This section highlights FDA-related milestones and regulatory updates for drugs developed by INmune Bio (INMB).
Over the past two years, INmune Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XPro1595, INB03, CORDStrom, INKmune, XPro, and AD02. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XPro1595 FDA Regulatory Timeline and Events
XPro1595 is a drug developed by INmune Bio for the following indication: Alzheimer’s disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XPro1595
- Announced Date:
- May 15, 2026
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio Inc. announced that results from its Phase 2 MINDFuL trial in Alzheimer's disease have been published in the peer-reviewed journal NPJ Dementia.
AI Summary
INmune Bio Inc. said that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study looked at XPro™, the company’s experimental treatment, in people with Alzheimer’s disease who also had signs of brain inflammation. According to the company, the published paper adds scientific support to the trial’s findings and highlights the role of inflammation in Alzheimer’s disease.
The MINDFuL trial is designed to test whether targeting inflammation can help slow disease progression and improve outcomes for patients. INmune Bio said the publication is an important step in sharing its research with the medical community and building awareness of its ongoing programs. The company hopes the data will help guide future development of XPro™ and related treatments for neuroinflammatory conditions.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- May 14, 2026
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro™ (pegipanermin), the company's first-in-class selective soluble TNF inhibitor, for the treatment of early Alzheimer's disease (AD).
AI Summary
INmune Bio Inc. said the U.S. Food and Drug Administration has given Fast Track designation to XPro™ (pegipanermin) for early Alzheimer’s disease. XPro™ is the company’s first-in-class selective soluble TNF inhibitor, and the designation is meant to help speed the development and review of treatments for serious conditions with unmet medical needs.
The company said XPro™ is designed to reduce harmful inflammation in the brain by targeting soluble TNF, a cytokine linked to neuroinflammation and neurodegeneration in Alzheimer’s disease. Unlike broader TNF blockers, it is intended to leave transmembrane TNF and its receptors untouched, which may help preserve normal immune function. INmune Bio sees this as an important step in its effort to advance a new treatment approach for early Alzheimer’s disease.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- February 12, 2026
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio, Inc. announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).
AI Summary
INmune Bio announced it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration. The minutes confirm the FDA’s feedback aligns with the company’s precision medicine plan, which uses an enrichment-led trial design to find patients whose inflammatory biomarkers link to the drug’s target, soluble TNF signaling.
Key regulatory clarity: the FDA raised no objection to using the Clinical Dementia Rating Scale–Sum of Boxes (CDR‑SB) as the sole primary efficacy endpoint for the registrational Phase 3 portion. The Agency’s review drew on INmune’s Phase 2 clinical data and biomarker analyses in the enriched population.
The FDA recommended adding an exploratory cohort of about 20% non-enriched early Alzheimer’s patients to assess broader effects. That cohort need not be independently powered, and without a treatment signal at month 9 it would not be required to continue into Phase 3.
INmune is updating its Phase 2b/3 protocol to reflect the feedback and plans to submit the protocol to the FDA, with further timeline updates to follow.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- December 1, 2025
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio, Inc. announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer's disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA.
AI Summary
INmune Bio announced new neuroimaging results from its Phase 2 MINDFuL trial of XPro1595 in people with early Alzheimer’s disease who have elevated neuroinflammation. The findings will be presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference, December 1–4, 2025 in San Diego.
Using PerpPD+, a next-generation MRI analysis that measures water diffusion perpendicular to cortical minicolumns, investigators saw a trend toward slowed neurodegeneration in patients treated with XPro1595, especially in those with high inflammatory burden and who were dose-compliant. The scans showed attenuated increases in cortical disarray, an imaging sign linked to microstructural degeneration. These imaging trends align with previously reported directional improvements on biological, cognitive, and neuropsychiatric measures. INmune Bio says additional MRI analyses are ongoing and expected in 2026.
