Alzheimer’s disease patients treated with – GuruFocus.com
Company to present additional data from Phase 1b during webinar on September 7e, 2021 at 4:30 p.m. EST.
Boca Raton, FL, September 01, 2021 (GLOBE NEWSWIRE) – INmune Bio, Inc. (INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the innate immune system of the patient to fight the disease, today announced that XPro ™ (pegipanermine), the Company’s selective DN-TNF inhibitor candidate for the treatment of Alzheimer’s disease (AD), treatment-resistant depression and other neurological diseases where neuroinflammation is involved, has been shown to decrease several Phospho Tau species (pTau) and improve neuroimaging biomarkers of myelination in patients with AD.
These biomarker data come from the analysis of the company’s Phase 1 study of XPro ™ in patients with Alzheimer’s disease, which has just been completed. Patients with AD treated with 1.0 mg / kg XPro ™ once weekly for three months experienced a 46% reduction in pT217 CSF (p
“CSF pT217 appears to be the most sensitive tau biomarker of neurodegeneration in patients with AD, and our data show that control of neuroinflammation decreases pT217,” said CJ Barnum, PhD, head of neuroscience for INmune Bio. “Tau pathology has been associated with decreased white matter integrity in AD and we believe these data are consistent with our biomarkers for measuring white matter pathology in patients with AD. White matter pathology begins early, changes are measurable and appear to reverse after treatment with XProMT. “
The Company also reported improved white matter MRI parameters, including a 16% improvement in radial diffusivity, a biomarker of remyelination. These data are in addition to previously reported improvements in fiber bulk density (axonal integrity) and free water (neuroinflammation). In each measure, improvements continued throughout the 12-month extension trial (the last time point evaluated).
“Data from this Phase I trial show that XPro ™ decreases biomarkers of neuroinflammation and nerve cell death while improving biomarkers of neuroreparation in AD patients,” said RJ Tesi, MD, CEO of INmune Bio. “We can now add improvements in neuroimaging biomarkers of remyelination to the beneficial effects of XProMT in these patients. In our next Phase 2 trial, we hope to demonstrate that when XProMT decreases neuroinflammation and neurodegeneration, improves axonal quality and promotes remyelination, there will be a measurable benefit on the patient’s cognitive function.
The Company plans to begin enrolling a phase 2, randomized, blinded trial in patients with mild AD by the end of 2021. The six-month trial will enroll 200 patients at centers in North America and Australia. Patients will receive 1 mg / kg XProMT weekly by subcutaneous injection. The primary endpoint is EMACC (Early AD / Mild Cognitive Impairment Alzheimer’s Cognitive Composite), a sensitive measure of cognitive function.
INmune Bio management will host an investor webinar to further examine these results and additional data from Phase 1b. Details of the webinar are available below:
Investor webinar details
Date: September 7, 2021
Time: 4:30 p.m. ET
Registration link: (Click on here) Where: https://us06web.zoom.us/webinar/register/WN_IlMwrkPGRa63319QM91YFg
About Xpro ™ (pegipanermine)
Xpro ™ (formerly Xpro1595) is a next generation tumor necrosis factor (TNF) inhibitor that uses dominant negative TNF technology that is very different from approved TNF inhibitors that block the effects of soluble and transmembrane TNF. Xpro ™ neutralizes soluble TNF, without affecting transmembrane receptors for TNF or TNF. Xpro ™ could have substantial beneficial effects in patients with Alzheimer’s disease and other neurodegenerative diseases by decreasing neuroinflammation. For more information on the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neural communication, visit this section from the INmune Bio website.
About INmune Bio, Inc.
INmune Bio, Inc. is a publicly traded, clinical-stage biotechnology company (INMB) focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms. The DN-TNF product platform uses dominant negative technology to selectively neutralize soluble TNF, a key factor in innate immune dysfunction and a mechanistic target for many diseases. DN-TNF is currently under development for complications of COVID-19 (Quellor ™), cancer (INB03 ™), Alzheimer’s disease and treatment-resistant depression (Xpro ™). The Natural Killer Cell Priming Platform includes INKmune ™ aimed at priming patient NK cells to eliminate minimal residual disease in cancer patients. INmune Bio’s product platforms use a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation with components of the innate immune system. For more information, please visit www.inmunebio.com.
Information on forward-looking statements
Clinical trials are still in their infancy and there is no guarantee that a specific result will be achieved. All statements in this press release that do not describe historical facts may constitute forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not not describe historical facts may constitute forward-looking statements. Forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. All forward-looking statements contained in this document are based on current expectations but are subject to a number of risks and uncertainties. The actual results and timing of certain events and circumstances may differ materially from those described in forward-looking statements due to these risks and uncertainties. INB03 ™, Quellor ™, Xpro ™, LIVNate ™ and INKmune ™ are still undergoing clinical trials or preparing to start clinical trials and have not been approved and there can be no assurance that they will be approved or that any results will be obtained. specific will be obtained. 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 drugs for clinical trials; the availability of substantial additional financing for the Company to continue its operations and conduct research and development activities, clinical studies and future product marketing; 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 current company reports on Form 8. -K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this press release.
INmune bio contact:
David Moss, Chief Financial Officer