Myelin

SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Retrieved on: 
Wednesday, March 13, 2024
Medical Devices, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Vagus nerve, Neurology, Brain, Rheumatoid arthritis, Communication, Multiple sclerosis, Patient, Myelin, Remyelination, Neck, Axon, Clinical trial, Johns Hopkins University, Pain, Nerve, Fatigue, Set, FDA, Visual impairment, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • Breakthrough Device Designation will enable interactive communication and priority regulatory review with the FDA, and support reimbursement and patient access upon FDA approval of SetPoint’s technology.
  • This Breakthrough Device Designation is based on evidence demonstrating that SetPoint's treatment has the potential to reduce demyelination and promote remyelination.
  • In 2020, the FDA also granted Breakthrough Device Designation to SetPoint's device for the treatment of rheumatoid arthritis (RA).

Cadenza Bio, Inc. Appoints Michael A. Panzara, MD, MPH, to its Board of Directors

Retrieved on: 
Thursday, April 4, 2024
Neurology, Sanofi, Alemtuzumab, Myelin, Public health, Growth, Massachusetts General Hospital, Multiple sclerosis, University, Patient, Research, Inflammation, Biology, Interferon beta-1a, MPH, Brigham and Women's Hospital, DSM-IV codes, Hospital, Drug development, Natalizumab, Rheumatology, Pharmaceutical industry

He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company.

Key Points: 
  • He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company.
  • "We are delighted to welcome Dr. Panzara to our board of directors," said Dr. Carol Curtis, chief executive officer of Cadenza Bio.
  • "His extensive experience in developing therapies for MS and other neurological disorders aligns perfectly with our mission at Cadenza Bio.
  • "I look forward to joining the board of directors at Cadenza Bio at such an exciting time in the growth of the company," said Dr. Panzara.

Anokion Announces Clinical Progress with KAN-101 and ANK-700

Retrieved on: 
Tuesday, September 12, 2023
Health, Neurology, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Demyelinating disease, Myelin, Safety, Spinal cord, Clinical trial, SAD, Brain, Multiple sclerosis, CNS, MS, Incidence, RRMS, Patient, Autoimmune disease, Immune tolerance, Immune system, Assessment, MAD, Liver, Coeliac disease, Neuroinflammation, Vaccine, Pharmaceutical industry

Anokion SA , a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today reported progress for its clinical-stage programs, KAN-101 and ANK-700.

Key Points: 
  • Anokion SA , a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today reported progress for its clinical-stage programs, KAN-101 and ANK-700.
  • Anokion has designed ANK-700 to re-educate the immune system by inducing antigen-specific tolerance to myelin-based autoantigens to reduce neuroinflammation in the brain and spinal cord.
  • The study will continue with a 12-month safety follow-up expected to complete in the first half of 2024.
  • Anokion anticipates reporting full results from its MoveS-it clinical trial in the second half of 2024.

Globally Recognized Expert in Rare Neurologic Diseases, Dr. Michael Levy, Joins Trethera Scientific Advisory Board

Retrieved on: 
Tuesday, September 5, 2023
Demyelinating disease, DSM-IV codes, Optic neuritis, Central nervous system, University, Johns Hopkins Hospital, Myelin, Spinal cord, Cancer, Coronavirus Scientific Advisory Board, American Academy, Brain, Inflammation, Multiple sclerosis, Doctor of Philosophy, Associate, MS, Harvard Medical School, Nerve, CNS demyelinating autoimmune diseases, Patient, Division, Optic nerve, ADEM, Baylor College of Medicine, Hospital, Massachusetts General Hospital, American Academy of Neurology, Acute disseminated encephalomyelitis, Peripheral nervous system, Pharmaceutical industry, Philosophy, MD, Neurology

Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.

Key Points: 
  • Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.
  • When the myelin sheath is damaged, nerve impulses slow or even stop, causing neurological problems.
  • “We are honored to have Dr. Levy join our advisory board,” said Dr. Ken Schultz, Chairman and CEO of Trethera.
  • “He is a leading authority on rare neurologic autoimmune diseases and has expertise in both early and late-stage clinical trials.

Frequency Therapeutics Provides Business Updates and First Quarter 2023 Financial Results

Retrieved on: 
Friday, May 12, 2023
Health, General Health, Cognition, NCE, Rat, Cognitive deficit, Myelin, Therapy, Grey, Clinical trial, MD–MS program, Research, Biomarker, Multiple sclerosis, Remyelination, VEP, Trial of the century, MS, Regenerative medicine, Development, MRI, State Administrative Expenses, Magnetic resonance imaging, HIV disease progression rates, Patient, Administration, Frequency, Mouse, White matter, Visual acuity, Axon, Disease, Pharmaceutical industry, Medical imaging, Vaccine

Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced business updates and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced business updates and financial results for the first quarter ended March 31, 2023.
  • Cash Position: As of March 31, 2023, Frequency had cash, cash equivalents and marketable securities of $66.7 million (excluding restricted cash), or $55.0 million net of debt.
  • Excluding stock-based compensation expense of $0.8 million, research and development expenses for the three months ended March 31, 2023 were $10.6 million.
  • Excluding stock-based compensation expense of $2.6 million, general and administrative expenses for the three months ended March 31, 2023 were $6.6 million.