XPro1595 selectively neutralizes soluble TNF to target innate immune dysfunction and is being studied as a potential disease-modifying therapy for the subset of Alzheimer’s patients with inflammation-driven disease.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- November 18, 2025
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio, Inc. announces two presentations at the upcoming 18th Clinical Trials on Alzheimer's Disease conference (CTAD), in San Diego, CA on December 1-4, 2025.
AI Summary
INmune Bio, Inc. announced it will present two scientific posters at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego, California, December 1–4, 2025. The company will share data from a Phase 2 study and a validation study linking cognitive measures with blood biomarkers.
The first presentation, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” is scheduled across Monday, December 1 and Tuesday, December 2, with sessions from 3:30 PM (Dec 1) to 5:30 PM (Dec 2) PT in location P057. The presenting author is Kim A. Staats, PhD, of INmune Bio.
The second presentation, “Validation of the Early Mild Alzheimer’s Cognitive Composite (EMACC) Through Associations with Blood‑Based Biomarkers of Alzheimer’s Disease,” will be on Thursday, December 4, from 7:15 AM to 5:00 PM PT in location P316, presented by Sarah Barnum, PhD, of Cognition Metrics.
INmune Bio is a clinical‑stage biotechnology company developing immunology and inflammation‑directed therapies, including programs focused on selective TNF neutralization, umbilical cord‑derived stromal cells, and natural killer cell priming.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- September 29, 2025
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio, Inc. announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial.
AI Summary
INmune Bio, Inc. has submitted a manuscript to npj Dementia detailing its Phase 2 MINDFuL trial of XPro1595 in early Alzheimer’s disease patients with inflammation. The paper, titled “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” is under peer review and available as a preprint online.
While the trial did not meet its main goal across all participants, a prespecified subgroup with both amyloid pathology and high levels of inflammatory biomarkers showed promising positive trends. These findings support the idea that targeting soluble TNF-driven neuroinflammation could benefit a specific Alzheimer’s population.
Key observations include consistent cognitive and biological improvements, along with a strong safety profile marked by no amyloid-related imaging abnormalities, even in high-risk patients like APOE4 carriers and those on blood thinners.
INmune Bio plans end-of-Phase 2 discussions with regulators and anticipates FDA feedback in the first quarter of 2026.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- March 27, 2025
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio provides a business update.
AI Summary
INmune Bio recently provided a comprehensive business update that highlighted progress across its clinical and corporate programs. The company shared key developments from its pipeline, especially in its DN-TNF platform with XPro™, designed to impact neuroinflammation in early Alzheimer’s disease patients. Interim analyses from its Phase 2 AD02 trial showed robust performance of its novel cognitive measure, EMACC, which effectively differentiated between prodromal and mild dementia stages.
The update also covered encouraging early results from the INKmune® trial in metastatic castration-resistant prostate cancer, demonstrating increased NK cell activity in patients. Additionally, INmune Bio detailed its ongoing work on CORDStrom™ for treating epidermolysis bullosa in pediatric patients, along with recent corporate financing activities and milestone achievements in supply chain and manufacturing enhancements. These advancements support the company’s strategy to advance treatments for immune and inflammatory conditions.
Read Announcement
INB03 FDA Regulatory Events
INB03 is a drug developed by INmune Bio for the following indication: INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB03
- Announced Date:
- April 16, 2026
- Indication:
- INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα
Announcement
INmune Bio Inc. announces new preclinical data for INB03 (XPro1595 for oncology). The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego on April 17-22
AI Summary
INmune Bio announced new preclinical data for INB03 (XPro1595) that will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego, April 17–22. The company will make a poster available for viewing during the meeting on April 21.
The data show that selective neutralization of soluble TNF (sTNF) by INB03 lowers MUC4 levels, which restores sensitivity to HER2-targeted therapies. INB03 also reduced tumor resistance to tyrosine kinase inhibitors (TKIs) and limited metastatic spread in models, including to the brain. Investigators say these effects help overcome key mechanisms of drug resistance in advanced HER2-positive breast cancer.
