INmune Bio, Inc. Receives Health Canada “No Objection Letter” to Commence Clinical Trial of XPro1595 in Mild Alzheimer’s Disease
INmune Bio has received a "No Objection Letter" from Health Canada to commence its Phase II trial using XPro1595 for mild Alzheimer’s Disease. This approval enables patient enrollment in Canada, joining ongoing efforts in Australia and awaiting clearance from the FDA for U.S. participation. The first patient has finished dosing and is enrolled in an extension study. XPro1595 works by inhibiting soluble tumor necrosis factor, potentially reducing neuroinflammation and improving cognition in patients.
- Health Canada issued a "No Objection Letter" for the Phase II trial of XPro1595.
- Enrollment in Canada and Australia increases patient population and trial pace.
- The first patient has completed dosing and enrolled in an open-label extension study.
- The trial is still on hold in the U.S. pending FDA clearance.
BOCA RATON, FL., Nov. 14, 2022 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces that Health Canada has issued the Company a “No Objection Letter” to proceed with the Company’s trial using XPro1595 to treat mild Alzheimer’s Disease (AD) in Canada.
“We are pleased that Canada is now part of this international Phase II trial,” said Dr. RJ Tesi, CEO of INmune Bio. “Enrolling patients in both Canada and Australia gives us access to a larger patient population that should help increase the pace of enrollment. We hope to further expand the geographical footprint of the trial soon.”
The first patient in the Phase 2 trial recently completed all dosing and has enrolled in an open-label extension study in Australia. While the Company continues to collaborate with the FDA’s review of the trial to release its current hold and initiate enrollment in the U.S., it is now working to setup sites and enroll additional patients in Canada.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, improving axonal quality and synaptic function while promoting remyelination. 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 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™), Mild Alzheimer’s disease, Mild Cognitive Impairment 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, 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, CFO (858) 964-3720
info@inmunebio.com
Investor Contact: Jason Nelson
Core IR
(516) 842-9614 x-823
FAQ
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