MMSE

Coya Therapeutics (Coya) Announces Completion of Enrollment in a Well-Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease (AD)

Retrieved on: 
Monday, October 9, 2023
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A total of 38 patients were randomly assigned to receive subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks.

Key Points: 
  • A total of 38 patients were randomly assigned to receive subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks.
  • Coya previously reported that the treatment with LD IL-2 significantly expanded Treg population and function in an open-label proof-of concept study in 8 patients with AD.
  • Overall, administration of LD IL-2 appeared to be well tolerated in the 8 patients in the open-label, proof-of concept study.
  • No serious adverse events were reported, and no patient discontinued the study.

BrainCheck to Showcase Comprehensive Cognitive Health Platform at Hint Summit 2023, the Premier Direct Primary Care (DPC) Innovation Conference

Retrieved on: 
Tuesday, September 19, 2023
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AUSTIN, Texas, Sept. 19, 2023 /PRNewswire/ -- BrainCheck today announced it will showcase its comprehensive cognitive health platform at Hint Health's Hint Summit event, taking place September 20-23 in San Diego, CA during World Alzheimer's Month and Healthy Aging Month. Attendees are invited to visit the BrainCheck booth #5 to see the company's digital cognitive assessment and care management solutions in action and learn how leading clinicians nationwide are overcoming the limitations of outdated cognitive tests to enhance clinical insights and elevate patient care.

Key Points: 
  • "Following the announcement of our partnership with Hint Health earlier this year, we are thrilled to share our clinically-proven cognitive health platform with the growing direct primary care community at Hint Summit."
  • "With solutions spanning the complete cognitive care continuum, BrainCheck is at the forefront of the cognitive health revolution, enabling earlier detection and personalized intervention for patients," said Zak Holdsworth, CEO and Co-Founder of Hint Health.
  • Ecosystem partners like BrainCheck are integral to this strategy and we're thrilled to highlight the platform at this year's Hint Summit."
  • Hint Health is the leading digital health company dedicated to supporting the growth and success of the DPC movement.

BioVie Presents Data Highlighting Baseline Characteristics of Study Population in Phase 3 Trial of NE3107 in Mild to Moderate Alzheimer’s Disease

Retrieved on: 
Monday, September 11, 2023
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CARSON CITY, Nev., Sept. 11, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that preliminary baseline data from its multicenter, randomized, placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients with mild to moderate Alzheimer’s Disease (AD) was presented as a poster at the American Neurological Association (ANA) annual meeting, being held September 11-13, 2023 in Philadelphia, PA.

Key Points: 
  • The poster, Metabolic Dysregulation in Probable Alzheimer’s Disease (Christopher Reading, et al), is being presented by Joseph Palumbo, Chief Medical Officer of BioVie, and highlights the preliminary baseline metabolic and inflammation characteristics from the Phase 3 study population (see Table 1).
  • “Instead, it provides an understanding of the patient population at the start of the trial, as understood to date.
  • At baseline, the majority of the study population are coded with abdominal obesity (85%), hypertension (61%), and impaired glucose metabolism (IFG/T2D; 52%).
  • Both Aβ+ and Aβ− patients with dementia were enrolled in the study and had, at baseline, comparable CDR-SB scores indicative of mild dementia.

Alzheon Reports Industry-Leading Biomarker, Brain Preservation and Clinical Benefits Following 24 Months of Treatment in Phase 2 Trial of Oral ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer’s Disease

Retrieved on: 
Wednesday, September 13, 2023
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“We are pleased with the growing body of evidence that supports ALZ-801’s potential as the first oral disease modifying therapy for Alzheimer’s disease.

Key Points: 
  • “We are pleased with the growing body of evidence that supports ALZ-801’s potential as the first oral disease modifying therapy for Alzheimer’s disease.
  • In mechanism of action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid (Aβ) oligomers at the Phase 3 clinical dose.
  • In November 2022, Alzheon reported positive study results from a pre-specified analysis following 52 weeks of treatment with ALZ-801.
  • An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 52 weeks of treatment for a total of 156 weeks.

Coya Therapeutics Reports Additional Biomarker and Imaging Data Showing Decrease in Neuroinflammation with COYA 301 in Alzheimer's Disease

Retrieved on: 
Wednesday, June 7, 2023
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- Furthermore, Coya reports a case study of a patient in the COYA 301 trial who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation.