INmune Bio says the findings support broader use of INB03 across solid tumors by targeting the soluble TNF pathway and reinforce moving INB03 combinations into clinical testing for patients with TKI resistance or high risk of brain metastases.
Read Announcement
CORDStrom FDA Regulatory Timeline and Events
CORDStrom is a drug developed by INmune Bio for the following indication: For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CORDStrom
- Announced Date:
- February 19, 2026
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio Inc. a late-stage biotechnology company focused on inflammation and immunology, will host a webinar on CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) on February 26, 2026 at 1:00 p.m. ET.
AI Summary
INmune Bio Inc., a late-stage biotechnology company focused on inflammation and immunology, will host a webinar on CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB) on February 26, 2026 at 1:00 p.m. ET. Clinical investigators from the MissionEB trial will join to share real-world experience treating RDEB patients and to present new trial data.
The session will highlight the latest results from the MissionEB Phase III study and emphasize CORDStrom’s potential as a systemic, disease-modifying therapy rather than a topical wound treatment. Presentations will focus on CORDStrom’s impact on key clinical benchmarks in RDEB and the scientific rationale for treating the disease systemically.
Investigators who ran the MissionEB study in the United Kingdom will provide firsthand observations. Registration details were included in the company’s announcement; interested attendees should visit INmune Bio’s website or the original release to sign up.
Read Announcement- Drug:
- CORDStrom
- Announced Date:
- April 16, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio Inc announced a major intellectual property milestone with respect to its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™.
AI Summary
INmune Bio Inc. announced a significant intellectual property milestone for its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™. The company received a favorable written opinion from the USPTO on all claims in its international patent application PCT/US25/17028. This written opinion confirms that the claims meet the key international patent requirements of novelty, inventive step, and industrial applicability. CORDStrom™ uses pooled, culture-expanded human umbilical cord-derived MSCs, offering a promising, scalable, and consistent cell therapy option for treating a range of inflammatory and degenerative diseases. The milestone is a critical step towards securing long-term patent protection that could extend exclusivity on the technology through at least 2045. INmune Bio also plans to expedite the patent process in the U.S. via the Patent Prosecution Highway, further strengthening its intellectual property position.
Read Announcement- Drug:
- CORDStrom
- Announced Date:
- April 14, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio Inc. a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms.
AI Summary
INmune Bio Inc., a clinical-stage biotechnology company, has joined forces with the Cell and Gene Therapy Catapult to build a large-scale, commercial-ready manufacturing facility for its cell therapy platforms. This partnership will leverage the Catapult’s Stevenage Manufacturing Innovation Centre and INmune Bio’s existing setup at the Royal Free Hospital, aiming to boost the production of advanced therapies.
The initial focus is on increasing production of CORDStrom™, a promising cell therapy for treating recessive dystrophic epidermolysis bullosa (RDEB), a rare inherited skin disorder. By scaling up manufacturing, the collaboration is set to support ongoing clinical trials and prepare for future regulatory applications. This strategic move not only paves the way for broader clinical use of the therapy but also highlights the cross-border cooperation essential for advancing innovative treatments and strengthening the UK’s role in the advanced therapies industry.
Read Announcement- Drug:
- CORDStrom
- Announced Date:
- February 10, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio, announced today, following a Type C meeting with the U.S. Food and Drug Administration (FDA), its intent to submit a BLA in the US and Marketing Authorization Application (MAA) in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients.
AI Summary
INmune Bio announced plans to advance its investigational therapy, CORDStrom, following a Type C meeting with the FDA. The company intends to submit a Biologics License Application (BLA) in the US and a Marketing Authorization Application (MAA) in the UK and EU. These submissions will be supported by encouraging data from the MissionEB clinical trial, which evaluated CORDStrom as a disease-modifying treatment for pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The trial demonstrated a favorable benefit-risk profile and promising clinical effects in reducing symptoms such as itch and skin damage among children suffering from this severe genetic disorder. This regulatory effort marks a significant step towards addressing a large unmet need in treating RDEB, potentially improving the quality of life for affected young patients. Additional data may further strengthen the future approval process.
