Neurofilament

Alterity Therapeutics Parkinson’s Disease and Multiple System Atrophy Data Featured at the American Academy of Neurology (AAN) 2024 Annual Meeting

Retrieved on: 
onsdag, april 17, 2024
Molecule, Neuroimaging, American Academy, Brain, Iron, Oxidative stress, MSA, AFL, Poster, Disease, Vanderbilt University, Substantia nigra, Plasma, ASX, Pathology, Neurofilament, Forecasting, Macaque, Nerve, Multiple system atrophy, Patient, Treatment, Observational study, AAN, CSF, Neuron, Biomarker, Annual general meeting, Vanderbilt University Medical Center, Therapy, Cerebrospinal fluid, Parkinsonism, ATH, Frasier, SAN, Medical imaging

MELBOURNE, Australia and SAN FRANCISCO, April 17, 2024 (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 three posters were presented at the American Academy of Neurology (AAN) 2024 Annual Meeting taking place April 13-18, 2024, in Denver, Colorado, USA. Featured presentations described the Company’s work in Parkinson’s disease and Multiple System Atrophy (MSA), including initial biomarker data and baseline characteristics from the ATH434-201 Phase 2 clinical trial.

Key Points: 
  • Featured presentations described the Company’s work in Parkinson’s disease and Multiple System Atrophy (MSA), including initial biomarker data and baseline characteristics from the ATH434-201 Phase 2 clinical trial.
  • At AAN we reported the baseline characteristics from our ATH434-201 Phase 2 trial including fluid biomarkers and neuroimaging data.
  • The data showed increased iron in areas of pathology and elevated plasma Neurofilament Light Chain (NfL) levels at baseline that correlated significantly with disease severity.
  • Plasma NfL significantly increased over 12 months, and both plasma and CSF NfL were associated with disease progression in MSA.

Gain Therapeutics’ GT-02287 Completely Restores Motor Function in Mouse Models of Parkinson’s Disease

Retrieved on: 
tisdag, februari 6, 2024
Neuroprotection, Poster, Pharmacokinetics, ALS, AFL, Clinical trial, Patient, Safety, Mutation, FDA, Animal, Food, MPS II, Disease, Therapy, MPS, Neurofilament, SOD1, Glucocerebrosidase, GBA1, Plasma, Pharmaceutical industry

The data was accepted as a late-breaker abstract and will be presented at the 20th Annual WORLDSymposium™ being held in San Diego this week.

Key Points: 
  • The data was accepted as a late-breaker abstract and will be presented at the 20th Annual WORLDSymposium™ being held in San Diego this week.
  • “We believe the data showing complete restoration of motor function in a therapeutic model are remarkable and further support the potential of GT-02287 to slow or stop the progression of Parkinson’s disease, a disease for which only symptomatic treatments are available to patients at this time,” said Matthias Alder, Gain Therapeutics’ Chief Executive Officer.
  • Further, animals in the most challenging treatment group – those that began treatment eight days following onset of the disease – showed motor improvement from day 14 to day 27, which suggests progressive reversal of neuronal deficit associated with continued treatment duration.
  • Further details of the study, including protocol and specific results can be found in the poster, which was presented today and can be accessed here .

Clene Provides Update on ALS Clinical Development Meeting With FDA

Retrieved on: 
torsdag, december 21, 2023
Food, ALS, Survival, FDA, Multiple sclerosis, CNM, Neurofilament, AFL, Bangladesh Technical Education Board, Patient, Pharmaceutical industry

Clene met with the FDA to discuss CNM-Au8® for the treatment of ALS, presenting initial clinical and Neurofilament Light Chain (NfL) biomarker results from the completed Phase 2 ALS studies.

