New trials to evaluate IGC-AD1's potential impact on amyloid plaque, tau tangles, and cognitive decline in Alzheimer's disease
Expanded research positions IGC-AD1 as a potential treatment targeting the underlying disease pathology of Alzheimer's POTOMAC, MARYLAND / ACCESSWIRE / December 2, 2024 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment... Read more
TOKYO and CAMBRIDGE, Mass., Nov. 27, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug Safety (MFDS) approval in May 2024... Read more
First marketing authorization submission for blarcamesine NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases,... Read more
SOUTH SAN FRANCISCO, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering novel, genetically validated therapies for the treatment of neurodegenerative diseases, today announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Treatment with AL002 resulted in sustained target... Read more
Interim results indicate cognitive improvement in the active treatment group compared to placebo
No serious adverse events or deaths reported in the trial POTOMAC, Md. / Nov 25, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on agitation in Alzheimer's as its primary outcome, with cognition assessed as an... Read more
Dramatic 95% Reduction of Cognitive Decline in CT1812-treated Patients with Lower Plasma p-tau217 Correlated with Improvements in Key Indicators of Alzheimer’s Disease Biology
Findings Support Disease-modifying Potential of CT1812 PURCHASE, N.Y., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ: CGTX), a clinical-stage company developing drugs to treat neurodegenerative disorders, provided an update on a biomarker1 analysis from... Read more
Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study
Simufilam continued to demonstrate an overall favorable safety profile
Cassava intends to present the data at an upcoming medical meeting
The Company will hold a webcast today, November 25, 2024, at 8:00 AM ET AUSTIN, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc.... Read more
Candidate VY1706 demonstrates significant reductions of tau at low doses in NHP study; IND and CTA filings anticipated in 2026
VY1706 is the fifth neuro gene therapy development candidate nominated leveraging Voyager’s IV-delivered, CNS-penetrant TRACER capsids LEXINGTON, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that... Read more
Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies
At a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders
Data will guide upcoming “Lithium in Brain” Phase... Read more
TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody... Read more
Boca Raton, Florida, Nov. 13, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc.(NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease announced today that it completed randomization of patients for its Phase 2 trial on Monday, November 11th. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early... Read more
First patient randomized in SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia
Received FDA feedback on protocol for TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD)
Estimated 140 million annual acute agitation episodes associated with these conditions 1-3 NEW HAVEN, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI),... Read more
ROCHESTER, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease.
Vaccinex recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data demonstrating stage-specific biomarker and cognitive effects... Read more
Today’s presentation at CTAD, a leading international Alzheimer's conference, expands research supporting the value of ultra-low-field MRI in monitoring amyloid-related imaging abnormalities (ARIA). MADRID / Oct 31, 2024 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced... Read more
Data of Blarcamesine confirm upstream SIGMAR1 activation
Presented as Late Breaking Oral Communications at Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2024
Oral, once daily blarcamesine meaningfully slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”)... Read more
New testing method highlights link between protofibrils and biomarkers for neurodegeneration
Patient and caregiver perspectives on five-year treatment with lecanemab
Utilization of blood biomarkers to predict brain amyloid accumulation in AHEAD study of preclinical AD TOKYO and CAMBRIDGE, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,... Read more
Dose-dependent increase in neuroprotective APOE2 expression in all participants with ongoing durability at 12 months
Consistent reductions across CSF tau biomarkers and tau PET in majority of participants
LX1001 well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA)
Company to host webcast today at 7:00 AM ET NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic... Read more
A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trial
Reduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimen
Lilly intends to submit this data to global regulators for a potential label update... Read more
Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer’s disease (AD)
Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD
Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct.... Read more
Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers.