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INKmune FDA Regulatory Timeline and Events
INKmune is a drug developed by INmune Bio for the following indication: High-Risk Myelodysplastic Syndrome (MDS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INKmune
- Announced Date:
- August 4, 2025
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio Inc. is pleased to report that its Phase I/II trial (the "CaRe PC" trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment.
AI Summary
INmune Bio Inc. announced its Phase I/II trial (CaRe PC) of INKmune™ for men with metastatic castration-resistant prostate cancer met both primary and secondary goals and has closed enrollment. The primary goal showed INKmune™ was safe and well tolerated at all three dose levels.
INKmune™ treatment converts patients’ resting NK cells into memory-like NK cells that target tumor cells. Patients with low NK cell activation saw the largest biomarker improvements, defining the ideal group for future studies. More than half of participants achieved strong NK cell activation, and some experienced tumor lesions shrinking or disappearing.
Following this success, INmune Bio plans a randomized Phase 2b trial in patients with less advanced disease to better measure clinical benefit. The new study will help confirm INKmune™’s ability to boost cancer-fighting NK cells and improve patient outcomes.
Read Announcement- Drug:
- INKmune
- Announced Date:
- February 12, 2025
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio Inc. pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort.
AI Summary
INmune Bio Inc. recently announced a significant milestone in its clinical trial for the INKmune™ natural killer (NK) cell therapy aimed at treating metastatic castration-resistant prostate cancer. The company has successfully completed the third and highest dose cohort in the Phase I portion of the trial. This achievement allowed the trial to progress into the Phase II high dose cohort, where researchers can further evaluate the benefits and therapeutic potential of the higher dosage levels.
The completion of this highest dose group indicates that the treatment has maintained a strong safety profile in earlier testing. By moving into Phase II, INmune Bio intends to explore whether increased doses can enhance the immunologic effects and improve patient outcomes. This step marks an important move toward developing an effective outpatient treatment for men battling advanced prostate cancer.
Read Announcement- Drug:
- INKmune
- Announced Date:
- September 26, 2024
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio Inc. announce initial results from the first patient cohort in the trial.
AI Summary
INmune Bio Inc. announced early results from the first patient group in its Phase I/II trial testing INKmune™ for men with metastatic castration-resistant prostate cancer. The trial’s initial cohort showed that the treatment is very safe, with all patients receiving the therapy as outpatients without needing pre-medication. Even at the lowest dose, the study observed clear, lasting immune effects. Blood sample analysis from three patients revealed that INKmune™ improved the activity and function of natural killer (NK) cells. Two out of the three patients exhibited an increase in circulating activated NK cells, and all maintained enhanced NK cell function for more than 40 days after treatment. One patient experienced a temporary PSA reduction of 21%, correlating with the improved NK cell performance. These promising outcomes set the stage for the next higher-dose groups in the ongoing trial.
Read Announcement- Drug:
- INKmune
- Announced Date:
- July 23, 2024
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio announced the publication of our landmark paper in Journal Immunotherapy of Cancer co-authored by Mark Lowdell, PhD, INmune's Chief Scientific Officer, titled, " Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy."
AI Summary
In July 2024, INmune Bio announced the publication of a landmark paper in the Journal Immunotherapy of Cancer, co-authored by Chief Scientific Officer Mark Lowdell, PhD. The paper, titled “Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy,” details how their INKmune™ priming method creates memory-like natural killer (mlNK) cells with strong anti-tumor capabilities. The study showed that these mlNK cells, even when derived from cancer patients, are as effective as those from healthy donors. It provides new insights into the proteins and metabolic adaptations that help mlNK cells survive in the challenging, low-nutrient environment of tumors. Notably, it is the first study to demonstrate the in vivo generation and persistence of mlNK cells post-treatment, a promising step that supports the ongoing clinical trial in metastatic castration-resistant prostate cancer.
