Amyloid

Prothena Reports First Quarter 2024 Financial Results and Business Highlights

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星期三, 五月 8, 2024
Research, Finance, Clinical Trials, Professional Services, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Amyloid, Mortality, FDA, License, Fast Track, TTR, ATTR, Organ dysfunction, Risk, Food, Amyloidosis, Orphan, Epitope, Partnership, IND, Roche, Culture, Therapy, Novo Nordisk, Patient, Acquisition, Failure, VITAL, Bristol Myers Squibb, Clinical trial, European Medicines Agency, Overalls, Pharmaceutical industry

Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the first quarter of 2024 and provided business highlights.

Key Points: 
  • Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the first quarter of 2024 and provided business highlights.
  • For the first quarter of 2024, Prothena reported a net loss of $72.2 million, as compared to a net loss of $46.9 million for the first quarter of 2023, respectively.
  • Prothena reported total revenue of $0.1 million for the first quarter of 2024, as compared to total revenue of $2.2 million for the first quarter of 2023.
  • Research and development (R&D) expenses totaled $64.1 million for the first quarter of 2024, as compared to $44.8 million for the first quarter of 2023.

NKGen Biotech Presents Updated NK Cell Therapy Data for Neurodegenerative Disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit

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星期四, 四月 25, 2024
Amyloid, Pure autonomic failure, Protein, GDF15, Cell, Safety, AFL, Median, Neuroinflammation, Fluid mechanics, Corticobasal degeneration, Cytokine, Plasma, MD, Dementia, Latency, GFAP, IND, Frontotemporal dementia, Patient, Multiple system atrophy, UK Biobank, CSF, ADAS-Cog, Biomarker, Clinical trial, PD, NK, LTBP2, Pharmaceutical industry

90% of patients enrolled in the proof-of-concept Phase 1 Alzheimer’s trial had improved or stable cognitive function at week 11 using the composite ADCOMS score.

Key Points: 
  • 90% of patients enrolled in the proof-of-concept Phase 1 Alzheimer’s trial had improved or stable cognitive function at week 11 using the composite ADCOMS score.
  • NKGen submitted an IND for SNK01 in Parkinson’s disease (“PD”) in Q1 2024 and anticipates to begin enrollment for its Phase 2 trial in advanced Alzheimer’s disease (“AD”) in Q2 2024.
  • Cognitive assessments and extensive CSF/plasma biomarker analyses were performed at baseline and at 1 and 12 weeks after the final dose.
  • A larger Phase 2 placebo-controlled AD trial with a higher dosing and longer duration will begin to enroll in Q2 2024.

Cognition Therapeutics KOL Event Provided Platform for Valuable Discussion of Current Therapeutic Options and Need for Additional Options to Treat Alzheimer’s Disease

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星期一, 四月 22, 2024
Amyloid, Alzheimer's disease, Jort, University, MCI, Inflammation, Oxidative stress, ARIA, News, Research, Neuroinflammation, Cognition, Doctor of Philosophy, ADAS, START, KOL, Patient, SHINE, Perception, Neuron, Antibody, Therapy, Plaque, Cerebrospinal fluid

“The KOL roundtable we conducted featured a panel of Alzheimer’s disease expert clinicians and researchers who highlighted the need to find Alzheimer’s disease treatments that are less burdensome for patients and their care partners,” said Lisa Ricciardi, Cognition’s president and CEO .

Key Points: 
  • “The KOL roundtable we conducted featured a panel of Alzheimer’s disease expert clinicians and researchers who highlighted the need to find Alzheimer’s disease treatments that are less burdensome for patients and their care partners,” said Lisa Ricciardi, Cognition’s president and CEO .
  • The SHINE study enrolled participants in the U.S. and several countries in Europe including The Netherlands.
  • Dr. Vijverberg reviewed the design of the SHINE study and the results of the preliminary analysis of the first 24 patients who finished six months of treatment.
  • An archive of the KOL roundtable discussion is available on the News & Events page of the Investors section of the Cognition website or may be accessed directly at the following URL: https://lifescievents.com/event/cognition/ .

NKGen Biotech Announces Upcoming Presentation on SNK01 NK Cell Therapy in Neurodegenerative Disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit

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星期四, 四月 18, 2024
Amyloid, Neurodegenerative disease, Asian literature, MD, Patient, Biomarker, NK, Pharmaceutical industry

SANTA ANA, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y.

Key Points: 
  • SANTA ANA, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y.
  • Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details around its NK cell therapy in neurodegenerative disease, review its preclinical data in Parkinson’s disease, and highlight clinical safety and efficacy data from the Company’s recently completed Phase 1 clinical trial of SNK01, autologous natural killer cell therapy, in Alzheimer’s disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit to be held in Boston, MA, from April 23–25, 2024.
  • Dr. Song will also present clinical safety and efficacy data from the Company’s recently completed Phase 1 clinical trial evaluating autologous SNK01 NK cell therapy in patients with Alzheimer’s disease (NCT04678453).
  • A copy of the presentation will be available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/ once the presentation has concluded.

