Tag - Neuraly

Neuraly Announces Topline Results from Phase 2 Trial of NLY01 in Parkinson’s Disease

Antonette Ho2023-04-01T23:46:27-04:00Neuraly, a clinical-stage biotechnology company pioneering development of disease-modifying agents for neurodegenerative disorders, today announced topline results from the Phase 2 trial with NLY01 in patients with early, untreated Parkinson’s disease (PD). The primary endpoint, change from baseline to Week 36 in the sum of MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Examination) after 36 weeks of NLY01 treatment, compared to placebo, did not reach statistical significance. NLY01 was safe and well tolerated. The effect was...

Neuraly Announces Completion of Enrollment in Phase 2 Clinical Trial of NLY01 in Patients with Parkinson’s Disease

Ziad2022-11-25T13:59:57-05:00Neuraly, a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced the completion of patient enrollment in its Phase 2 study of NLY01 for Parkinson’s disease (PD). NLY01, Neuraly’s lead development asset, is a glucagon-like peptide 1 receptor (GLP-1R) agonist that has been demonstrated to inhibit pathological activation of microglia by binding upregulated GLP-1R in animal models of neurodegenerative diseases such as PD. Read more >>

FDA Clears Neuraly to Begin Phase 2 Trial of NLY01 in Alzheimer’s Patients

Ziad2022-11-25T14:02:05-05:00 The U.S. Food and Drug Administration has given clearance for a Phase 2B clinical trial to evaluate the safety, tolerability, and efficacy of Neuraly's investigational therapy NLY01 in people with Alzheimer's disease. The randomized, double-blinded, placebo-controlled trial is expected to enroll more than 500 people with mild cognitive impairment due to Alzheimer’s disease at more than 100 sites in the U.S., Canada, and Europe. Read more >>

Neuraly Announces Strategic Sponsored Research Agreement with the University of Pennsylvania to Explore use of NLY01 to Therapeutically Target a Neuroinflammatory Mechanism of Glaucoma

Ziad2022-11-25T14:02:05-05:00 Neuraly, Inc, a clinical-stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced a strategic sponsored research agreement with the University of Pennsylvania to study the use of NLY01 to therapeutically target a neuroinflammatory mechanism of glaucoma. Read more >>

Neuraly Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 2B Trial of NLY01 for Patients with Alzheimer’s Disease

Ziad2022-11-25T14:02:05-05:00 Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, 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. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020. Read more >>

First Patient Dosed in Neuraly’s NLY01 Trial Testing Safety, Efficacy

Ziad2022-11-25T14:02:39-05:00 The first patient has been dosed in a Phase 2 study testing NLY01, an investigational compound with a new mechanism of action designed to stall the progression of Parkinson’s disease. NLY01, being developed by Neuraly, could prevent nerve cell loss in the brain by stopping the toxic activation of immune cells. Read more >>

CORRECTING and REPLACING Neuraly Announces First Patient Dosed in Phase 2 Clinical Trial of NLY01 for Patients with Parkinson’s Disease

Ziad2022-11-25T14:02:39-05:00 All mentions of NLY01 have been corrected -- Neuraly, a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced the dosing of the first patient in its Phase 2 clinical trial of NLY01 for Parkinson’s disease. Read more >>

D&D bags $137M to fund midphase Alzheimer’s, Parkinson’s trials

Ziad2022-11-25T14:03:27-05:00 Working out of sites in Korea and the U.S., D&D serves as the parent company for three spinouts from Johns Hopkins School of Medicine. The highest profile of the three subsidiaries is Neuraly, which raised a $36 million series A round last year to take long-acting glucagon-like peptide-1 receptor agonist NLY01 into the clinic.Read more >>

Johns Hopkins spinout Neuraly launches with $36M funding round

Ziad2022-11-25T14:04:54-05:00The Maryland biotech startup is developing new treatments for Parkinson's disease and Alzheimer’s disease. Read more >>

Startup Neuraly Raises $36M to Bring Potential Disease-Modifying Treatments to Patients with Parkinson’s Disease

Ziad2022-11-25T14:04:54-05:00Today, Neuraly announced its launch to pioneer the development of disease-modifying agents for neurodegenerative disorders. Read more >>