Read Announcement
XPro FDA Regulatory Timeline and Events
XPro is a drug developed by INmune Bio for the following indication: For treatment of Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XPro
- Announced Date:
- July 24, 2025
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio Inc announced that additional analyses from its Phase 2 MINDFuL trial evaluating XPro™, a novel selective soluble TNF inhibitor, will be released in an oral presentation at the Alzheimer's Association International Conference (AAIC) in Toronto, Canada.
AI Summary
INmune Bio Inc. announced that additional analyses from its Phase 2 MINDFuL trial of XPro™, a selective soluble TNF inhibitor, will be released in an oral presentation at the Alzheimer’s Association International Conference (AAIC) in Toronto on July 29, 2025. Dr. Sharon Cohen will deliver the data in a Developing Topics session from 2:00 to 3:30 PM ET in room 718.
The double-blind trial enrolled 208 early Alzheimer’s patients with elevated inflammation markers. Participants received XPro™ or placebo over 24 weeks, with cognitive changes measured by the Early Mild Alzheimer’s Cognitive Composite (EMACC). While the overall primary endpoint was not met, a subgroup with confirmed amyloid-beta pathology plus at least two systemic inflammation biomarkers showed consistent improvements in cognition, behavior, and Alzheimer’s-related biomarkers after six months of XPro™ treatment.
These encouraging results highlight XPro™’s potential to target neuroinflammation and slow cognitive decline. INmune Bio plans to publish full trial results by mid-August and is exploring strategic partnerships to advance XPro™ development.
Read Announcement- Drug:
- XPro
- Announced Date:
- June 30, 2025
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
AI Summary
INmune Bio announced key findings from its Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer’s disease. Although the study did not meet its primary cognitive endpoint (EMACC) in the full modified intent-to-treat group of 200 patients, a predefined subgroup of 100 amyloid-positive patients with two or more inflammation biomarkers showed notable benefits. In this subgroup, XPro™ demonstrated a positive effect on cognitive performance, behavior (as measured by the Neuropsychiatric Inventory), and a reduction in the AD biomarker pTau217 when compared to placebo.
XPro™ was generally safe and well-tolerated, including among high-risk ApoE4+/+ patients, with no observed ARIA-E or ARIA-H events. The most common side effects were mild injection site reactions. These promising findings pave the way for further analysis and potential Breakthrough Therapy Designation with the FDA.
Read Announcement- Drug:
- XPro
- Announced Date:
- June 10, 2025
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio, Inc. a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease is collaborating with Kirsty Dixon PhD, Assoc Prof. of Surgery at Virginia Commonwealth University in Richmond, Virginia on the interaction of TBI and AD. Prof Dixon and her team presented a poster at the Keystone Symposia's Neurodegeneration section: Linking Cellular Pathways to Therapeutic Strategies in Whistler, British Columbia, Canada.
AI Summary
INmune Bio, Inc., a clinical-stage inflammation and immunology company, is partnering with Dr. Kirsty Dixon, Associate Professor of Surgery at Virginia Commonwealth University, to study the link between traumatic brain injury (TBI) and Alzheimer’s disease (AD). Dr. Dixon and her team presented a poster at the Keystone Symposia’s Neurodegeneration session in Whistler, British Columbia, where they detailed their findings. Their research shows that TBI increases amyloid deposition in animal models, an effect associated with heightened AD risk. The study also revealed that treatment with INmune Bio’s XPro™ greatly reduced amyloid formation and improved overall brain function. This collaboration highlights a promising approach where targeting TBI-induced inflammation could potentially mitigate the progression of AD, paving the way for new therapeutic strategies that harness the patient’s innate immune system to combat neurodegeneration.
