Summary of Immune Bio's Mindful Phase Two Topline Data Conference Call Company and Industry - Company: Immune Bio - Industry: Alzheimer's Disease Treatment Key Points and Arguments Trial Overview - The MINDFUL trial is a double-blind, placebo-controlled Phase II trial evaluating Xpro for early Alzheimer's disease in patients with biomarkers of inflammation [6][14] - The trial included a modified intent to treat population of 200 patients, with a focus on a biologically defined group of 150 patients with early Alzheimer's disease confirmed by amyloid positivity and at least one biomarker of inflammation [10][11] Results and Efficacy - Xpro was found to be safe for early Alzheimer's patients and showed potential effectiveness in a defined patient population [6][12] - The primary endpoint was not met in the overall modified intent to treat population, but a consistent benefit was observed in the subgroup of patients with two or more biomarkers of inflammation [11][20] - The effect size for the primary endpoint (EMAC) was 0.27, indicating a meaningful benefit in cognition for the targeted patient group [19][20] - Positive effects were also noted on secondary endpoints related to behavior and disease-relevant biomarkers in the blood, including p tau 217 [11][19] Safety Profile - Xpro demonstrated a favorable safety profile with no deaths and no cases of ARIA (Amyloid-Related Imaging Abnormalities) reported [17][22] - The most common adverse event was injection site reactions, occurring in 80% of patients receiving Xpro, but these were manageable and did not lead to significant complications [25][28] Future Development Plans - Immune Bio plans to explore partnership opportunities and prepare for an end-of-phase two meeting with the FDA to discuss regulatory pathways and potential breakthrough designation [7][85] - The company aims to confirm EMAC as a primary cognitive endpoint with the FDA, which could facilitate a more efficient Phase III trial design [48][79] Market Implications - The trial results suggest a potential path forward for Xpro as a best-in-class therapy for early Alzheimer's disease, particularly in patients with neuroinflammation [14][28] - Immune Bio is committed to advancing Xpro's development and addressing the needs of Alzheimer's patients and their caregivers [82][85] Additional Important Content - The trial faced challenges with patient screening, leading to the exclusion of 50 patients who were not confirmed to have Alzheimer's disease [52][68] - The company emphasized the importance of biomarkers in understanding disease progression and treatment efficacy, noting that p tau 217 is gaining recognition as a significant prognostic indicator [44][70] - Immune Bio acknowledged the need for effective therapies for Alzheimer's, highlighting the trial's contribution to understanding neuroinflammation's role in the disease [28][82]
INmune Bio (INMB) Update / Briefing Transcript