pegylated form of exenatide for diabetes (NLY01-D) / D&D Pharmatech - LARVOL DELTA

[VIRTUAL] The GLP-1R Agonist NLY01 Reduces Neuroinflammation and Protects Against RGC Loss in a Preclinical Glaucoma Model (AGS 2021) - No abstract available

Preclinical • Glaucoma • Immunology • Inflammation • Ophthalmology

[VIRTUAL] The Antiinflammatory and Neuroprotective Effects of NLY01, A Novel Glucagonlike Peptide1 Receptor Agonist, in Experimental Autoimmune Encephalomyelitis (ACTRIMS Forum 2021) - "Our results demonstrate the anti-inflammatory and neuroprotective properties of NLY01 in EAE and its therapeutic potential for neurodegeneration. The cellular mechanisms underlying the therapeutic effect of the drug on glial cells are currently under investigation."

CNS Disorders • Gastrointestinal Disorder • Immunology • Movement Disorders • Multiple Sclerosis • Parkinson's Disease • CD44 • CXCL1 • GFAP • ITGAM • TNFA

A Study With NLY01 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2a; N=20; Completed; Sponsor: Neuraly, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Neuraly, Inc.; Trial primary completion date: Jul 2022 ➔ Oct 2022

Clinical • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

[Bio] Leading the way in developing Parkinson's disease treatment... Overcoming degenerative brain disease is not far [Google translation] (Maekyung Media Group) - "NLY01 is conducting global clinical trials through Neurally,...'In the case of Parkinson's disease, there are a total of 240 patients for phase 2 clinical trials, and the first patient administration will be started in February and will be completed in the second half of 2022. I will apply for conditional authorization with the FDA.'"

Trial status • CNS Disorders • Parkinson's Disease

A Study With NLY01 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2a; N=24; Active, not recruiting; Sponsor: Neuraly, Inc.; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Neuraly, Inc.; Trial completion date: Apr 2021 ➔ Aug 2022; Trial primary completion date: Mar 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Neuraly Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 2B Trial of NLY01 for Patients with Alzheimer’s Disease (Businesswire) - "Neuraly, Inc....today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease....The Phase 2B Alzheimer’s study is a multicenter, randomized, double-blinded, placebo-controlled trial that is expected to enroll more than 500 patients at more than 100 sites in the US, Canada and Europe. The study is designed to assess the safety, tolerability and efficacy of NLY01 in subjects with mild cognitive impairment due to Alzheimer’s disease. Topline results are expected by Q4, 2023; Concurrent Phase 2 Clinical Trial is Evaluating NLY01 for Parkinson’s Disease."

Enrollment status • IND • P2b data • Trial status • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

GLP-1 Receptor Agonist NLY01 Reduces Retinal Inflammation and Neuron Death Secondary to Ocular Hypertension. (PubMed, Cell Rep) - "Ablation of this pathway, by either genetic deletions of C1qa, IL-1α, and TNF-α, or treatment with glucagon-like peptide-1 receptor agonist NLY01, reduces A1 astrocyte transformation and RGC death. Together, these results highlight a neuroinflammatory mechanism of glaucomatous neurodegeneration that can be therapeutically targeted by NLY01 administration."

Journal • CNS Disorders • Glaucoma • Hypertension • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • ITGAM

D&D Pharmatech applies for IND for Alzheimer's disease treatment to FDA [Google translation] (Dementia News) - "D&D Pharmatech announced on the 12th that it has completed an application for the phase 1 clinical IND for Alzheimer's disease phase 2b IND for degenerative brain disease treatment NLY01...In particular, in the case of NLY01, if the US IND approval for Alzheimer's disease clinical phase 2b is received this time, it becomes a global phase 2 clinical trial case of simultaneous development of Parkinson's disease and Alzheimer's disease as a single item....On the 1st of this month, an additional phase 2b clinical IND for 518 patients with mild cognitive impairment due to Alzheimer's disease was submitted to the FDA."

IND • New P1 trial • New P2b trial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

D&P Pharmatech, Parkinson’s disease, Alzheimer’s clinical trial phase 2 [Google translation] (ET news) - "New drug development Bioventure D&D Pharmatech is conducting phase 2 clinical trials for new drug candidates for degenerative brain disease and fibrosis treatment in the second half of the year....'We started clinical trials for Parkinson's disease in phase 2 with 240 patients in February this year, and we plan to proceed with phase 2 clinical trials for Alzheimer's dementia in the second half to 300.....It is expected that the first phase of clinical trials for Parkinson's disease...results in the first half of 2022. The second phase of Alzheimer's dementia will also begin in the second half of 2020."

Enrollment status • New P2 trial • P2 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

A Study With NLY01 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2a; N=24; Active, not recruiting; Sponsor: Neuraly, Inc.; Trial completion date: Mar 2020 ➔ Sep 2020; Trial primary completion date: Mar 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date

The A1 astrocyte paradigm: New avenues for pharmacological intervention in neurodegeneration. (PubMed, Mov Disord) - "We recently demonstrated that NLY01, a novel glucagon-like peptide-1 receptor agonist, exerts neuroprotective effects in two mouse models of PD in a glia-dependent manner...Finally, we discuss implications for the overall goal of creating disease-modifying therapies for PD, survey emerging methodologies for accelerating translational research on glia in neurodegeneration, and describe expected challenges for developing glia-directed therapies that do not impede essential physiological functions carried out by glia in the CNS."

Journal

Correcting and Replacing Neuraly announces first patient dosed in phase 2 clinical trial of NLY01 for patients with Parkinson’s disease (Businesswire) - "Neuraly...today announced the dosing of the first patient in its Phase 2 clinical trial of NLY01 for Parkinson’s disease....The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial that is expected to enroll approximately 240 patients in the US and Canada. The study is designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early Parkinson's disease....Topline results are expected within 24 months."

Trial status

Therapeutic Potential of a Novel Glucagon-like Peptide-1 Receptor Agonist, NLY01, in Experimental Autoimmune Encephalomyelitis (ACTRIMS Forum 2020) - "Our results demonstrate the potential therapeutic effect of GLP-1 receptor agonists in EAE. The cellular mechanisms underlying the therapeutic effect of the drug on glial cells are currently under investigation."

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Neuraly, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study With NLY01 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2a; N=24; Active, not recruiting; Sponsor: Neuraly, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Newly added product (clinicaltrials.gov) - P2, Parkinson's Disease

Pipeline update