Neurogranin

Acumen Pharmaceuticals Presents First Comprehensive Clinical and Biomarker Data for Sabirnetug (ACU193) at American Academy of Neurology 2024 Annual Meeting

Retrieved on: 
Tuesday, April 16, 2024
Science, APOE, American Academy, Brain, ABOS, Safety, Hope, Neurogranin, Poster, Plasma, Colorado Convention Center, ES2, GFAP, Patient, Incidence, AAN, CSF, Biomarker, Annual general meeting, Plaque, Cerebrospinal fluid

Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early AD.

Key Points: 
  • Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early AD.
  • Acumen remains on track to initiate the ALTITUDE-AD placebo-controlled Phase 2 trial of sabirnetug in the first half of 2024.
  • Based on safety, target engagement and biomarker data from the INTERCEPT-AD trial, Acumen has determined sabirnetug doses of 35 mg/kg Q4W and 50 mg/kg Q4W in ALTITUDE-AD.
  • Acumen also plans to initiate a Phase 1 bioavailability study to support a subcutaneous dosing option of sabirnetug in mid-2024, as announced in November 2023 .

Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2023 and Business Highlights

Retrieved on: 
Tuesday, March 26, 2024
Research, Toxicity, Central nervous system, PIN, Administration, Immunotherapy, Emax, Science, Patient, AstraZeneca, Food and Drug Administration, Biomarker, G&A, Plaque, Chemistry, Therapy, Neurogranin, Safety, ABOS, Research and development, Plasma protein binding, Food, Pharmaceutical industry

We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.

Key Points: 
  • We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.
  • We also expect to initiate a subcutaneous bioavailability study in mid-2024, to extend the product profile and offer administration optionality for patients.
  • Dr. Doherty brings decades of neuroscience-focused research and clinical development expertise to Acumen, from discovery through drug approval.
  • Net loss for the year ended December 31, 2023 was $52.4 million, compared to a net loss of $42.9 million for the year ended December 31, 2022.

Acumen Pharmaceuticals Presents Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting

Retrieved on: 
Friday, March 8, 2024
ABOS, Immunotherapy, Pathology, Cerebrospinal fluid, Plaque, Neurogranin, Conference, Biomarker, DSM-IV codes, Disease, Trial of the century

CHARLOTTESVILLE, Va., March 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today presented cerebrospinal fluid (CSF) biomarker data from the sabirnetug (ACU193) Phase 1 INTERCEPT-AD trial in an oral presentation at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Lisbon, Portugal, and online. Acumen also presented a poster showcasing the method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody.

Key Points: 
  • Acumen also presented a poster showcasing the method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody.
  • Acumen’s sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration.
  • Positive topline results from 62 participants dosed in the Phase 1 INTERCEPT-AD trial (NCT04931459) were reported in July 2023 , and additional insights from exploratory analyses have further confirmed sabirnetug’s proof-of-mechanism and broad therapeutic potential as a next-generation treatment for early AD.
  • The novel assay configuration was tailored to selectively detect sabirnetug-AβO complex in CSF as a direct measure of target engagement, showing clear dose-related increases in target engagement across all cohorts.

Acumen Pharmaceuticals to Present Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting

Retrieved on: 
Wednesday, February 21, 2024
ABOS, Immunotherapy, Pathology, Neurogranin, USAN, Conference, Safety, Biomarker, DSM-IV codes, Pharmaceutical industry

CHARLOTTESVILLE, Va., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that it will be presenting biomarker data and target engagement methods in an oral and poster presentation, respectively, at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD), taking place March 5-9, 2024, in Lisbon, Portugal, and online.

Key Points: 
  • Acumen’s sabirnetug (ACU193) is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration.
  • Positive topline results from 62 participants in the Phase 1 INTERCEPT-AD trial (NCT04931459) showed sabirnetug to be well-tolerated with a favorable overall safety profile.
  • Effects of sabirnetug on both neurogranin and pTau181 levels in CSF in this Phase 1 study are consistent with downstream pharmacologic effects of the drug.
  • Presentation details as follows:
    Sabirnetug is the nonproprietary name for ACU193 accepted by USAN and INN.

ZyVersa Therapeutics Announces Peer-Reviewed Article Supporting the Therapeutic Potential of Targeting ASC Specks During Progression of Alzheimer’s Disease

Retrieved on: 
Wednesday, January 24, 2024
Pathology, Death, Patient, ASC, Therapy, Multiple sclerosis, Neuron, Memory, DSM-IV codes, University, Physiology, Microbiology, Immunology, Neurogranin, Central nervous system, Microglia, Inflammation, Brain, Invention, Pharmaceutical industry

WESTON, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, is pleased to announce that world renowned inflammasome researchers and inventors of ZyVersa’s Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Key Points: 
  • ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC specks to block initiation and perpetuation of damaging inflammation in the central nervous system and peripheral tissues.
  • WESTON, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc .
  • Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President, commented, “The research published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions reinforces the therapeutic potential of ZyVersa’s Inflammasome ASC Inhibitor IC 100 in neurological diseases.
  • Preclinical studies have demonstrated reduced inflammatory activity and/or improved outcomes in multiple sclerosis, age-related inflammation, spinal cord injury, and two different models of brain injury.”