Key Points: 
  • Clene met with the FDA to discuss CNM-Au8® for the treatment of ALS, presenting initial clinical and Neurofilament Light Chain (NfL) biomarker results from the completed Phase 2 ALS studies.
  • Clene is looking forward to providing supplemental data for further engagement with the FDA in the first half of 2024, including additional long-term clinical evidence and biomarker results of CNM-Au8’s treatment benefit in people living with ALS.
  • “We are also encouraged that the recently disclosed long-term NfL biomarker decreases are consistent with delayed clinical time-to-event outcomes.”
    Rob Etherington, CEO of Clene, said, “Clene is committed to people living with ALS.
  • Importantly, we also plan to submit new information to the FDA for further discussions on the totality of evidence in order to advance the accelerated development of CNM-Au8 for the treatment of ALS.”

uniQure Announces Update on Phase I/II Clinical Trials of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease

Retrieved on: 
tisdag, december 19, 2023
CSF, Patient, Nosebleed, Cure, Risk, Șaeș, Interest, Pulmonary embolism, PIN, Depression, FRCP, Headache, TMS, CHDI, Brain, Neurofilament, SAE, Clinical trial, TFC, Natural history, Event, Inflammation, Hypothermia, AFL, University College London, Biomarker, Back pain, Suicidal ideation, Central nervous system, Frasier, Deep vein thrombosis, UCL, Pharmaceutical industry

The U.S. study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of five years for treated patients.

Key Points: 
  • The U.S. study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of five years for treated patients.
  • Six patients were treated with AMT-130 in the initial low-dose cohort and seven patients were treated in the subsequent high-dose cohort.
  • The cohort includes 31 patients that met the uniQure clinical trial inclusion criteria of Total Functional Capacity, Diagnostic Classification Level and minimum striatal volumes.
  • In mid-2024, uniQure expects to present another clinical update from the ongoing Phase I/II studies of AMT-130, including additional follow-up data from the treated patients in the U.S. and European trials.

BioVie Announces Efficacy Data from Phase 3 Trial of NE3107 in Patients with Mild to Moderate Alzheimer’s Disease

Retrieved on: 
onsdag, november 29, 2023
Patient, DNA methylation, MITT, GFAP, Food, Activator (genetics), Glial fibrillary acidic protein, FDA, Disease, Biostatistics, DNA, OSI, GCP, Neurofilament, Natural history, Good clinical practice, Horváth, COVID-19, Dementia, Ageing, Biomarker, Pathology, Safety, Therapy, Significance, Pharmaceutical industry

CARSON CITY, Nev., Nov. 29, 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 positive analysis of unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate Alzheimer’s Disease (AD).

Key Points: 
  • Data from evaluable patients show NE3107’s treatment advantage compared to placebo may be equal to or greater than the benefit from approved AD monoclonal antibodies.
  • NE3107-treated patients also experienced a 4.66-year advantage in age deceleration vs. placebo as measured by epigenetics/DNA methylation Skin Blood Clock.
  • The trial started during the COVID-19 pandemic when access to clinical sites was limited and enrolled a total of 439 patients through 39 sites.
  • Patients treated with NE3107 saw an average of -5.66 years of age deceleration of the DNA methylation advantage compared to those on placebo.

New Results From HEALEY ALS Platform Trial Show Promise for Treating ALS

Retrieved on: 
tisdag, oktober 17, 2023
Diagnosis, Congress, ALS, Nerve, Food, Spinal cord, Biology, Brain, MD, Food and Drug Administration Amendments Act of 2007, Massachusetts General Hospital, Hospital, Disease, FDA, Growth, Gene, Harvard Medical School, Neurofilament, Amyotrophy, Blood, WCN, Research, Quality of life, Pharmaceutical industry, Medical imaging, Neurology

Recently, based on results of the HEALEY ALS Platform Trial , two experimental medications plan to move to phase 3 clinical trials.

Key Points: 
  • Recently, based on results of the HEALEY ALS Platform Trial , two experimental medications plan to move to phase 3 clinical trials.
  • There are currently five approved drugs on the market for ALS as opposed to one 10 years ago, and the HEALEY ALS Platform Trial is accelerating the search for more treatments by enabling researchers to test multiple drugs simultaneously.
  • The HEALEY ALS Platform Trial is a first-of-its-kind effort to test multiple experimental treatments simultaneously and on a rolling basis.
  • The HEALEY ALS Platform Trial began in 2020 and has since completed 5 rounds of clinical trials with two upcoming trials actively recruiting participants.

