{"id":517445,"date":"2021-07-26T08:33:35","date_gmt":"2021-07-26T12:33:35","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-inc-announces-design-of-upcoming-phase-2-alzheimers-disease-clinical-trial-and-new-phase-1b-ad-biomarker-data\/"},"modified":"2021-07-26T08:33:35","modified_gmt":"2021-07-26T12:33:35","slug":"inmune-bio-inc-announces-design-of-upcoming-phase-2-alzheimers-disease-clinical-trial-and-new-phase-1b-ad-biomarker-data","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-inc-announces-design-of-upcoming-phase-2-alzheimers-disease-clinical-trial-and-new-phase-1b-ad-biomarker-data\/","title":{"rendered":"INmune Bio, Inc. Announces Design of Upcoming Phase 2 Alzheimer\u2019s Disease Clinical Trial and New Phase 1b AD Biomarker Data"},"content":{"rendered":"
\n

\n Phase 2 study<\/em>
\n of <\/em>
\n XPro<\/em>
\n
\n TM<\/em>
\n <\/sup>
\n will be a six<\/em>
\n -month<\/em>
\n ,<\/em>
\n blinded<\/em>
\n ,<\/em>
\n randomized<\/em>
\n ,<\/em>
\n placebo-controlled trial in <\/em>
\n 168<\/em>
\n patients with <\/em>
\n m<\/em>
\n ild A<\/em>
\n lzheimer\u2019s disease<\/em>
\n and<\/em>
\n biomarkers of inflammation<\/em>
\n .<\/em>\n <\/p>\n

\n Additional analysis <\/em>
\n from the <\/em>
\n P<\/em>
\n hase 1b study<\/em>
\n of <\/em>
\n XPro<\/em>
\n
\n TM<\/em>
\n <\/sup>
\n demonstrates improvements in w<\/em>
\n hite matter <\/em>
\n analytics<\/em>
\n within <\/em>
\n three<\/em>
\n months in all patients treated with 1.0 mg\/kg which supports the dose and duration<\/em>
\n of <\/em>
\n the <\/em>
\n Phase II trial<\/em>
\n .<\/em>\n <\/p>\n

\n Recent $40 million financing provides runway <\/em>
\n to<\/em>
\n Phase 2 Alzheimer\u2019s data<\/em>
\n .<\/em>\n <\/p>\n

Boca Raton, FL, July 26, 2021 (GLOBE NEWSWIRE) — \u00a0INmune Bio, Inc. (NASDAQ: INMB) (the, \u201cCompany\u201d), a clinical-stage immunology company focused on developing treatments that harness the patient\u2019s innate immune system to fight disease, today announced the design of its upcoming Phase 2 clinical trial of XProTM<\/sup> in patients diagnosed with mild Alzheimer\u2019s disease (AD). The announcement is accompanied by the release of additional biomarker data from the Phase 1b AD trial that shows improvement in white matter (myelinated axons) that degenerate in AD patients.\u00a0\u00a0<\/p>\n

Using a novel MRI metric called Apparent Fiber Density (AFD), patients treated with 1 mg\/kg of XPro<\/em>TM<\/em><\/sup> (N=6) had increased AFD in 34 out of 35 white matter tracts. The largest improvements (>6%) were within tracts impacted by Alzheimer\u2019s disease, including the Arcuate Fasciculus (AF), where an improvement of 10% was observed by three months, an effect that persisted and increased through the last timepoint measured, nine months (+16%). AFD is a cutting-edge technique that allows for the measurement of myelinated axons that connect neurons together. The company has previously shown that the AF, a region of the brain critical for language processing, a key symptom in AD, was the white matter tract with the greatest reduction in inflammation (-40.3%).<\/p>\n

“This is the first time in my career that I have seen positive changes, and in such a short time frame. This is truly exciting,” said Maxime Descoteaux, Chief Scientific Officer at Imeka Solutions, the imaging Contract Research Organization (CRO) that has pioneered novel metrics of white matter imaging. “Apparent fiber density decreases with axonal degeneration, and this is always seen in Alzheimer’s disease patients. To see AFD increase with a therapeutic in only three months is unprecedented, especially since AFD increases the most in the locations most severely affected by Alzheimer’s pathology.”<\/p>\n

These data provide additional evidence for the previously reported improvement in CSF biomarkers of neuroinflammation, neurodegeneration, and synaptic proteins in patients treated with 1 mg\/kg of XPro<\/em>TM<\/em><\/sup> for 12 weeks. Additionally, XPro<\/em>TM<\/em><\/sup> continued to be well tolerated with no severe adverse events.<\/p>\n

\u201cIn the Phase 1b study, we demonstrated XPro<\/em>TM<\/em><\/sup> significantly decreased biomarkers of neuroinflammation in Alzheimer\u2019s patients. The data suggest that decreasing neuroinflammation results in significant improvements in biomarkers of neurodegeneration and white matter,\u201d stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. \u201cThe upcoming Phase 2 trial is designed to answer one question: if you decrease neuroinflammation and improve white matter biology in patients with mild AD, does that benefit cognition in patients with Alzheimer\u2019s disease?\u00a0We believe this trial will answer that question, and we look forward to data in 2H2023.\u201d<\/p>\n

CJ\u00a0Barnum Ph.D., Head of Neurosciences for INmune Bio, added, \u201cWe have used every lesson learned from the Phase 1b trial to design a rigorous Phase 2 study that we believe will demonstrate that the biological improvements observed following treatment with XPro<\/em>TM<\/em><\/sup> will result in a clinical benefit to AD patients.\u201d<\/p>\n

