Neurodegenerative disease treatment
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Alector to Host Virtual Research and Development Event Highlighting PGRN Franchise and Brain Carrier Programs
Globenewswire· 2025-09-16 12:00
Core Insights - Alector, Inc. is hosting a virtual event to discuss its progranulin (PGRN) franchise and Alector Brain Carrier (ABC)–enabled programs, focusing on therapies for neurodegenerative diseases [1] - The event will cover the pivotal Phase 3 trial of latozinemab for frontotemporal dementia and the Phase 2 trial of AL101 for early Alzheimer's disease [1] - Alector is advancing preclinical data on lead candidates for its ABC-enabled programs, including anti-amyloid beta antibody for Alzheimer's and engineered GCase-enzyme replacement therapy for Parkinson's disease [1] Company Overview - Alector is a late-stage clinical biotechnology company dedicated to developing therapies for neurodegenerative diseases, utilizing genetics, immunology, and neuroscience [3] - The company aims to remove toxic proteins, replace deficient proteins, and restore immune and nerve cell function through genetically validated programs [3] - Alector is developing the Alector Brain Carrier (ABC) platform to enhance therapeutic delivery across the blood-brain barrier, improving efficacy and patient outcomes [3]
ProMIS Neurosciences Receives DSMB Approval to Advance to Final Dose Escalation Cohort in Phase 1b Alzheimer’s Trial of PMN310
Globenewswire· 2025-09-03 11:00
Core Insights - ProMIS Neurosciences has received unanimous recommendation from the Data and Safety Monitoring Board (DSMB) to proceed to the third and final dose escalation cohort in the PRECISE-AD Phase 1b clinical trial for PMN310, aimed at treating Alzheimer's disease (AD) [2][3] - The trial is on track to enroll 128 patients and is expected to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026 [1][2] - No cases of amyloid-related imaging abnormalities (ARIA) have been observed to date, indicating a favorable safety profile for PMN310 [1][2][3] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease [5][6] - The company utilizes its proprietary EpiSelect™ platform to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [5][9] - PMN310 is a humanized IgG1 antibody designed to selectively target toxic amyloid-beta oligomers while avoiding plaque, potentially reducing ARIA liability [7][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD [8] - The trial aims to provide insights into the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [8] - The DSMB has cleared the trial to proceed to the next dosing level, increasing the dose from 10 mg/kg in the second cohort to 20 mg/kg in the final cohort [3][7] Future Outlook - The company anticipates that the ongoing clinical trials will provide critical insights into target engagement, neuronal injury, and potential disease-modifying effects of PMN310 [3][8] - ProMIS Neurosciences plans to discuss clinical progress and corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [4]
Anavex Life Sciences to Present at the H.C. Wainwright 27th Annual Global Investment Conference 2025
Globenewswire· 2025-09-02 11:30
Core Viewpoint - Anavex Life Sciences Corp. is actively engaged in developing innovative treatments for various neurodegenerative and neurodevelopmental disorders, with a focus on presenting its advancements at the upcoming H.C. Wainwright 27th Annual Global Investment Conference [1][2]. Company Overview - Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [3]. - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials, including Phase 2a and Phase 2b/3 for Alzheimer's disease, and has shown potential in treating Parkinson's disease dementia and Rett syndrome [3]. - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease progression [3]. - ANAVEX®3-71, another promising drug candidate, targets SIGMAR1 and M1 muscarinic receptors, demonstrating disease-modifying activity against Alzheimer's disease in transgenic mice [3]. Upcoming Events - Christopher U. Missling, PhD, President and CEO of Anavex, will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 1:00 p.m. ET [1][2].