Read Announcement- Drug:
- XPro
- Announced Date:
- July 29, 2024
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio is pleased to be presenting results of a new and advanced proteomic analysis at this year's annual Alzheimer's Association International Conference (AAIC) in Philadelphia, PA.
AI Summary
INmune Bio is excited to present new results using advanced proteomic analysis at this year’s Alzheimer's Association International Conference in Philadelphia, PA. The study looked at changes in the cerebrospinal fluid of Alzheimer’s patients treated with XPro™, a next-generation inhibitor targeting soluble TNF. Researchers found that a 12-week treatment led to significant changes in synaptic proteins that are vital for communication between neurons. This modulation indicates that the treatment may help restore normal synaptic function, which is important because the loss of synapses is linked to cognitive decline in Alzheimer’s disease.
The findings support previous research showing that normalizing immune function can have a positive impact on neuron communication. INmune Bio’s presentation underscores the potential of XPro™ in improving synaptic health, a promising sign for therapies aimed at addressing the cell-level changes that occur in Alzheimer’s disease.
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AD02 FDA Regulatory Timeline and Events
AD02 is a drug developed by INmune Bio for the following indication: For Alzheimer Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AD02
- Announced Date:
- September 30, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio announced that that it closed enrollment for its Phase 2 trial on Friday, 27 September.
AI Summary
INmune Bio announced a key milestone in its global, blinded, randomized Phase 2 clinical trial (AD02 trial) for early Alzheimer’s disease on September 27. The company closed enrollment after confirming that there were enough patients—meeting the target of 201—to continue the study. Patients with early Alzheimer’s and biomarkers of elevated neuroinflammation are part of this trial, which is designed to test the impact of XPro™, a potential treatment to reduce brain inflammation. All patients currently in the screening process will remain eligible, which may result in a modest number of extra participants. INmune Bio sees this accomplishment as an important step forward in improving the study’s power to evaluate treatment efficacy. The announcement highlights the dedication of the research team and participants in the ongoing efforts to develop better treatments for early Alzheimer's disease.
Read Announcement- Drug:
- AD02
- Announced Date:
- September 17, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio Inc. announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint for AD trials.
AI Summary
INmune Bio Inc. announced important findings from additional analysis of blinded data in its AD02 Phase II Alzheimer’s trial. The study showed that the novel cognitive measure EMACC performed exceptionally, demonstrating a highly significant correlation (p<0.001) with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint in AD trials. This strong relationship confirms that EMACC reliably tracks cognitive changes in early Alzheimer’s patients, providing a more objective measurement compared to the CDR-SB, which was initially designed for staging rather than detecting subtle cognitive shifts.
The results support the decision to use EMACC as the primary endpoint in the trial, indicating a more precise and replicable method for evaluating cognitive function. These promising findings may lead to improved clinical trial designs and a better understanding of treatment effects in Alzheimer’s disease.
Read Announcement- Drug:
- AD02
- Announced Date:
- June 27, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio confirmed the Phase II Alzheimer's Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial's primary endpoint, the Early Mild Alzheimer's Cognitive Composite (EMACC).
AI Summary
INmune Bio confirmed that its Phase II Alzheimer’s Disease clinical trial, AD02, is appropriately powered after a blinded sample size re-estimation using the Early Mild Alzheimer’s Cognitive Composite (EMACC). A third-party team of statisticians and neuropsychologists reviewed the interim data from patients who completed the 6-month trial. Their evaluation showed that the performance of EMACC—an objective cognitive measure designed for early Alzheimer’s—is consistent with expectations, and no changes are needed in the trial’s design or size.
This careful review ensures that the trial is well-equipped to detect cognitive changes in early Alzheimer’s patients. The findings support the company’s robust, data-driven approach to tracking the effects of its treatment that targets neuroinflammation, reinforcing confidence in both the EMACC tool and the overall trial methodology.
Read Announcement
