During extended trading hours, INmune Bio, Inc. (NASDAQ: INMB) had a notable spike, with its shares rising 83.28% to $11.51. This upswing followed a regular session decline of 14.79%, where INMB stock closed at $6.28. Following the company’s release of impending findings from its Phase 2 MINDFuL clinical study, which targets early Alzheimer’s Disease (AD), a significant milestone in its research pipeline, there was turbulence.
Upcoming Conference Call and Trial Overview
On Monday, June 30, INmune Bio (INMB) will have a conference call to provide the top-line results of the Phase 2 MINDFuL study, which assesses the effectiveness of its experimental medication, XPro, in treating individuals with early-stage Alzheimer’s disease. INmune Bio showcased baseline data and participant biomarker profiles at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in Vienna earlier this year, where it revealed first findings.
With an average participant age of 72, the MINDFuL experiment is a blinded, randomized research that includes people with moderate AD or mild cognitive impairment (MCI). Over the course of 23 weeks, subjects were randomized in a 2:1 ratio to receive weekly subcutaneous injections of either 1.0 mg/kg of XPro or a placebo.
Trial Endpoints and Patient Characteristics
The primary endpoint of the trial is the change in cognitive performance using the Early and Mild Alzheimer’s Cognitive Composite (EMACC), a tool specifically designed for early-stage AD trials. EMACC scores at baseline were higher in MCI patients and strongly correlated with other validated scales like MMSE and CDR-SB. Notably, 69.2% of participants were APOE ε4 carriers, and 64.4% met inclusion criteria for more than one inflammatory biomarker.
Secondary Measures and Future Updates
Secondary outcomes include assessments using CDR-SB, E-Cog, ADL, the Neuropsychiatric Inventory (NPI), blood-based biomarkers, and neuroimaging. The patient cohort showed remarkable similarity to those in successful Phase III studies. INmune Bio (INMB) had previously indicated plans to release topline MINDFuL trial results by June, a catalyst that has now ignited renewed investor interest in its shares.