EQS-News: Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Retrieved on: 
tisdag, oktober 17, 2023
Calcium, Neuroprotection, MS, Inflammation, Multiple sclerosis, Safety, Neurofilament, Magnetic resonance imaging, Biotechnology, Barrow Neurological Institute, Clinical research coordinator, RRMS, Research, Emphasis, MRI, AFL, PMS, Patient, Cleveland Clinic, Frankincense, Pharmaceutical industry, Short course immune induction therapy

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Key Points: 
  • Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting
    The issuer is solely responsible for the content of this announcement.
  • Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting
    – NfL Effect Consistent With Recently Released Data from Separate, Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis –
    NEW YORK, October 11, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced that Robert J.
  • EMPhASIS was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • On October 9, 2023, Immunic announced positive interim data from its phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis (PMS).

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Retrieved on: 
onsdag, oktober 11, 2023
Calcium, Neuroprotection, MS, Inflammation, Multiple sclerosis, Safety, Neurofilament, Magnetic resonance imaging, Barrow Neurological Institute, Clinical research coordinator, RRMS, Research, Emphasis, MRI, AFL, PMS, Observation, Patient, Cleveland Clinic, Pharmaceutical industry, Short course immune induction therapy

NEW YORK, Oct. 11, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, today presented data from the company's phase 2 EMPhASIS trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place October 11-13 in Milan, Italy.

Key Points: 
  • Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, today presented data from the company's phase 2 EMPhASIS trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place October 11-13 in Milan, Italy.
  • Dr. Fox has served as Coordinating Investigator in Immunic's multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.
  • EMPhASIS was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • On October 9, 2023, Immunic announced positive interim data from its phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis (PMS).

EQS-News: Immunic to Participate in Scientific Conferences in October

Retrieved on: 
onsdag, oktober 4, 2023
Abstract, Cleveland Clinic, Short course immune induction therapy, Metabolism, IBD, United European Gastroenterology, Biotechnology, UEG, Regeneration, Multiple sclerosis, Doctor of Philosophy, Netherlands, MS, Hepatology, MD, Gastroenterology, Neurofilament, Human, Regulatory affairs, Montreal Neurological Institute and Hospital, Research, Coeliac disease, Treatment, Pharmaceutical industry, Pharmacovigilance

NEW YORK, October 4, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific conferences in October:

Key Points: 
  • NEW YORK, October 4, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific conferences in October:
    October 11-13: MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting.
  • The poster presentation will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations .
  • Title: Reduction in Neurofilament Light Chain by Vidofludimus Calcium: The EMPhASIS Study
    October 14-17: UEG (United European Gastroenterology) Week 2023.
  • Darius-Jean Namdjou, PhD, Head of Regulatory Affairs and Pharmacovigilance at Immunic, will speak during two sessions at this summit in Brussels, Belgium.

Immunic to Participate in Scientific Conferences in October

Retrieved on: 
onsdag, oktober 4, 2023
Abstract, Cleveland Clinic, Metabolism, IBD, United European Gastroenterology, Biotechnology, UEG, Regeneration, Multiple sclerosis, Doctor of Philosophy, Netherlands, MS, Hepatology, MD, Gastroenterology, Neurofilament, Human, Regulatory affairs, Montreal Neurological Institute and Hospital, Research, Coeliac disease, Treatment, Vaccine, Pharmacovigilance, Short course immune induction therapy

The poster presentation will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations .

Key Points: 
  • The poster presentation will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations .
  • Title: Reduction in Neurofilament Light Chain by Vidofludimus Calcium: The EMPhASIS Study
    October 14-17: UEG (United European Gastroenterology) Week 2023.
  • The presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations .
  • Darius-Jean Namdjou, PhD, Head of Regulatory Affairs and Pharmacovigilance at Immunic, will speak during two sessions at this summit in Brussels, Belgium.