Wallerian degeneration

Neuraptive Therapeutics Inc. Receives Orphan Drug Designation for its Lead Development Asset

Retrieved on: 
Monday, January 15, 2024
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Patient, Therapy, Nerve, Orphan, Orphan drug, Axon, EVP, Food, Food and Drug Administration, Wallerian degeneration, Physician, Pharmaceutical industry

Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit.

Key Points: 
  • Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit.
  • Dr. Seth Schulman, Chief Medical Officer of Neuraptive Therapeutics Inc., stated, “Receiving the Orphan Drug Designation for NTX-001 is a testament to our commitment to advancing healthcare solutions for patients impacted by peripheral nerve injuries who today have limited options.” The Orphan Drug Designation is granted to drugs intended to treat rare diseases or conditions in the US.
  • Highlights of Orphan Designation are:
    Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.
  • “ Following this designation, Neuraptive Therapeutics plans to accelerate the development of NTX-001, aiming to bring this promising treatment to patients as soon as possible.” Said Mr. Tzanis.

Neuraptive Therapeutics, Inc. Announces Achievement of Proof of Concept in The NEUROFUSE Study of NTX-001 for the Adjunct Treatment of Transected Peripheral Nerves

Retrieved on: 
Monday, January 8, 2024
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Quality of life, Science, Axon, Multimedia, Physician, Regeneration, Pain, Hope, Participation, Nerve, MHQ, Therapy, SAE, Randomness, Wallerian degeneration, Control, Standard of care, Nerve injury, Clinical trial, PGIC, Patient, Safety, SOC, EVP

Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.

Key Points: 
  • Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.
  • Key highlights from the NEUROFUSE Study:
    The NEUROFUSE Study is a 48-week, Multicenter, Randomized, Controlled, Evaluator-Blinded Study comparing NTX-001 as an adjunct treatment to standard of care vs. standard of care alone.
  • The study was to enroll 60 patients, and patients were randomized in a 1:1 ratio between treatments.
  • For more information about Neuraptive Therapeutics, Inc., and our pioneering work in peripheral nerve injury treatments, please visit Neuraptive.com.

INmune Bio, Inc. Announces Design of Upcoming Phase 2 Alzheimer’s Disease Clinical Trial and New Phase 1b AD Biomarker Data

Retrieved on: 
Monday, July 26, 2021
Branches of biology, Biology, Neuroscience, Biomarkers, Psychiatric diagnosis, Neurology, Myelin, Axon, Alzheimer's disease, Neuroinflammation, Wallerian degeneration

Boca Raton, FL, July 26, 2021 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the, “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced the design of its upcoming Phase 2 clinical trial of XProTM in patients diagnosed with mild Alzheimer’s disease (AD). The announcement is accompanied by the release of additional biomarker data from the Phase 1b AD trial that shows improvement in white matter (myelinated axons) that degenerate in AD patients.  

Key Points: 
  • The announcement is accompanied by the release of additional biomarker data from the Phase 1b AD trial that shows improvement in white matter (myelinated axons) that degenerate in AD patients.
  • "This is the first time in my career that I have seen positive changes, and in such a short time frame.
  • "Apparent fiber density decreases with axonal degeneration, and this is always seen in Alzheimer's disease patients.
  • In the Phase 1b study, we demonstrated XProTM significantly decreased biomarkers of neuroinflammation in Alzheimers patients.