AMYDIS, INC.


Associated tags: SAN, Medical imaging, Patient, CNS, Eye, Retina, Diagnosis, Biomarker, Pharmaceutical industry, Neurodegeneration, Research, Knowledge, Disease, Therapy, Trial of the century, Safety, Amyotrophic lateral sclerosis, ALS, NIH

Locations: LOS ANGELES, CA, US

Amydis Receives $3.4 million NIH Commercialization Readiness Pilot Grant Award to Map Heterogeneity of Alzheimer’s Diseases in Human Clinical Trial Using Novel Retinal Tracer

Retrieved on: 
Tuesday, November 14, 2023
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The grant will fund the use of novel fluorescent tracers to develop a comprehensive retinal biomarker database that maps the heterogeneity of Alzheimer’s pathogenesis.

Key Points: 
  • The grant will fund the use of novel fluorescent tracers to develop a comprehensive retinal biomarker database that maps the heterogeneity of Alzheimer’s pathogenesis.
  • Amydis is developing a platform of proprietary small molecule tracers that bind to misfolded protein deposits, including amyloid beta, alpha-synuclein and TDP-43.
  • “Our tracer enables the creation of a first-in-class multi-modal retinal image database that includes biomarkers in central nervous system tissue that characterize Alzheimer’s disease.
  • The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Amydis Launches Phase 2 Glaucoma Clinical Program Using Novel Retinal Tracer to Detect Amyloid Beta

Retrieved on: 
Thursday, November 2, 2023
University of California, San Diego Performance-Based Skills Assessment, UC San Diego Health, Glaucoma, Therapy, UCSD, Health, Amyloid, Disease, Paratriathlon, University, Eye, Trigeminal ganglion, OCT, Distinguishing, Patient, Diagnosis, Prognosis, Retina, SAN, Medical imaging, Ophthalmology

Glaucoma is an age-related neurodegenerative disease associated with the loss of retinal ganglion cells and characteristic vision loss.

Key Points: 
  • Glaucoma is an age-related neurodegenerative disease associated with the loss of retinal ganglion cells and characteristic vision loss.
  • Converging data indicate that amyloid beta, best known for its association with Alzheimer’s disease, is a key factor in glaucoma pathogenesis.
  • In collaboration with the University of California-San Diego (UCSD), Amydis completed critical proof-of-concept studies demonstrating the Amydis tracers detect amyloid beta in post-mortem human eyes of glaucoma patients, but not healthy subjects.
  • This multi-modal data will include optical coherence tomography (OCT) and OCT Angiography (OCT-A), enabling Amydis to map retinal amyloid beta, retinal structure (OCT), and retinal vascular (OCT-A) signatures and monitor their relative changes to better understand the pathophysiology of glaucoma.

Amydis Announces Enrollment of Cerebral Amyloid Angiopathy Participants in Phase 1/2a Retinal Tracer Trial

Retrieved on: 
Tuesday, February 21, 2023
Brain, Physician, Artery, Bangladesh Technical Education Board, NIH, CT, Safety, Cerebral amyloid angiopathy, MRI, PET, Amyotrophic lateral sclerosis research, Patient, Clinical trial, Eye, Ageing, Retina, CAA, CNS, Risk, Stroke, Disease, SAN, Notifiable disease, Dementia, Central nervous system, Pharmacokinetics, Medical imaging

This trial (NCT05709314) is part of a larger “basket trial” that also includes a study (NCT05542576) evaluating Amydis ocular tracer technology in amyotrophic later sclerosis and Parkinson’s disease.

Key Points: 
  • This trial (NCT05709314) is part of a larger “basket trial” that also includes a study (NCT05542576) evaluating Amydis ocular tracer technology in amyotrophic later sclerosis and Parkinson’s disease.
  • Additional information regarding the clinical trial, may be found at https://probeclinicaltrial.com/home .
  • The Amydis test is positioned as a more affordable and accessible test available to physicians.
  • “We are thrilled to expand our basket trial to enroll patients with CAA,” said Dr. Stella Sarraf, Chief Executive Officer and Founder of Amydis.

Amydis Awarded Third Grant From The Michael J. Fox Foundation To Support First-In-Human Study of a Retinal Tracer for Parkinson’s Disease

Retrieved on: 
Thursday, October 27, 2022
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This grant will support the first-in-human study of a retinal tracer targeting alpha-synuclein (ASYN) in a Prospective Randomized Open, Blinded Endpoint (PROBE) clinical study which is currently enrolling participants.

Key Points: 
  • This grant will support the first-in-human study of a retinal tracer targeting alpha-synuclein (ASYN) in a Prospective Randomized Open, Blinded Endpoint (PROBE) clinical study which is currently enrolling participants.
  • Additional information regarding the Phase 1/2a trial (NCT05542576) may be found at Fox Trial Finder.
  • We are honored to receive this third grant award which marks a longstanding collaboration with The Michael J.
  • Fox Foundation, said Dr. Stella Sarraf, chief executive officer and founder of Amydis.