Preliminary analysis from the Phase 1/2a AD trial administering... Read more
Study met Primary and Secondary Endpoints for Safety and Regulatory T cell (Treg) Cell Population Enhancement, respectively, with no off-target effects on T effector lymphocytes, providing further evidence of target engagement Exploratory Endpoints demonstrated cognitive stabilization on treatment vs. cognitive declines on placebo for LD IL-2 dosing every 4 weeks (LD IL-2 q4wks), which was associated with significant improvement in cerebrospinal fluid (CSF) soluble... Read more
LucentADTM Complete improves on single biomarker tests, significantly reducing the intermediate zone, providing results for more patients BILLERICA, Mass. / Oct 28, 2024 / Business Wire / Lucent Diagnostics, a brand of Quanterix Corporation (NASDAQ: QTRX), has introduced LucentAD Complete, a new multi-marker blood test designed to help detect Alzheimer’s Disease (AD) in a broader range of patients.
Recent Alzheimer’s Association criteria for diagnosing Alzheimer’s... Read more
HOUSTON, TX, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced publication of a landmark study titled, “Altered Neuronal Activity Patterns of the Prefrontal Cortex in Alzheimer’s Disease After Transcranial Alternating Current Stimulation (tACS): A Resting-State Functional Magnetic Resonance Imaging Studyi” in the Journal of Alzheimer's Disease. This study builds on recent findings from... Read more
Aliada's lead compound, ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody, is a potential best-in-class therapy for Alzheimer's disease
Acquisition also allows AbbVie to utilize Aliada's novel blood-brain barrier (BBB)-crossing technology to enhance discovery and development efforts across neuroscience NORTH CHICAGO, Ill. and BOSTON, Oct. 28, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Aliada Therapeutics today announced a definitive agreement under... Read more
Vancouver, British Columbia--(Newsfile Corp. - October 28, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, announced that it has filed an additional international patent application, under the Patent Cooperation Treaty (PCT), focused on the pharmaceutical composition and method of use for the proprietary... Read more
ROCHESTER, N.Y., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present promising new efficacy and safety data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Clinical Trials on Alzheimer’s... Read more
Great Britain is the third major market where donanemab has received approval
Donanemab was first approved in the United States in July 2024 and then approved in Japan in September 2024 INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild... Read more
NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that interim data from the ongoing Phase 1/2 trial (NCT03634007) of LX1001 have been selected as a late-breaking oral presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) conference taking... Read more
HOUSTON, TX, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced results from a clinical trial demonstrating improvements in memory and cognitive function for patients with mild Alzheimer’s disease using its proprietary Deep Intracranial Frequency Stimulation (DIFS) technology. The full results have been published in Alzheimer’s Research & Therapy, one of the leading peer-reviewed journals... Read more
Data confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee
Identified dose is unlikely to require lithium therapeutic drug monitoring
Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024 ATLANTA / Oct 16, 2024 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN)... Read more
NEW YORK, Oct. 15, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative treatments, is proud to announce the granting of a U.S. patent for its pioneering Alzheimer's treatment, HT-ALZ. This milestone patent secures the company's intellectual property rights to its novel therapeutic approach, as Hoth accelerates preparations for clinical trials.