Klotho Neurosciences Provides Shareholder Update Highlighting Recent Milestones as It Prepares to Address $8 Billion Neurodegenerative Disease Market
Prnewswire· 2025-08-18 12:30
Core Insights - Klotho Neurosciences, Inc. is advancing Klotho-based therapeutics for neurodegenerative diseases, targeting a market estimated at over $8 billion annually for conditions like ALS, Alzheimer's, and Parkinson's disease [1][2] Group 1: Company Achievements - In 2025, Klotho Neurosciences achieved critical strategic and operational milestones, executing a focused strategy to advance Klotho-based therapeutics from preclinical development toward clinical evaluation [2] - The company has enhanced its operational and scientific foundations through strategic partnerships, expanded research capabilities, and the addition of key talent [2] - Klotho is positioned to pursue key objectives that build on its 2025 successes, aiming to create long-term value for shareholders [2] Group 2: Product Development - Klotho Neurosciences focuses on innovative, disease-modifying cell and gene therapies derived from the human Klotho gene, targeting neurodegenerative and age-related disorders [3] - The current portfolio includes proprietary cell and gene therapy programs using DNA and RNA as therapeutics, along with genomics-based diagnostic assays [3] Group 3: Future Plans - The company plans to accelerate preclinical and IND-enabling studies for its KLTO-202 program [5] - Klotho aims to evaluate complementary technologies and acquisitions to enhance its pipeline breadth in brain health, organ function, and longevity [5] - The company will continue to expand internal capabilities to strengthen R&D, manufacturing, and clinical readiness [5]
Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights
Globenewswire· 2025-08-14 12:38
Core Insights - Clene Inc. reported its second quarter 2025 financial results, highlighting progress in its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, and confirmed sufficient cash runway into Q1 2026 [1][6]. Financial Performance - Cash and cash equivalents as of June 30, 2025, totaled $7.3 million, down from $12.2 million as of December 31, 2024 [8]. - Research and development expenses for Q2 2025 were $3.5 million, a decrease from $4.2 million in Q2 2024, attributed to cost-saving initiatives and reduced personnel expenses [9]. - General and administrative expenses were $2.4 million for Q2 2025, down from $3.3 million in Q2 2024, primarily due to decreased personnel and legal fees [10]. - Clene reported a net loss of $7.4 million, or $0.78 per share, for Q2 2025, compared to a net loss of $6.8 million, or $1.06 per share, for the same period in 2024 [12]. Clinical Development Updates - Clene is preparing for a Type C meeting with the FDA to discuss survival data from CNM-Au8 in ALS patients, with a New Drug Application (NDA) submission planned by the end of 2025 [2][4]. - The company plans to analyze neurofilament light biomarker data from its NIH-sponsored expanded access program in Q4 2025, which is crucial for supporting its NDA submission [3][6]. - Clene presented evidence of remyelination and neuronal repair in MS patients treated with CNM-Au8 at the AAN 2025 Annual Meeting, indicating significant improvements in cognition and visual function [5]. Future Plans - A second Type C meeting with the FDA is scheduled for Q3 2025 to review long-term survival benefits associated with CNM-Au8 treatment [4][6]. - Clene plans to hold an end-of-Phase 2 Type B meeting with the FDA in Q3 2025 to discuss the MS clinical development program [7].
Anavex Life Sciences to Announce Fiscal 2025 Third Quarter Financial Results on Tuesday, August 12, 2025
Globenewswire· 2025-08-05 11:30
Core Viewpoint - Anavex Life Sciences Corp. is set to release its financial results for the third fiscal quarter on August 12, 2025, and will host a conference call to discuss these results and the company's growth strategy [1][2]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various central nervous system (CNS) disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [1][4]. - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating Parkinson's disease dementia and Rett syndrome [4]. - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its ability to halt or reverse Alzheimer's disease progression [4]. - Another promising drug candidate, ANAVEX®3-71, targets SIGMAR1 and M1 muscarinic receptors and has demonstrated disease-modifying activity against Alzheimer's disease in preclinical trials [4]. Conference Call Details - The conference call will take place on August 12, 2025, at 8:30 am ET, where management will review financial results and provide updates on the company's growth strategy [2][3]. - Participants can access the call via a live webcast on Anavex's website or by dialing a specific phone number with a Meeting ID and passcode [3].
NeuroSense Provides Business Update and Progress for the First Half of 2025
Prnewswire· 2025-08-01 13:00
Core Insights - NeuroSense Therapeutics is advancing its investigational therapy PrimeC for ALS and preparing for a pivotal Phase 3 trial [2][3] - The first half of 2025 has been transformational for the company, regaining Nasdaq compliance and generating additional long-term data from its Phase 2b study [3][5] Corporate Highlights for H1 2025 - Nasdaq compliance was restored after a $5 million private placement in December 2024, strengthening the balance sheet [5] - New analyses from the Phase 2b PARADIGM study showed PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and complication-free survival by 79% [6] - Manufacturing capabilities for PrimeC were successfully scaled to commercial levels, ensuring supply chain readiness [8] Financial Results for H1 2025 - Research and development expenses decreased by 32.9% to $2,503 thousand compared to $3,733 thousand in the same period of 2024 [12] - General and administrative expenses slightly decreased by 4.4% to $2,189 thousand [12] - The net loss for the first half of 2025 was $4,709 thousand, down from $6,261 thousand in the first half of 2024 [12] Future Plans - NeuroSense plans to submit a new request for Notice of Compliance with conditions (NOC/c) in Canada, supported by additional data [11] - A multinational Phase 3 study of PrimeC is expected to commence in the second half of 2025 following positive regulatory feedback from the FDA [11] - Discussions are ongoing with a global pharmaceutical partner to advance the development and commercialization of PrimeC [11]
