L-DOPA

BioVie’s Bezisterim Demonstrates Potential Improvements in Sleep/Fatigue and Restless Leg Symptoms for Parkinson’s Disease Patients

Retrieved on: 
onsdag, maj 22, 2024
Placebo-controlled study, Data, L-DOPA, Carbidopa/levodopa, International Association, Patar, Iran, XXIX, Part, MDS-UPDRS, Pharmaceutical industry

CARSON CITY, Nev., May 22, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced data from an oral presentation made yesterday at the XXIX World Congress on Parkinson’s Disease and Related Disorders hosted by the International Association of Parkinsonism and Related Disorders (IAPRD) and held May 19-22, 2024 in Lisbon, Portugal.

Key Points: 
  • The presentation Improvement of Motor and Non-Motor Symptoms with Bezisterim Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study was presented on May 21, 2024, and suggest improvements of bezisterim-treated patients with non-motor symptoms.
  • These full dataset findings complement previously reported topline dataset findings of improvement in motor symptoms in patients treated with bezisterim and demonstrate potential intrinsic, levodopa-enhancing activity of bezisterim that is consistent with data from animal models.
  • In patients younger than 70 years old (~50% of patients), the advantage for bezisterim-treated patients was -4.7 points.
  • More patients on bezisterim had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.

Omeros Corporation Reports First Quarter 2024 Financial Results

Retrieved on: 
onsdag, maj 15, 2024
Biotechnology, Pharmaceutical, Health, Neovascularization, CUD, L-DOPA, Investment, FDA, DRI, EHA, Cocaine, Nature, Paroxysmal nocturnal hemoglobinuria, Patent, Sale, URL, Physician, PDE7, PIN, AMD, Corporation, Clinical trial, Congress, Trial of the century, Safety, Parkinson's disease, LDH, Research, European Hematology Association, Glomerulopathy, DSM-IV codes, Behavior informatics, Pharmacology, PNH, Patient, Royal College of Pathologists, Tardive dyskinesia, Cancer, Eye, Manuscript, Injection, Abstract, BLA, LID, Pharmaceutical industry

Net loss from continuing operations was $43.9 million for the first quarter of 2024 compared to $39.7 million for the first quarter of 2023.

Key Points: 
  • Net loss from continuing operations was $43.9 million for the first quarter of 2024 compared to $39.7 million for the first quarter of 2023.
  • “Our substantial progress and milestone achievements during the first quarter position Omeros well for continued success throughout 2024,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.
  • Interest expense during the first quarter of 2024 was $8.2 million compared to $7.9 million during the prior year quarter.
  • Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities.

Cerevel Therapeutics Announces Positive Topline Results for Tavapadon in Phase 3 Adjunctive Trial for People Living with Parkinson’s Disease

Retrieved on: 
torsdag, april 18, 2024
Brain, L-DOPA, Therapy, Patient, Safety, Pharmaceutical industry

CAMBRIDGE, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults. The trial met its primary endpoint – patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs. 0.6 hours, p

Key Points: 
  • The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults.
  • A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm.
  • The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon.
  • Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of 2024.

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

Retrieved on: 
måndag, april 8, 2024
Karolinska University Hospital, EudraCT, PD, L-DOPA, Patient, IGX, Doctor of Philosophy, MD, TSX, Clinical trial, Pharmaceutical industry

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

Key Points: 
  • SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.
  • MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD.
  • The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm® or placebo twice daily for 18-months, followed by a 3-month washout period.
  • Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents.

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
måndag, april 1, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, PIN, PNH, Patient, Sale, CUD, Graft-versus-host disease, Investment, Clinical trial, Hemolysis, Calcineurin, Emory University, ASH, Risk, L-DOPA, Thumbay Hospital, Behavior informatics, Trial of the century, Myelodysplastic syndrome, Cancer, Safety, Transplant, LID, DRI, BLA, Corporation, Paroxysmal nocturnal hemoglobinuria, Tardive dyskinesia, Parkinson's disease, Publication, DSM-IV codes, Retirement, FDA, PDE7, LDH, Hematology, Mortality, Hematopoietic stem cell transplantation, Bone marrow failure, Abstract, Society, Pharmacology, Pharmaceutical industry

Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Withdrawn application: Ongentys, 12/03/2024

Retrieved on: 
onsdag, april 3, 2024
Dopamine, DDCI, Brain, Letter, Capsule, Myenteric plexus, L-DOPA, Patient, Movement disorder, European Medicines Agency, Clinical trial, Mouth, MDS, Delayed onset muscle soreness, Movement, COMT, MDS-UPDRS, Medicine, Pharmaceutical industry

Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due.