HT-ALZ represents a breakthrough in... Read more
In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint
Dalzanemdor was generally well-tolerated and no new safety signals were observed
Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year CAMBRIDGE, Mass. / Oct 08, 2024 / Business Wire / Sage Therapeutics,... Read more
APOE genotyping allows assessment of a patient’s risk for adverse effects from new anti-amyloid therapy for Alzheimer’s WALTHAM, Mass. / Oct 02, 2024 / Business Wire / Revvity, Inc. (NYSE: RVTY), announced today the launch of the in-vitro diagnostic EURORealTimeTM APOE assay in European countries that accept the CE mark, which will enable accurate genotyping of the APOE gene. APOE genotyping is valuable to assess a patient’s risk for side effects prior to the start... Read more
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early AD and biomarkers... Read more
Agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer’s disease
Extension to provide drug product (DP) manufacturing services for clinical and potential commercial supply from Lonza’s Visp, Switzerland site NEWTON, Mass., and BASEL, Switzerland, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company... Read more
Japan is the second major market where Kisunla has received approval
Kisunla was first approved in the United States in July 2024 INDIANAPOLIS, Sept. 24, 2024 /PRNewswire/ -- The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's (NYSE: LLY) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with... Read more
IGC-AD1 demonstrates the potential to modify tau and improve spatial memory
Data supports the initiation of clinical trials investigating IGC-AD1 as a treatment for Alzheimer's disease POTOMAC, Md. / Sep 18, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced data that reinforces the therapeutic potential of IGC-AD1 as a disease-modifying treatment for Alzheimer's disease. The data highlights IGC-AD1's promising... Read more
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today 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),... Read more
Early observations suggest that the vehicle-treated Alzheimer's mice exhibit a larger population of reactive astrocytes, while the HT-ALZ treated groups show fewer reactive astrocytes, pointing to a potential breakthrough in the treatment of Alzheimer's. NEW YORK, Sept. 17, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a bioph... Read more
Venlo, the Netherlands, Sept. 04, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes which can play a role in the diagnosis of Alzheimer’s disease. This collaboration represents a significant milestone as the QIAstat-Dx panel would be the first commercially available IVD for... Read more
POTOMAC, Md. / Sep 04, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease.
Following the FDA's 2023 approval of two groundbreaking anti-amyloid drugs, Donanemab (Eli Lilly) and Lecanemab (Eisai and Biogen), IGC Pharma is poised to make a significant... Read more
LIFT-AD trial did not meet primary endpoint of GST and key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23)
In pre-specified subgroups of patients with moderate Alzheimer’s disease or who are APOE4 carriers, fosgonimeton showed a numerically greater treatment effect
All biomarkers associated with Alzheimer’s disease pathology showed changes with fosgonimeton treatment consistent with the broad neuroprotective mechanism of HGF modul... Read more
IGC-1C Targets Tau Protein and GLP-1 Receptor, Offering a Multi-Pathway Approach to Neurodegenerative and Metabolic Disease Treatment POTOMAC, Md. / Aug 22, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced preclinical research demonstrating the therapeutic potential of IGC-1C, a novel small-molecule modulator. The findings show that IGC-1C targets tau protein phase separation, presenting new opportunities for... Read more
PURCHASE, N.Y., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, today announced that results from the SEQUEL study of CT1812, the Company’s lead candidate for the treatment of Alzheimer’s disease, were published in The Journal of Prevention of Alzheimer's Disease. SEQUEL was a single-site study that measured brain wave... Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1
Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito,... Read more
High bioavailability of INM-901 oral formulation provides similar drug concentration levels in the brain as intraperitoneal (IP) injection Vancouver, British Columbia--(Newsfile Corp. - August 20, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today confirms INM-901 as an oral formulation that... Read more
ROCHESTER, N.Y., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease.
Our Company recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data related to cognitive effects that may help clarify the goals... Read more
Findings from exploratory analysis of the PEGASUS trial provide preliminary evidence that AMX0035 engages multiple pathological pathways related to neurodegeneration, including tau CAMBRIDGE, Mass. / Aug 12, 2024 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of exploratory analyses on cerebrospinal fluid (CSF) biomarkers from participants with Alzheimer’s disease (AD) from the Phase... Read more
Coya had previously announced that initial topline data from this Investigator Initiated Trial (IIT) may be presented in Summer 2024. The Houston Methodist Research Institute investigators responsible for this IIT will instead be presenting the entire dataset at the CTAD24 peer reviewed medical conference in Madrid, Spain
This IIT, a double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association), evaluated the safety and tolerability,... Read more
Results affirm expectation of a novel mechanism of action targeting astrocyte activation to delay progression of Alzheimer’s disease from early stage Mild Cognitive Impairment
Findings echo previous phase 2 results in Huntington’s disease based on similarities to neuroimmune pathology in Alzheimer’s ROCHESTER, N.Y., July 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering treatment of Alzheimer’s disease... Read more
