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Bloomberg· 2025-07-28 18:26
There’s good news for older Americans at high-risk of developing dementia: simple steps to stay mentally and physically active improved thinking and helped keep Alzheimer’s disease at bay. And it didn’t take long. https://t.co/0muJ1KV7Fj ...
INmune Bio to Present Phase 2 MINDFuL Trial Findings of XPro™ at the Alzheimer’s Association International Conference
Globenewswire· 2025-07-24 11:00
Boca Raton, July 24, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) announced today 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. The presentation, to be given by Dr. Sharon Cohen, is scheduled in a Developing Topics session on Tuesday, July 29, 2025, between 2:00 and 3:30 PM ET in room 718. The MINDFuL trial ...
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
Globenewswire· 2025-06-30 11:30
Core Insights - The Phase 2 MINDFuL trial of XPro™ in early Alzheimer's Disease (AD) patients with inflammation biomarkers did not meet the primary cognitive endpoint in the modified intent-to-treat (mITT) population, but showed cognitive, behavioral, and biological benefits in a predefined subgroup of amyloid-positive patients with two or more inflammation biomarkers [1][3][4] Group 1: Trial Results - The MINDFuL trial enrolled 208 participants with early-stage AD, assessing XPro™'s potential to slow cognitive decline by targeting neuroinflammation [4] - In the predefined subgroup of amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), XPro™ demonstrated a cognitive benefit on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [7] - A biological benefit was observed in blood levels of pTau217 (effect size: -0.20), indicating a positive impact on AD pathology [7] Group 2: Safety and Tolerability - XPro™ treatment was well-tolerated and safe, with no occurrences of ARIA-E or ARIA-H reported [2][7] - The most common adverse events were injection site reactions, occurring in 80% of the XPro™ group compared to less than 20% in the placebo group [7] - There were no deaths or drug-related hospitalizations during the trial, indicating a favorable safety profile [7] Group 3: Future Plans - The company plans to submit for Breakthrough Therapy designation with the FDA and will present additional analyses at the Alzheimer's Association International Conference (AAIC) in July 2025 [2][10] - The company aims to engage regulatory authorities in the UK, EU, and other regions to define the path for a pivotal trial to support XPro™ approval in early AD [14]
Finding joy and dignity in Alzheimer’s | Lisa Groon | TEDxSioux Falls
TEDx Talks· 2025-06-13 15:39
[Music] So, these are my favorite pants. Okay, so they were my favorite pants until my mom cut the leg off. See, my mom owned a sewing business on the side.It's called Sue Sews cuz her name is Sue and she sews. I think we can all agree that's pretty adorable. She's been sewing since she was 10 years old.And in a childhood where she wasn't always valued or respected, sewing gave her dignity. It gave her joy. When my sister and I were little, she would sew us these beautiful dresses.And I remember once she se ...
The Unusual Effects Of Anavex's Blarcamesine On Alzheimer's Disease (Upgrade)
Seeking Alpha· 2025-05-15 16:21
Core Insights - Blarcamesine, a drug candidate from Anavex, shows performance comparable to Aricept in treating Alzheimer's disease, indicating limited efficacy in addressing the disease's progression [1] - The underlying causes of Alzheimer's disease are linked to oxidation and nitration, with current treatments primarily targeting symptoms rather than the root causes [1] - Natural products like panax ginseng and essential oils may offer potential benefits by inhibiting oxidative stress and reversing some damage, suggesting alternative treatment avenues [1] - Anavex and Cyclo Therapeutics are highlighted as companies with promising drug candidates in the Alzheimer's space, making them recommended investment opportunities [1] Company Analysis - Anavex's long-term open label trial results are being reassessed to understand the mechanisms of action of its drug candidate, blarcamesine [1] - The company is positioned within a niche market focused on innovative treatments for Alzheimer's, which is characterized by a need for more effective solutions [1] - Cyclo Therapeutics is also mentioned as a company with potential in developing treatments that may stabilize Alzheimer's disease [1]
Cognition Therapeutics(CGTX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 20:11
Financial Data and Key Metrics Changes - The company reported a net loss of $34 million or $0.86 per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023 [23] - Cash and cash equivalents as of December 31, 2024, were approximately $25 million, with total obligated grant funds remaining from the NIA at $50 million [20] - Research and development expenses increased to $41.7 million for the year ended December 31, 2024, from $37.2 million in 2023, primarily due to higher costs associated with completing two Phase II trials [21] Business Line Data and Key Metrics Changes - The company decided to conclude its Phase II dry AMD study before completion, reallocating resources entirely to Alzheimer's and DLB programs [11][19] - The decision to conclude the dry AMD study was based on prioritizing the success of the Alzheimer's and DLB programs, despite showing potential efficacy in dry AMD [12][13] Market Data and Key Metrics Changes - The company is actively pursuing partnerships for funding and development in the Alzheimer's and DLB space, indicating strong interest from biotech and pharma players [15] - The company has received a 6-month grace period to regain compliance with NASDAQ's minimum bid requirement, needing to maintain a stock price above $1 for 10 consecutive days before September 8, 2025 [24] Company Strategy and Development Direction - The focus remains on advancing zervimesine for Alzheimer's disease and dementia with Lewy bodies, with plans to submit final study documents to the FDA for two different end of Phase II meetings [9][10] - The company is preparing for Phase III readiness and has developed a novel chemical process for zervimesine manufacturing, with provisional patent applications filed [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in regaining NASDAQ compliance and highlighted upcoming milestones that could drive stock value [24] - The company is committed to addressing financing challenges while aiming to deliver multiple clinical milestones and create long-term shareholder value [60] Other Important Information - The company has built strong relationships with potential partners and is evaluating all options for financing clinical development efforts [15][16] - The publication process for SHIMMER data is underway, with expectations for release in the coming months [37] Q&A Session Summary Question: Thoughts on tau cutoff threshold for Phase II FDA meeting - Management plans to enrich participants in the next study for those with lower tau, similar to the SHINE study, but has not finalized the specific cutoff [29][30] Question: Feedback from investigative physicians on SHIMMER data - Management received excellent feedback from KOLs and payers, indicating a strong need for zervimesine and appreciation for its safety profile [35] Question: Competitive landscape in DLB and potential approvability - Management is confident that neuropsychiatric symptoms will be of interest to physicians and the FDA, with a focus on determining appropriate outcome measures for studies [49][50] Question: Outlook for accelerated approval in Europe vs. the US - The company plans to follow a traditional pathway for Phase III studies, as the accelerated approval process has been complex and not necessarily easier in Europe [52][53] Question: NIH funding outlook and potential for new grants - The company has a remaining balance of $50 million from NIH funding, which is expected to support ongoing trials, but anticipates lower probability for new grant funding as it progresses to Phase III [54][56]