Key Points: 
  • - Furthermore, Coya reports a case study of a patient in the COYA 301 trial who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation.
  • Meaningful reductions in neuroinflammation were observed throughout the cerebral cortex including hippocampal regions following treatment with COYA 301, which correlated with improvement in cognitive function in this patient.
  • The patients were treated with five day-courses of COYA 301 for four monthly cycles and were followed for two months post-treatment.
  • "We believe these additional data further support our Treg-focused approach to develop safe and effective treatments for neurodegenerative diseases of high unmet need.

Vaxxinity Announces Publication of UB-311 Safety, Tolerability, Immunogenicity, and Clinical Efficacy Data from Phase 2a Trial in Alzheimer’s Disease

Retrieved on: 
Thursday, August 10, 2023
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CAPE CANAVERAL, Fla., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today announced the print publication of Phase 2a clinical trial data in The Lancet’s eBioMedicine (Volume 94, 104665, August 2023), stating that UB-311 “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).

Key Points: 
  • UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.
  • The Phase 2a data, which have been previously disclosed, describe the safety, tolerability, immunogenicity, and early clinical efficacy of UB-311 when evaluated with quarterly or biannual booster doses.
  • The gradual, natural titration of antibody titers through this approach may have contributed to a lack of ARIA-E in this study.
  • The publication titled, “Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study,” is available online here .

Coya Therapeutics, Inc. Provides Business Update and Reports Q2 2023 Unaudited Financial Results

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Tuesday, August 8, 2023
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Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), today announced its financial results for the second quarter ended June 30, 2023, and provided a clinical and business update.

Key Points: 
  • Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), today announced its financial results for the second quarter ended June 30, 2023, and provided a clinical and business update.
  • Study data were presented at the 2023 Keystone Symposia Neurodegeneration: Biology Guiding the Next Generation of Therapeutic Development.
  • COYA 301 is Coya’s proprietary ld IL-2 formulation that is intended to enhance anti-inflammatory regulatory T cell function and numbers.
  • The Company expects general and administrative costs to continue to grow in 2023 as Coya expands its business development activities as well as incur additional public company costs.

BioVie Issues Letter to Shareholders

Retrieved on: 
Tuesday, July 18, 2023
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Over 3,000 significant correlations were found linking reductions in DNA methylation of various CpGs and cognitive, biomarker and neuroimaging endpoints.

Key Points: 
  • Over 3,000 significant correlations were found linking reductions in DNA methylation of various CpGs and cognitive, biomarker and neuroimaging endpoints.
  • I have prepared this letter to shareholders to provide an update that synthesizes all the information that we have released and presented at recent medical conferences.
  • NE3107 reduced CSF phospho-tau levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to amyloid beta 42 (Aβ42) by -0.0024 (p=0.0401).
  • P-tau and Aβ are traditional biomarkers of AD progression and have been the focus for AD researchers for decades.

Cognito Therapeutics Presents New MRI Data Showing Non-Invasive Gamma Stimulation Therapy Reduces Brain Atrophy and Myelin Loss in Alzheimer’s Disease

Retrieved on: 
Monday, July 17, 2023
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“Our Phase 2 study demonstrated that Cognito’s proprietary disease-modifying therapy reduced brain atrophy and myelin loss in Alzheimer’s patients.

Key Points: 
  • “Our Phase 2 study demonstrated that Cognito’s proprietary disease-modifying therapy reduced brain atrophy and myelin loss in Alzheimer’s patients.
  • Daily use of the Gamma Sensory Stimulation System was confirmed to be safe with minimal side effects.
  • “Our Phase 2 OVERTURE study results continue to demonstrate that daily, proprietary gamma sensory stimulation is safe and well tolerated,” said Brent Vaughan, CEO, Cognito Therapeutics.
  • “Patients in the active arm demonstrated a reduction in decline in functional and cognitive abilities, and showed reduced brain atrophy.

NKGen Biotech Presents Interim Phase I Trial Data at 2023 Alzheimer’s Association International Conference

Retrieved on: 
Monday, July 17, 2023
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Subjects received one of three doses of SNK01 (1 x 109 cells, 2 x 109 cells, or 4 x 109 cells).

Key Points: 
  • Subjects received one of three doses of SNK01 (1 x 109 cells, 2 x 109 cells, or 4 x 109 cells).
  • “We are very pleased with the interim results from our Phase I trial,” said Dr. Paul Y.
  • Based on the interim data, no related serious adverse events were observed, and a dose-limiting toxicity was not reached.
  • A SNK01 dose-response was observed, as indicated by cognitive improvement and protein and inflammation markers (CDR-SB, MMSE, pTau181, GFAP and YKL-40).