Key Points: 
  • Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due.
  • It contains the active substance opicapone and is available as capsules to be taken by mouth.
  • t
    The application was withdrawn after the European Medicines Agency had evaluated the information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

BioVie Announces Pipeline Update and Near-Term Clinical Priorities

Retrieved on: 
måndag, mars 11, 2024
L-DOPA, PD, Research, MDS-UPDRS, UPDRS, FDA, Partnership, Ageing, Dopaminergic, Ascites, Part, ADAS, Food, Cirrhosis, Conference, Biomarker, Acute kidney injury, Patient, AKI, Longevity, Pharmaceutical industry

CARSON CITY, Nev., March 11, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that its recently completed funding round provides opportunity to further the Company’s clinical priorities in Parkinson’s Disease (PD), Alzheimer’s Disease (AD), and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators. 

Key Points: 
  • The Company continues to explore longevity and aging in conjunction with external collaborators.
  • The trial targets enrolling 100-150 patients in a 6-month trial with the Part 3 (motor) score on the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as the primary endpoint.
  • Only one Phase 3 trial is potentially needed as BIV201 has already received Orphan and Fast Track designations.
  • BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete.

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheime

Retrieved on: 
fredag, mars 1, 2024
L-DOPA, MCP1, Chemokine, Alzheimer's disease, Phagocytosis, Political moderate, Principal, MDS-UPDRS, Cholesterol, Insulin, Inflammation, Part, ADAS, Plaque, Conference, Placebo-controlled study, Parkinson's disease, Diabetes, Carbidopa/levodopa, Pharmacokinetics, Digestion, Disease, DNA methylation, DNA, Brain, Pharmaceutical industry

CARSON CITY, Nev., March 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal.

Key Points: 
  • These findings complement previously reported improvement in motor symptoms in patients treated with NE3107 and demonstrate potential intrinsic, levodopa-enhancing activity of NE3107 that is consistent with data from animal models.
  • NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159).
  • Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259).
  • More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.

NEW PAPER: Parkinson's Patients Struggle to Access Optimal Treatment

Retrieved on: 
torsdag, februari 1, 2024
L-DOPA, Tremor, Policy, Parkinson's disease, Patient, Disease, Movement disorder, FDA

WASHINGTON, Feb. 1, 2024 /PRNewswire/ -- Coverage delays, restrictive insurance policies and a lack of specialized health care providers often prevent Americans with Parkinson's disease from receiving optimal treatment, explains a new physician-authored policy paper from the Movement Disorders Policy Coalition.

Key Points: 
  • Parkinson's Disease: Improving Treatment While Working Toward a Cure ," describes the highly individualized nature of the disease and the importance of having accessible options to tailor treatment.
  • For example, newer formulations of the first line Parkinson's treatment levodopa can prolong patients' relief from symptoms and are available in multiple forms – oral, inhaled or infused – to accommodate patients' individual needs.
  • Health plan restrictions like step therapy can block patients from getting the medication that works best for them.
  • Long delays between when the FDA approves a new medication and when health plans begin covering the treatment can also undermine treatment.

AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson's Disease in the European Union

Retrieved on: 
tisdag, januari 9, 2024
Senior, Family, Development, Dyskinesia, Hyperkinesia, Patient, European, Dementia, MD, Uncertainty, ABBV, Cellulitis, University, Parkinson's disease, PD, Disability, Aes, Tremor, Hypertonia, University of Padua, Movement, Safety, L-DOPA, Doctor of Philosophy, Neurology, AbbVie, Edema, Hallucination, Hypokinesia, Pharmaceutical industry

NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results.1

Key Points: 
  • The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA received Conformité Européenne (CE) Mark in November of 2023.
  • Parkinson's disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally3 and is expected to double by 2040.
  • "This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson's disease, their families, and care partners."
  • "It is vital that the Parkinson's community have more options that can help them manage their symptoms."