The Phase 2 study is a six-month, double-blind, randomized, placebo-controlled trial in 168 patients with mild AD who exhibit biomarkers of inflammation.\u00a0The primary endpoint will examine cognition using the Early AD\/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition (ADAS-Cog13, CDR-SB), function (ADCS-ADL, Goal Attainment Scale, NPI) and biology (MRI) will also be measured.\u00a0Patients will be randomized 2:1 (XPro<\/em>TM<\/em><\/sup>: placebo) at an XPro<\/em>TM<\/em><\/sup> dose of 1 mg\/kg once-a-week by subcutaneous injection. All patients that complete the study can enroll in an open-label 12-month extension study. Mild AD will be defined as a Clinical Dementia Rating (CDR) of 0.5 or 1.0 and patients must have at least two of the following biomarkers of inflammation: at least one ApoE4 allele, CRP >1.5mg\/L, ESR >10 mm\/h or HbA1C >6%.\u00a0The company is on track to enroll the first patient in the fourth quarter. Approximately 50 centers in North America and Australia will be opened to enroll patients. More data will be available at the INmune Bio booth on the convention floor at the Alzheimer\u2019s Association International Conference (AAIC), which is being held in a hybrid format (in person \/ virtual) from July 26-30 in Denver.<\/p>\n

\n About AAIC<\/strong>\n <\/p>\n

The Alzheimer\u2019s Association International Conference brings together the world\u2019s leading basic scientists, clinical researchers, early career investigators, clinicians and the care research community to share breaking research discoveries that will lead to methods of prevention and treatment and improvements in diagnosis for Alzheimer\u2019s disease.<\/p>\n

\n About <\/strong>
\n
\n XPro<\/em>
\n <\/strong>
\n
\n
\n TM<\/em>
\n <\/strong>
\n <\/sup>
\n (<\/strong>
\n
\n p<\/em>
\n <\/strong>
\n
\n egipanermin<\/em>
\n <\/strong>
\n )<\/strong>\n <\/p>\n

\n XPro1595 or<\/em>
\n XPro<\/em>
\n
\n TM<\/em>
\n <\/sup> is a next-generation inhibitor of tumor necrosis factor (TNF) that uses a dominant-negative TNF technology that is very different from approved TNF inhibitors that block the effects of both soluble and trans-membrane TNF. Pegipanermin neutralizes soluble TNF, without affecting trans-membrane TNF or TNF receptors. XPro<\/em>TM<\/em><\/sup> could have substantial beneficial effects in patients with Alzheimer\u2019s and other neurodegenerative diseases by decreasing neuroinflammation. 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\u2019s website.<\/p>\n

\n About INmune Bio, Inc.<\/strong>\n <\/p>\n

\n
\n INmune Bio, Inc<\/u>
\n <\/a>. 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.\u00a0The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor\u2122), cancer (INB03\u2122), Alzheimer\u2019s and Treatment Resistant Depression\u00a0(XPro<\/em>TM<\/em><\/sup>), and NASH (LIVNate\u2122). The Natural Killer Cell Priming Platform includes INKmune\u2122 aimed at priming the patient\u2019s NK cells to eliminate minimal residual disease in patients with cancer.\u00a0INmune Bio\u2019s product platforms utilize 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. To learn more, please visit\u00a0www.inmunebio.com<\/u><\/a>.<\/p>\n

\n Information\u00a0about Forward-Looking Statements<\/strong>\n <\/p>\n

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.\u00a0 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\u2122, Quellor\u2122, XPro<\/em>TM<\/em><\/sup>,<\/em> LIVNate\u2122, and INKmune\u2122 are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved 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\u2019s 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\u2019s 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\u2019s filings with the Securities and Exchange Commission, including the Company\u2019s Annual Report on Form 10-K, the Company\u2019s Quarterly Reports on Form 10-Q and the Company\u2019s 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.<\/p>\n

\n INmune Bio Contact:<\/strong>
\n
David Moss, CFO
(858) 964-3720
DMoss@INmuneBio.com<\/u><\/a><\/p>\n

\n Investor Contact:<\/strong>
\n
Chuck Padala
LifeSci Advisors
(646) 627-8390
chuck@lifesciadvisors.com<\/u><\/a><\/p>\n

\n Media Contact:<\/strong>
\n
Michael Tattory
LifeSci Communications
(646) 751-4362
mtattory@lifescicomms.com<\/a><\/p>\n<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Phase 2 study of XPro TM will be a six -month , blinded , randomized , placebo-controlled trial in 168 patients with m ild A lzheimer\u2019s disease and biomarkers of inflammation . Additional analysis from the P hase 1b study of XPro TM demonstrates improvements in w hite matter analytics within three months in all patients treated with 1.0 mg\/kg which supports the dose and duration of the Phase II trial . Recent $40 million financing provides runway to Phase 2 Alzheimer\u2019s data . Boca Raton, FL, July 26, 2021 (GLOBE NEWSWIRE) — \u00a0INmune Bio, Inc. (NASDAQ: INMB) (the, \u201cCompany\u201d), a clinical-stage immunology company focused on developing treatments that harness the patient\u2019s innate immune system to fight disease, today announced … <\/p>\n

Continue reading “INmune Bio, Inc. Announces Design of Upcoming Phase 2 Alzheimer\u2019s Disease Clinical Trial and New Phase 1b AD Biomarker Data”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-517445","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nINmune Bio, Inc. 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