reported positive top-line data from the Phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis, indicating a significant clinical advancement for the company [6][10] - The primary endpoint analysis showed that treatment with 45 mg of IMU-838 suppressed an average of 62% of cumulative unique active (CUA) MRI lesions compared to placebo, with a p-value of 0.0002 [21] - The 30 mg dose of IMU-838 demonstrated a 70% suppression of CUA MRI lesions over 24 weeks compared to placebo, with a p-value of less than 0.0001 [22] Business Line Data and Key Metrics Changes - IMU-838 is currently being tested in multiple clinical trials, including those for ulcerative colitis and COVID-19, showcasing its broad therapeutic potential [11] - The trial included a total of 209 patients, with 197 completing the 24-week blinded treatment period, indicating strong patient retention [18] Market Data and Key Metrics Changes - The global market for multiple sclerosis treatments was approximately $22 billion in 2016, with a significant need for effective oral therapies [13] - The company aims to address the unmet medical need for oral medications that balance safety, tolerability, and convenience for MS patients [14] Company Strategy and Development Direction - Immunic is focusing on developing IMU-838 as a once-daily oral medication for relapsing-remitting MS, emphasizing its favorable safety profile and potential for high patient compliance [14][42] - The company is preparing for a potential Phase 3 program based on the positive Phase 2 data, with plans to engage with regulatory authorities for guidance [41][90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the compelling clinical activity of IMU-838 and its unique safety properties compared to current treatment options [42] - The company is accelerating preparations for Phase 3 testing, indicating confidence in the drug's potential [41] Other Important Information - The trial reported low rates of treatment-emergent adverse events, with only three serious adverse events noted, highlighting the favorable safety profile of IMU-838 [28][39] - No signals for hepatotoxicity were observed in the IMU-838 development program, differentiating it from other MS treatments [32][39] Q&A Session Summary Question: Expected relapse data with two years of treatment based on 24-week results - Management anticipates a more than 30% relapse reduction rate based on the correlation from meta-analysis, pending confirmation in a larger Phase 3 program [46] Question: Initial thoughts on Phase 3 program design - The company plans to follow regulatory guidance and may include a head-to-head trial with an active comparator [49][50] Question: Additional data expected at the September presentation - More detailed safety data and potential signals on EDSS disability progression and brain atrophy data are anticipated [51] Question: Incidence of diarrhea and alopecia rates in the trial - Initial monitoring indicates extremely low incidence rates for these adverse events, with no significant safety concerns expected [56] Question: PML risk with Aubagio and its relevance to IMU-838 - Current understanding suggests that teriflunomide (Aubagio) carries low PML risk, and similar expectations are held for IMU-838 based on its antiviral properties [60] Question: Typical MS patient population in clinical trials - The patient population reflects a shift towards regions with fewer medical resources, which is common in MS clinical trials [61] Question: Effects on total lesion or MRI activity if assessed at 36 weeks - Management believes that longer durations may help with data variability but does not expect a significant change in lesion suppression proportions [66] Question: Additional data needed to prevent a potential black box warning - More patient data showing no acute liver failure cases would be beneficial to alleviate regulatory concerns [68] Question: Curve separation in the study - Separation of treatment arms versus placebo was observed as early as week 6, consistent with other drugs in the category [77] Question: Decision on which dose to carry forward into Phase 3 - No final decision has been made yet, but both doses showed equal efficacy and safety [79] Question: Potential comparators for Phase 3 trials - Comparators will likely include established oral options, but specific details are not yet available [80] Question: Plans for Phase 3 development with potential partners - The company is open to various options, including partnerships, based on the positive data [82] Question: Efficacy at 12 weeks and consistency with previous data - A numerical difference between treatment arms was observed at 12 weeks, but formal statistical analysis was not conducted [100]