CervoMed Announces 32-Week Data from RewinD-LB Trial Extension Phase Showing Neflamapimod's Sustained Effect on Slowing Clinical Progression in Patients with Dementia with Lewy Bodies and Associated Reduction in a Key Plasma Biomarker of Neurodegeneration
Globenewswire· 2025-07-28 11:00
Core Insights - CervoMed Inc. announced positive results from the 32-week Extension phase of the Phase 2b RewinD-LB trial, showing that oral neflamapimod led to a 54% risk reduction in clinically significant worsening of dementia symptoms compared to control, improving to 64% for patients with minimal Alzheimer's Disease co-pathology [1][2][11] - The trial results were presented at the Alzheimer's Association International Congress 2025, highlighting the potential of neflamapimod as a treatment for Dementia with Lewy Bodies (DLB) [1][2] Clinical Trial Results - The primary endpoint, Clinical Dementia Rating Sum of Boxes (CDR-SB), showed a significant reduction in disease progression for patients treated with neflamapimod [1][2] - At Week 32, patients receiving neflamapimod demonstrated a statistically significant reduction in plasma levels of glial fibrillary acidic protein (GFAP), indicating a positive effect on neurodegeneration [1][10] - The analysis indicated that patients treated with new capsules of neflamapimod had a statistically significant slower disease progression compared to those treated with older capsules [5][10] Statistical Data - The hazard ratio for patients with ptau181 < 2.4 pg/mL was 0.46 (p=0.0037), and for those with ptau181 < 2.2 pg/mL, it was 0.36 (p=0.0001), indicating a strong correlation between lower ptau181 levels and reduced risk of clinical worsening [4][10] - A mean change in GFAP plasma levels was recorded as -18.4±4.0 pg/mL for all participants and -21.2±4.4 pg/mL for those with ptau181 < 2.2 pg/mL [10] Future Plans - CervoMed is preparing to initiate a Phase 3 trial and plans to meet with the U.S. Food and Drug Administration in Q4 2025 to discuss trial design [2][11] - The company aims to provide a meaningful treatment option for DLB patients, addressing the significant unmet needs in this area [2][11] Company Background - CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational oral small molecule targeting neurodegenerative processes [12]
Award-Winning Broadway, Television & Film Star Aaron Lazar Featuring NeuroSense CEO Alon Ben-Noon in a Special Live Podcast on ALS Science, PrimeC's Commercialization Strategies, and Community
Prnewswire· 2025-07-22 12:42
Core Insights - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, particularly ALS [12] - The company is set to unveil new insights regarding its investigational therapy PrimeC and its regulatory progress in Canada during a live broadcast event hosted by Aaron Lazar [1][2] Company Overview - NeuroSense Therapeutics is dedicated to discovering and developing therapies for neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's, which represent significant unmet medical needs [12] - The company employs a strategy of developing combined therapies that target multiple pathways associated with these diseases [12] Product Development - PrimeC, NeuroSense's lead drug candidate, is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, aimed at addressing key mechanisms of ALS [11] - The Phase 2a clinical trial for PrimeC has met safety and efficacy endpoints, showing potential in reducing functional and respiratory deterioration and demonstrating biological activity through significant changes in ALS-related biomarkers [11] Regulatory Milestones - PrimeC has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency, indicating its potential to address a rare disease with limited treatment options [11] - The upcoming live event will discuss NeuroSense's regulatory path in Canada and the latest developments regarding its binding term sheet with a pharmaceutical partner [2]
Cognition Therapeutics Publishes Proteomic Analysis Elucidating Zervimesine's Protection of Neurons and Synapses in Alzheimer's Disease
Globenewswire· 2025-07-21 11:30
Core Insights - Cognition Therapeutics, Inc. published results from the Phase 2 SEQUEL study of zervimesine (CT1812) for treating mild-to-moderate Alzheimer's disease, indicating potential neuroprotective effects and improvements in neuronal function [1][2][3] Study Findings - The SEQUEL study demonstrated that zervimesine treatment led to consistent improvements in EEG parameters, particularly a reduction in theta wave frequencies associated with Alzheimer's disease after 29 days [2][11] - Zervimesine was linked to enhanced global alpha AEC-c, indicating improved functional connectivity between brain regions, with significant protein alterations related to vesicle formation and cellular transport functions [3][4] - In vitro experiments showed that zervimesine preserved neuronal health under oxidative stress conditions, maintaining cell viability and structural integrity in the presence of 4-Hydroxynonenal (4-HNE), a known inducer of oxidative stress [5][6][7] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders, with zervimesine being a lead candidate currently in multiple Phase 2 studies [8][9] - Zervimesine has received FDA Fast Track designation for Alzheimer's disease, highlighting its potential therapeutic benefits [9][10] SEQUEL Study Details - The SEQUEL study enrolled 16 adults with mild-to-moderate Alzheimer's disease, randomized to receive either 300mg of zervimesine or placebo for 29 days, followed by a crossover to the alternate treatment [11][12]