ProMIS Neurosciences Announces Third Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, November 14, 2023
Acumen, Neurogranin, Research, Safety, Food, AAIC, Incidence, ALS, Immunoglobulin G, Translational neuroscience, PROMIS, CSF, Patient, MSA, Pharmacokinetics, ITN, Immunization, Therapy, Blood, Neuroscience, ARIA, PMN, Biomarker, Cerebrospinal fluid, Multiple system atrophy, Initiative, Lecanemab, Pharmaceutical industry, Cryptocurrency, Boston

CAMBRIDGE, Massachusetts, Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “The third quarter was marked by significant progress across both our clinical and corporate initiatives,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences.
  • These results replicated biomarker findings from the CLARITY-AD trial of lecanemab, which also predominantly targets soluble amyloid beta oligomers.
  • In July 2023, the Company presented preclinical data from mouse vaccination studies at AAIC 2023.
  • Net loss was $2.4 million for the quarter ended September 30, 2023, compared to a net loss of $6.0 million for the same period in 2022.

Acumen Pharmaceuticals Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Monday, November 13, 2023
Neurogranin, Plasma, CSF, PIN, Administration, Patient, Research, FDA, Caregiver, Pharmacology, Halozyme, ABOS, Cash balance plan, Clinical trial, R, Research and development, Biomarker, Pharmaceutical industry, Vaccine, Cryptocurrency, G&A, Acumen

ET

Key Points: 
  • ET
    CHARLOTTESVILLE, Va., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today reported financial results for the third quarter of 2023 and provided a business update.
  • “We have also observed encouraging trends in CSF biomarker data from our Phase 1 study, further solidifying the pharmacology of ACU193.
  • In October 2023, the Company met with the FDA to discuss the next clinical trial in the development program for ACU193.
  • Acumen will host a conference call and live audio webcast today, Nov. 13, 2023, at 8:00 a.m.

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Thursday, July 20, 2023
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This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Thursday, July 20, 2023
PK, GFAP, Glial fibrillary acidic protein, Clinical trial, SC, Biogen, The New England Journal of Medicine, BIIB, Pathology, PET, Brain, Biomarker, Clarity, Plasma, Eisai, AAIC, Fluid mechanics, Amyloid, Headquarters, Corporation, Astrocyte, Neurogranin, Lecanemab, AD, FDA, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical imaging, Pharmaceutical industry, Alzheimer's disease, CSF

TOKYO and CAMBRIDGE, Mass., July 19, 2023 /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 results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI®) treatment showed reductions in amyloid-beta (Aβ) pathology and downstream biomarker changes. This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • These outcomes suggested lecanemab impacts A/T/N+ biomarkers involved in the AD pathophysiology and exerts biological effects that demonstrate slowing of disease progression.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

USPTO Issues Notice of Allowance to BRAINBox Solutions to Grant Broad U.S. Patent Covering Biomarkers that Correlate to MRI Neuroimaging Findings

Retrieved on: 
Friday, March 17, 2023
DSM-IV codes, National Center for Telehealth & Technology, Patent, Concussion, ALDOC, Nerve injury, SBIR, ATE, Long-term care, Pathology, Brain, TBI, Biomarker, Aldolase C, MRI, Initial, NRGN, Patient, Risk, Algorithm, Diagnosis, Brainbox, Geriatrics, Conditional sentence, Medical imaging, Stroke, Neurogranin

RICHMOND, Va., March 17, 2023 /PRNewswire/ -- BRAINBox Solutions today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance to issue to the company a broad patent covering a specific set of biomarkers that correlate to specific neuroimaging findings by standard or advanced MRI methods. The patent is part of the company's extensive and growing intellectual property portfolio covering the use of novel biomarkers in combination with functional tests to diagnose individuals with concussion (mild traumatic brain injury or acute traumatic encephalopathy, ATE) and assess their risk of chronic injury.

Key Points: 
  • RICHMOND, Va., March 17, 2023 /PRNewswire/ -- BRAINBox Solutions today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance to issue to the company a broad patent covering a specific set of biomarkers that correlate to specific neuroimaging findings by standard or advanced MRI methods.
  • "This new patent, and our broader portfolio, underlie the BRAINBox TBI family of diagnostic/prognostic point-of-care or main lab delivered tests we are developing for ATE," said Donna Edmonds, CEO of BRAINBox Solutions.
  • The Initial BRAINBox ATE test will include a panel of blood biomarkers and a battery of neurocognitive tests, combined in an easy-to-use application.
  • The new patent will cover the use of eight biomarkers, including Aldolase C (ALDOC) and Neurogranin (NRGN).