BrainTale Has Been Invited at the AD/PD Conference to Present the Interest of Its Digital Biomarkers Platform to Improve the Management of Alzheimer's Disease

Retrieved on: 
Thursday, April 6, 2023
Biotechnology, Technology, Health, Pharmaceutical, Neurology, Security, Research, Software, Genetics, Science, Clinical Trials, Communication, Disease, Myelin, Hospital, DSM-IV codes, Ageing, Brain, Biomarker, Incidence, MRI, Dementia, International Conference on Emerging Infectious Diseases, Patient, Myenteric plexus, White matter, Diagnosis, AD, Conference, Axon, Medical imaging, Alzheimer's disease

Vincent Perlbarg, co-founder, scientific director and president of BrainTale, presented data obtained in the early diagnosis of Alzheimer's disease supporting the interest of brainTale-care digital biomarker platform in patient management as well as in the development of new therapeutic approaches.

Key Points: 
  • Vincent Perlbarg, co-founder, scientific director and president of BrainTale, presented data obtained in the early diagnosis of Alzheimer's disease supporting the interest of brainTale-care digital biomarker platform in patient management as well as in the development of new therapeutic approaches.
  • Thus, BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools for patients suffering from brain diseases since its creation in 2018.
  • These preliminary data highlight the sensitivity of the white matter biomarkers developed by BrainTale to specific Alzheimer's disease, notably in early forms of the disease.
  • With the new version of the brainTale-care biomarker platform available since a few weeks, centers and partners equipped with BrainTale technology can now improve the management of these patients.

Frequency Therapeutics Provides Business Updates and Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Friday, March 10, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, SNHL, Therapy, Trial of the century, Axon, MRI, Biomarker, Frequency, State Administrative Expenses, Sensorineural hearing loss, MD–MS program, MS, Multiple sclerosis, Patient, Regenerative medicine, Speech perception, Clinical trial, Administration, VEP, Myelin, Development, Magnetic resonance imaging, Remyelination, Pharmaceutical industry, Medical imaging, Cryptocurrency

Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced business updates and financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced business updates and financial results for the fourth quarter and full year ended December 31, 2022.
  • MS in characterized by demyelination, stripping axons of the myelin sheaths that support neuronal signal conduction and axonal survival.
  • Net Loss: Net loss was $17.4 million for the three months ended December 31, 2022, as compared to $21.5 million for the comparable period of 2021.
  • Net loss was $81.6 million for the full year ended December 31, 2022, as compared to $84.7 million for the comparable period of 2021.

Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss

Retrieved on: 
Monday, February 13, 2023
Health, Clinical Trials, Biomarker, Regenerative medicine, Meningitis, Therapy, MRI, Safety, Sensorineural hearing loss, VEP, Hearing loss, Patient, CSO, Clinical trial, Frequency, Interim, Magnetic resonance imaging, Speech perception, Myelin, MS, Remyelination, SNHL, Pharmaceutical industry

The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception.

Key Points: 
  • The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception.
  • Prior FX-322 studies had been designed to best understand patient etiologies and severities where a hearing signal could be observed.
  • The safety profile associated with FX-322 was favorable and no study participants experienced a serious adverse event that was associated with treatment.
  • Given these disappointing results, we will cease further development of the Company's drug candidates for hearing loss.

BrainTale Has Presented the Interest If Its Digital Biomarkers Platform in Differential Diagnosis During the 15th Edition of Clinical Trials on Alzheimer’s Disease Conference

Retrieved on: 
Monday, December 5, 2022
Medical Devices, Health, Neurology, Other Health, Clinical Trials, Biotechnology, Hospital, Neurological disorder, Degenerative disease, Physician, Neurodegeneration, Clinical trial, Disease, Amyotrophic lateral sclerosis, Diagnosis, Diffusion, Dementia, Biomarker, Patient, ISO, Research, CSO, White matter, HIV disease progression rates, Neurology, Incidence, MDR, European Medical Writers Association, Axon, Ageing, Adaptive clinical trial, Brain, Myelin, Risk, Medical imaging, Pharmaceutical industry, Medical device, Alzheimer's disease

Alzheimers disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year.

Key Points: 
  • Alzheimers disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year.
  • Results show that BrainTale biomarkers are relevant biomarkers of disease severity, and that the platform has the potential for a differentiated diagnosis perspective.
  • Our data suggest a very exciting complementary approach to existing initiatives to better diagnose, and ultimately better treat Alzheimers disease patients.
  • With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, BrainTale offers a digital biomarkers platform to support clinical decision-making.

Frequency Therapeutics Provides Business Updates and Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 8, 2022
Biotechnology, Pharmaceutical, Health, Other Health, State Administrative Expenses, Breakthrough therapy, Sensorineural hearing loss, U.S. Securities and Exchange Commission, Webcast, MS, Scripps Research, Remyelination, Growth, FDA, Patient, SEC, Company, Legislation, Compliance, TFI, Private Securities Litigation Reform Act, Fast Track, Frequency, Massachusetts Eye and Ear, US Foods, Program, Noise, Administration, Multiple sclerosis, COVID-19, Bias, Myelin, Hearing loss, Health, Massachusetts Institute of Technology, Failure, Science, Ear, Mass General Brigham, Nasdaq, Secondary research, Speech perception, Regenerative medicine, Marketing, Research, SNHL, Cochlea, Development, Therapy, PCA, Safety, Intellectual property, Security (finance), Pharmaceutical industry, IND, Astellas Pharma

Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced business updates and financial results for the third quarter ended September 30, 2022.

Key Points: 
  • Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced business updates and financial results for the third quarter ended September 30, 2022.
  • FX-322-208 Phase 2b Study in Acquired Sensorineural Hearing Loss (SNHL): In October, Frequency announced enrollment completion for its FX-322-208 study.
  • FX-322-208 is a randomized, placebo-controlled, multi-center study designed to evaluate the efficacy of a single administration of FX-322 on speech perception.
  • Pre-clinical Program for Remyelination in Multiple Sclerosis (MS): Frequency is advancing to IND-enabling studies its program for remyelination in MS.