Clinical-stage immunology company INmune Bio Inc. (INMB:NASDAQ), which develops treatments that utilize a patient's innate immune system to combat disease, yesterday announced interim clinical data from the Phase 1b study of its leading drug candidate, XPro1595, that demonstrated decreased neuroinflammation in Alzheimer's patients. The firm reported that the interim results showed that "treatment with XPro1595 decreases white matter free water, a biomarker of neuroinflammation measured by MRI."
The company advised that it compared biomarker data gathered from six patients treated with XPro1595 over 12 weeks with data obtained from 25 Alzheimer's patients from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database. The firm indicated that "after 12 weeks whole brain inflammation increased by 5.1% in the ADNI patients compared to an increase of 1.7% and a decrease of 2.3% in patients treated weekly with 0.3mg/kg or 1.0mg/kg of XPro1595, respectively." Notably, the company mentioned that greater in depth analysis revealed that in patients with Arcuate Fasciculus who were treated with XPro1595, a 40.6% reduction in neuroinflammation was achieved.
INmune Bio's Director of Neuroscience CJ Barnum, Ph.D., commented, "We are extremely encouraged by these findings at such an early stage in our clinical trial...Not only do we see a clear reduction in neuroinflammation, but we also know where in the brain this is occurring, which may inform us on the domains of cognition that might be affected."
"The preliminary results from INmune Bio's Phase 1b study add to the growing enthusiasm for tackling neuroinflammation in the treatment of Alzheimer's disease. Furthermore, MRI assessment of free water content in the brain holds promise as an exciting surrogate marker for tracking the impact of such treatment," stated Sharon Cohen, M.D., FRCPC, a neurologist and Medical Director of Toronto Memory Program who, the company noted, was not involved with the clinical trial.
The company explained that "XPro1595 is a next-generation inhibitor of tumor necrosis factor that may possibly have beneficial effects in patients with Alzheimer's disease by decreasing neuroinflammation."
XPro1595 is currently being evaluated in Phase 1b clinical trial in Alzheimer's disease patients who have biomarkers of inflammation to determine if neutralizing soluble TNF can decrease those biomarkers of neuroinflammation. The study includes adults who are greater than 18 years old who have been diagnosed with probable Alzheimer's disease. The study's objective is to determine the safety and ability of XPro1595 to reduce neuroinflammation using a combination of biomarkers of inflammation. The study will also attempt to identify the most effective XPro1595 dosage to be used in a larger future Phase 2 disease modification study. The firm stated that clinical trials are currently underway at several locations across Australia.
INmune Bio is a clinical-stage biotechnology company headquartered in La Jolla, Calif. The firm is engaged in developing treatments that target the innate immune system to fight disease. The firm's DN-TNF product platform is presently being developed for Alzheimer's (XPro595), cancer (INB03™), COVID-19 complications (Quellor™) and NASH (LIVNate™) and its Natural Killer Cell Priming platform is targeted at priming patients NK cells to eliminate minimal residual disease in patients with cancer.
INmune Bio Inc. started off the day with a market capitalization of around $95.8 million with approximately 10.82 million shares outstanding. INMB shares opened nearly 100% higher today at $17.59 (+$8.74, +98.76%) over yesterday's $8.85 closing price and reached a new 52-week high price this morning of $24.42. The stock has traded today between $13.57 and $24.42 per share and is currently trading at $17.65 (+$8.80, +99.44%).[NLINSERT]
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