INmune Bio Inc. Completes Enrollment for Phase 2 Trial in Early Alzheimer's Disease

Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early AD and biomarkers of elevated neuroinflammation.

Enrollment of new patients into the trial was concluded after the Company determined that there are sufficient patients currently in screening to meet the trial’s target of 201 patients. All patients currently in the screening process will remain eligible to participate in AD02, which will likely result in modest over-enrollment.

"This is a significant milestone for INmune Bio, its partners, and more importantly, for those who have participated in the study,” said CJ Barnum PhD, VP of CNS Drug Development who leads the AD02 trial. “The dedication to excellence from everyone involved in the trial has been truly remarkable.  Patient enrollment in excess of the 201-patient goal will improve the power of the trial and we greatly look forward to the final study results."

About AD02 

AD02 trial is an international, blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation – elevated CRP, HgbA1c, ESR or ApoE4 allele.  Patients receive either XPro™ or placebo (2:1 ratio) for 6 months. The cognitive endpoints are EMACC and CDR.  XPro™ is given as a once-a-week subcutaneous injection.  For more information on the AD02 clinical trial please visit www.clinicaltrials.gov or www.inmunebio.com.

About Neuroinflammation in AD

Neuroinflammation is chronic inflammation in the brain that is part of the natural aging process called inflammaging. Neuroinflammation is increased due to age, behavioral and genetic factors. Neuroinflammation has been increasingly recognized as a key contributor to the development and progression of neurodegenerative diseases, including Alzheimer's. Neuroinflammation is a key cause of nerve cell death and synaptic dysfunction that causes cognitive decline. Blocking neuroinflammation with XPro™ decreases neurodegeneration and improves synaptic function and promotes remyelination in animal models and is being tested in our Phase 2 clinical trial. There are many publications on the role of neuroinflammation in AD.  For example recent review can be found here and here.

About XPro™

XPro™ (XPro1595 or pegipanermin) is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and has a different mechanism of action than currently available TNF inhibitors in that it selectively neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ by inhibiting sTNF, a pro-inflammatory cytokine that plays a major role in driving neuroinflammation, could potentially have substantial beneficial effects in patients with neurologic disease. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation and immunology biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

Forward-Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com