Neurodegenerative disease treatment

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Alterity Therapeutics Presents Positive Data from ATH434 Phase 2 Trial at the 2025 International Congress of Parkinson’s Disease and Movement Disorders
Globenewswire· 2025-10-09 11:25
– Data demonstrate ATH434 slows disease progression and stabilizes orthostatic hypotension – – New analysis increases overall confidence in the Phase 2 trial results – – State-of-the-art neuroimaging and biomarker analysis advance understanding of MSA diagnosis – MELBOURNE, Australia and SAN FRANCISCO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerati ...
Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International Congress of Parkinson’s Disease and Movement Disorders
Globenewswire· 2025-10-02 11:35
Core Insights - Alterity Therapeutics is set to present data from its ATH434-201 Phase 2 clinical trial for Multiple System Atrophy (MSA) at the 2025 International Congress of Parkinson's Disease and Movement Disorders [1][2] Company Overview - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly MSA and Parkinson's disease [4][8] - The company has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial [8] ATH434 Details - ATH434 is an oral agent designed to inhibit the aggregation of pathological proteins involved in neurodegeneration, specifically targeting α-synuclein pathology [4] - Preclinical studies have shown that ATH434 can reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain [4] - The drug has received Fast Track Designation and Orphan Drug Designation from the FDA for the treatment of MSA [4] ATH434-201 Phase 2 Clinical Trial - The ATH434-201 trial was a randomized, double-blind, placebo-controlled study involving 77 adults, assessing the efficacy, safety, and pharmacokinetics of ATH434 over 12 months [5][6] - Results indicated that ATH434 led to clinically and statistically significant improvements on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I compared to placebo [6] - Wearable sensors were used to evaluate motor activities, showing increased activity in outpatient settings for those receiving ATH434 [6] Presentation Details - The data will be presented in an oral session titled "ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy" by CEO David Stamler on October 8, 2025 [3] - Additional poster presentations will cover topics such as the relationship between α-synuclein aggregation profiles and disease severity, and differences between clinical and imaging phenotypes in MSA [3]
Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International Congress of Parkinson's Disease and Movement Disorders
Globenewswire· 2025-10-02 11:35
– Data from ATH434-201 double-blind Phase 2 trial to be featured in oral session and multiple poster presentations – MELBOURNE, Australia and SAN FRANCISCO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) will b ...
Anavex Life Sciences Announces Positive Topline Results from Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia
Globenewswire· 2025-10-02 11:30
ANAVEX3-71-SZ-001 achieved its primary endpoint demonstrating safety and tolerability in adults with schizophrenia Encouraging trends observed in biomarkers support continued development NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, today announced positive topline res ...
Annovis Appoints Mark Guerin as Chief Financial Officer
Globenewswire· 2025-09-25 11:30
Core Viewpoint - Annovis Bio, Inc. has appointed Mark Guerin as Chief Financial Officer to guide the company through a critical phase as its drug candidate, buntanetap, shows promise in late-stage clinical development for neurodegenerative diseases [1][5] Company Overview - Annovis Bio is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease [1][6] - The company is headquartered in Malvern, Pennsylvania, and is dedicated to improving patient outcomes and quality of life through innovative therapies [6] Leadership Experience - Mark Guerin has extensive experience in financial operations within biopharma companies, having served as CFO at Onconova Therapeutics (now Traws Pharma) and facilitated critical financing transactions [2][3] - Prior to Onconova, Guerin held senior finance roles, including Vice President of Finance and CFO at Cardiokine, Inc., overseeing its New Drug Application filing and sale [3][4] Financial Strategy - During his tenure at Onconova, Guerin was instrumental in completing several financing transactions, including a $20 million financing in December 2024 [2] - His experience includes managing financial reporting, forecasting, and internal controls, which will be beneficial for Annovis as it advances its clinical programs [2][5]
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].