Alzheon Announces First Patient Dosed in Long-Term Extension of APOLLOE4 Phase 3 Trial of Oral ALZ-801/Valiltramiprosate and Launches 52-Week Extension of Phase 2 Biomarker Trial in Patients with Early Alzheimer’s Disease

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星期二, 四月 30, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Amyloid, MCI, APOE4, Risk, Safety, Cognition, MD, Doctor of Philosophy, ADAS, Disease, MB, Week, Atrophy, Patient, Master of Science, Alzheimer's disease, CSF, Genotype, Biomarker, Neurotoxicity, Cerebrospinal fluid, Plasma, Pharmaceutical industry

Early AD includes patients with mild cognitive impairment due to AD (MCI) and mild AD.

Key Points: 
  • Early AD includes patients with mild cognitive impairment due to AD (MCI) and mild AD.
  • ALZ-801/valiltramiprosate is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of Early AD.
  • In mechanism of action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.
  • “Given these encouraging results, we are compelled to extend the trial for an additional year, bringing the treatment period to four years for these patients.

Prothena Announces Review on Birtamimab Mechanism of Action and Pharmacological Characteristics Published in Leukemia & Lymphoma

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星期一, 四月 15, 2024
Research, Other Health, Pharmaceutical, Oncology, Other Communications, Publishing, Clinical Trials, Science, Cardiology, Biotechnology, Communications, FDA, Health, Amyloid, Mortality, Risk, Amyloidosis, Survival, Therapy, Bone marrow, Dysfunction, Patient, Failure, VITAL, Pharmaceutical industry

The publication can be found in the latest issue of Leukemia & Lymphoma, an international peer-reviewed journal that publishes research on all aspects of hematological malignancies.

Key Points: 
  • The publication can be found in the latest issue of Leukemia & Lymphoma, an international peer-reviewed journal that publishes research on all aspects of hematological malignancies.
  • Birtamimab binds to a highly conserved cryptic epitope which is only exposed in misfolded kappa and lambda light chain (LC) protein.
  • Birtamimab binds and neutralizes soluble, toxic LC aggregates and binds and clears insoluble AL amyloid deposits, without affecting normally folded LC proteins.
  • This mechanism of action is complementary to the current standard of care therapy for AL amyloidosis which does not target the existing toxic LC aggregates and amyloid deposits.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

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星期五, 四月 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference

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星期一, 三月 25, 2024
Plasma, Conference, Tau, Cell, Disease, CSF, Patient, Biomarker, Research, Median, Asian literature, ADAS-Cog, Tau protein, Safety, NK, Amyloid, Pharmaceutical industry

SANTA ANA, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C.

Key Points: 
  • The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers.
  • Cognitive assessments and CSF/plasma pTau217 and pTau181 analyses were performed at baseline and at 1 and 12 weeks after the final dose.
  • “The data presented today demonstrate additional beneficial effects of SNK01 for the treatment of Alzheimer’s disease,” commented Paul Y.
  • While the results were positive, the Phase 1 trial was a dose-escalation trial that only administered four total doses over 11 weeks.

Arctic Therapeutics and Nacuity Pharmaceuticals Announce European Medicines Agency Approval to Initiate First Clinical Trial of AT-001 (NPI-001) for the Treatment of HCCAA

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星期二, 三月 12, 2024
Retinitis pigmentosa, Disease, Partnership, Tablet, SVP, Stroke, Deficit spending, EMA, Cystinosis, GMP, European Medicines Agency, Clinical trial, Intraparenchymal hemorrhage, NACA, Safety, CSO, Cataract, Usher syndrome, Dementia, Oxidative stress, Amyloid, Service provider, Pharmaceutical industry

Current treatment options are severely limited, focusing primarily on symptom management rather than addressing the underlying cause of the disease.

Key Points: 
  • Current treatment options are severely limited, focusing primarily on symptom management rather than addressing the underlying cause of the disease.
  • “EMA's approval paves the way for a comprehensive investigation into the safety and efficacy of a novel therapeutic approach designed to halt or reverse the progression of HCCAA.
  • Nacuity is also currently evaluating NPI-001 in Phase 1/2 clinical trials in Australia for retinitis pigmentosa associated with Usher syndrome and cystinosis.
  • “Our proprietary NPI-001 has potential to address the myriad diseases and conditions where oxidative stress plays a role.

AltPep Study Published in Nature Journal, Scientific Reports, Further Affirms Potential of Blood Test to Detect Alzheimer's Disease

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星期五, 四月 5, 2024
Research, Neurology, Publishing, Communications, Clinical Trials, Biotechnology, Managed Care, Health, Science, Plasma, Scientific Reports, Patient, University, Amyloid, Neuropathology, MCI, Pharmaceutical industry

The data, consistent with an earlier study , further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD.

Key Points: 
  • The data, consistent with an earlier study , further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD.
  • The SOBA-AD blood test targets toxic soluble oligomers, an early molecular trigger of amyloid diseases, with the ultimate goal of identifying patients with the disease years before symptoms manifest.
  • The SOBA-AD blood test identified AD patients from cognitively unimpaired (CU) subjects with 100% sensitivity, >95% specificity, and >98% area under the curve (95% CI 0.95-1.00).
  • These results for our simple SOBA-AD blood test support the goal of earlier, pre-symptomatic detection of patients with AD.