Amydis Announces Enrollment of First Participants in PROBE, a Phase 1/2a Trial Evaluating a Novel Retinal Tracer in People with Amyotrophic Lateral Sclerosis or Parkinson’s Disease

Retrieved on: 
Thursday, September 22, 2022
Safety, Retina, Therapy, PK, Biomarker, Data monitoring committee, Hospital, Knowledge, Company, Massachusetts General Hospital, Patient, Eye, TAR, Doctor of Philosophy, Diagnosis, Amyotrophic lateral sclerosis, Harvard Medical School, CNS, SAN, ALS, Research, Pharmacokinetics, GLOBE, PD, Disease, Pharmaceutical industry, Medical imaging, Neurology

The primary objective of the study is the assessment of safety of AMDX-2011P in the target patient populations.

Key Points: 
  • The primary objective of the study is the assessment of safety of AMDX-2011P in the target patient populations.
  • Other objectives include determining the PK profile and the ability of AMDX-2011P to detect disease biomarkers in the retina of participants.
  • Additional information regarding the Phase 1/2a trial may be found at https://probeclinicaltrial.com/home .
  • Amydis is developingnovel, patent-protected molecules- ocular tracers- that enable direct visualization of CNS disease-related molecular changes (biomarkers) in the eye.

Amydis Receives NIH Grant Award to Develop a Novel TDP-43 Retinal Tracer in Patients with ALS and FTD

Retrieved on: 
Thursday, August 18, 2022
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The grant supports the development of a novel small-molecule retinal tracer targeting the biomarker TAR DNA-binding protein 43 (TDP-43) in patients with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).

Key Points: 
  • The grant supports the development of a novel small-molecule retinal tracer targeting the biomarker TAR DNA-binding protein 43 (TDP-43) in patients with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).
  • ALS is a devastating neurodegenerative disease that can be challenging to diagnose due to clinical overlaps with other conditions.
  • Currently, no definitive diagnostic technology is available for ALS and FTD.
  • FTD and ALS overlap genetically, clinically and pathologically, with approximately half of FTD patients manifesting cytoplasmic TDP-43 aggregates similar to those seen in ALS.

Amydis Appoints Dr. Robert N. Weinreb as First Chair of Scientific Advisory Board

Retrieved on: 
Monday, April 4, 2022
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as the First Chair to the Scientific Advisory Board of the Company.

Key Points: 
  • as the First Chair to the Scientific Advisory Board of the Company.
  • Amydis is at the forefront of developing compounds that enable retinal imaging of molecular biomarkers associated with many diseases, saidDr.
  • Weinreb.
  • Dr. Weinrebis the Distinguished Professor and Chair of Ophthalmology at the University of California San Diego.

Amydis Announces Successful Completion of a Pre-IND Meeting with the FDA for the Development of a First-in-Class Retinal Tracer Targeting TDP43 for the Diagnosis of ALS

Retrieved on: 
Monday, December 6, 2021
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The FDA agreed with the overall design of the proposed Phase 1/2a first-in-human clinical study in ALS patients.

Key Points: 
  • The FDA agreed with the overall design of the proposed Phase 1/2a first-in-human clinical study in ALS patients.
  • The design of the planned study may allow for an early read-out on the potential ability of the retinal tracer to aid in the diagnosis and management of patients with ALS.
  • ALS is a neurodegenerative disease that leads to progressive paralysis and death, usually within 3-5 years of diagnosis.
  • Currently, there are no objective diagnostics to detect, quantify, and monitor the most defining biomarker protein associated with ALS, called TDP43.

Amydis Awarded $3 Million NIH Grant to Explore Novel Alpha Synuclein Retinal Tracer in Non-human Primate Models of Parkinson’s Disease and Multiple System Atrophy

Retrieved on: 
Monday, October 11, 2021
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The two-year award will explore the presence of alpha synuclein (ASYN) in the retina of non-human primate models of Parkinsons Disease (PD) and Multiple System Atrophy (MSA).

Key Points: 
  • The two-year award will explore the presence of alpha synuclein (ASYN) in the retina of non-human primate models of Parkinsons Disease (PD) and Multiple System Atrophy (MSA).
  • Fox Foundation, Amydis has previously shown that its proprietary retinal tracers can detect ASYN in PD mouse models.
  • This NIH grant will also fund Investigational New Drug Application (IND)-enabling studies to support an IND filing with the Food & Drug Administration (FDA).
  • The planned Phase 1/2a clinical study will test Amydiss small-molecule retinal tracer targeting the biomarker ASYN for the diagnosis of synucleinopathies.

Amydis Receives NIH Grant Award to Develop a Novel Tau Retinal Tracer for Alzheimer's Diseases and other Tauopathies

Retrieved on: 
Thursday, September 2, 2021
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The grant will support the development of a novel small-molecule retinal tracer targeting the biomarker tau for the detection and diagnosis of Alzheimers disease and other tauopathies.

Key Points: 
  • The grant will support the development of a novel small-molecule retinal tracer targeting the biomarker tau for the detection and diagnosis of Alzheimers disease and other tauopathies.
  • 4R tau isoforms are more abundant in frontotemporal dementia (FTD) and progressive supranuclear palsy (PSP), whereas 3R tau is predominant in Picks disease.
  • Dr. Stella Sarraf, CEO and Founder of Amydis, stated, "We are very grateful to the NIH for their support of our tau program.
  • Amydis is developingnovel, patent-protected drugs - retinal tracers- that enable direct visualization of CNS disease-related molecular changes (biomarkers) in the retina.