Immunic(US:IMUX)2025-04-30 12:00Summary of the Conference Call on CALIBER Trial Results Company and Industry Overview - Company: Munich - Industry: Multiple Sclerosis (MS) Treatment - Product: Beta-flutamious calcium (venoflunomous calcium), a novel treatment for various forms of MS, particularly progressive MS Key Points and Arguments 1. CALIBER Trial Overview: The CALIBER Phase II clinical study focused on beta-flutamious calcium for patients with progressive MS, specifically targeting non-active disease forms [4][12] 2. Patient Demographics: Approximately 120,000 patients diagnosed with primary progressive MS (PPMS) and 175,000 with secondary progressive MS (SPMS) in the U.S. and EU5 [7][32] 3. Unmet Medical Need: There is a significant unmet need in treating disability progression in MS, with only one approved drug for PPMS and no treatments for non-active SPMS [9][10] 4. Mechanism of Action: Beta-flutamious calcium is a first-in-class drug that activates NUR1 for neuroprotection and inhibits DHODH to reduce inflammation [6][38] 5. Study Design: The trial included 467 patients, focusing on those without recent relapse events, and aimed to assess the drug's neuroprotective effects [17][12] 6. Results on Disability Worsening: The trial showed a 20% decrease in confirmed disability worsening events at 24 weeks for beta-flutamious calcium compared to placebo, with a 30% reduction in PPMS patients and 15% in non-active SPMS patients [21][22] 7. Safety Profile: No new safety signals were identified, and treatment-emergent adverse events were similar between treatment and placebo groups [29][30] 8. Market Opportunity: The global market for primary progressive MS therapies is estimated at $6 billion, with significant potential for beta-flutamious calcium to capture market share due to its unique profile [36][39] 9. Future Steps: Discussions with healthcare authorities will determine the next steps for further development and potential approval pathways, including a Phase III trial focusing on PPMS [41][42] Additional Important Insights 1. Comparison with Existing Treatments: Current treatments like ocrelizumab have limitations, including safety concerns and administration difficulties, highlighting the need for a more convenient and safer option [34][35] 2. Potential for Breakthrough Designation: The company is considering applying for breakthrough designation based on the promising results from the CALIBER trial [42][96] 3. Long-term Vision: The company aims to establish beta-flutamious calcium as a cornerstone treatment for both relapsing and progressive forms of MS, with projected peak sales ranging from $3 billion to $7 billion [39][38] 4. Regulatory Considerations: The company is preparing for discussions with regulators to ensure the design of the Phase III trial meets approval requirements [62][96] This summary encapsulates the critical findings and strategic implications from the conference call regarding the CALIBER trial results and the future of beta-flutamious calcium in the MS treatment landscape.