UPDRS

BioVie Announces Pipeline Update and Near-Term Clinical Priorities

Retrieved on: 
Monday, March 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.

Pharma Two B Announces Publication of Positive Phase 3 Study Results of P2B001, an Investigational Treatment for Early Parkinson’s Disease, in Movement Disorders

Retrieved on: 
Thursday, November 9, 2023
UPDRS, Incidence, PD, III, Neurology, University of South Florida, Physician, Emeritus, Pramipexole, Epworth Sleepiness Scale, FRCPC, LSM, ESS, Somnolence, University, Department of Neurology, Xuanwu hospital, Mount Sinai School, NDA, Safety, Patient, PPX, Movement disorder, Dietary supplement, Pharmaceutical industry, Surveying

The study included 544 untreated patients with Parkinson’s disease who were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole-ER 0.6 mg or rasagiline-ER 0.75 mg), or marketed PramiER individually titrated to optimal dose (1.5-4.5 mg).

Key Points: 
  • The study included 544 untreated patients with Parkinson’s disease who were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole-ER 0.6 mg or rasagiline-ER 0.75 mg), or marketed PramiER individually titrated to optimal dose (1.5-4.5 mg).
  • Further, he stated that “P2B001 is a once-a-day treatment that requires no titration.
  • P2B001 was generally well tolerated and showed fewer sleep-related and dopaminergic adverse events in comparison to commercially used doses of pramipexole ER.
  • “We look forward to moving P2B001 forward towards an NDA submission to make this potential treatment option available to patients.”

Novel Application of Machine Learning Approaches Predicts Gait Dysfunction in Parkinson's Disease

Retrieved on: 
Sunday, August 27, 2023
Average absolute deviation, Rectifier (neural networks), Magnetic resonance imaging, DTI, Disease, MLP, Perceptron, Recursive neural network, Department of Neurology, Xuanwu hospital, Movement disorder, Movement, DWI, Parkinson's disease, Patient, HIV disease progression rates, Machine learning, AUC, Neurology, UPDRS, International Congress on Tuberculosis, Medical imaging, PD

COPENHAGEN, Denmark, Aug. 27, 2023 /PRNewswire-PRWeb/ -- A machine learning approach from diffusion tensor imaging (DTI) multi-spectral diffusion weighted imaging (DWI) showed prediction of gait dysfunction in PD according to a study released today at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.

Key Points: 
  • COPENHAGEN, Denmark, Aug. 27, 2023 /PRNewswire-PRWeb/ -- A machine learning approach from diffusion tensor imaging (DTI) multi-spectral diffusion weighted imaging (DWI) showed prediction of gait dysfunction in PD according to a study released today at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.
  • Several neuroimaging studies in Parkinson's disease (PD) suggest an altered interplay between cortical and subcortical brain areas at a structural and functional level each that contributes to gait dysfunction in PD.
  • This study used 7 different quantitative DTI measures from 43 PD patients along with UPDRS III, to develop a prediction model for gait dysfunction using different machine learning approaches and 60 template regions of interest (ROIs).
  • "This study suggests that a machine learning approach of DTI analysis may have potential in predicting gait dysfunction in PD patients if confirmed by larger confirmative studies.

Three months of probiotic therapy shown to reduce motor and nonmotor Parkinson's disease symptoms

Retrieved on: 
Sunday, August 27, 2023
Tremor, University, PD, Probiotic, Disease, Constipation, Research, Attention, Assistant, Movement, Parkinson's disease, Patient, Frustration, UPDRS, Bacteria, MPH, International Congress on Tuberculosis, Pharmaceutical industry, MD

COPENHAGEN, Denmark, Aug. 27, 2023 /PRNewswire-PRWeb/ -- Probiotics may be a viable therapeutic avenue for PD patients suffering from prolonged 'off' periods, constipation and sleep deficits, according to a multicenter randomized controlled trial released today at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.

Key Points: 
  • After 12 weeks of probiotic therapy, shallow shotgun sequencing revealed an increased occurrence of beneficial flora, while UPDRS scores demonstrated a significant reduction in motor (i.e., 'time to on') and nonmotor (i.e., gastrointestinal, sleep/fatigue) symptoms.
  • Probiotic therapy is rooted in the idea that the intentional introduction of 'good' bacteria could help regulate metabolites that may be intrinsically linked to disease processes.
  • stands out as a significant contribution to this area of study, aiming to understand the impact of a four-strain probiotic on gut dysbiosis, motor symptoms and non-motor symptoms in PD patients with constipation.
  • The authors' conclusion highlights that the four-strain probiotic effectively enhances gut microbiota, improves 'time to on' and alleviates the burden of non-motor symptoms among PD patients with constipation.

Healthcare Veteran, Zach Henderson to lead Global Kinetics as CEO

Retrieved on: 
Wednesday, May 3, 2023
Disease, DSM-IV codes, Huntington's disease, Research, MD, Patient, Algorithm, Parkinson's disease, United Kingdom, Growth, Dyskinesia, PKG, Movement disorder, NHS, NICE, Caregiver, Kinetics, National Institute for Health and Care Excellence, Management, Pharmaceutical industry, Chorea, Hypokinesia, UPDRS

Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.

Key Points: 
  • Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.
  • Zach recently served as the Chief Commercial Officer of Glooko, where he led the rapid growth of the business with life science partners and healthcare providers.
  • "With the largest body of published clinical evidence and over 35,000 patients treated, Global Kinetics has the deepest clinical data set in the neurology field," said Zach Henderson, newly appointed CEO of Global Kinetics.
  • Mr. Henderson's appointment as CEO follows several exciting announcements for Global Kinetics.

Healthcare Veteran, Zach Henderson to lead Global Kinetics as CEO

Retrieved on: 
Wednesday, May 3, 2023
Disease, DSM-IV codes, Huntington's disease, Research, MD, Patient, Algorithm, Parkinson's disease, United Kingdom, Growth, Dyskinesia, PKG, Movement disorder, NHS, NICE, Caregiver, Kinetics, National Institute for Health and Care Excellence, Management, Pharmaceutical industry, Chorea, Hypokinesia, UPDRS

Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.

Key Points: 
  • Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.
  • Zach recently served as the Chief Commercial Officer of Glooko, where he led the rapid growth of the business with life science partners and healthcare providers.
  • "With the largest body of published clinical evidence and over 35,000 patients treated, Global Kinetics has the deepest clinical data set in the neurology field," said Zach Henderson, newly appointed CEO of Global Kinetics.
  • Mr. Henderson's appointment as CEO follows several exciting announcements for Global Kinetics.

Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, February 7, 2023
Annual general meeting, Genetics, Essential tremor, UPDRS, Safety, CNS, Central nervous system disease, Pharmacokinetics, Epilepsy, Therapy, Dees, OFF, UCB, Central nervous system, American Epilepsy Society, Patient, PK, KCNT1, FDA, Investment, AES, Tremor, Pharmaceutical industry, Praxis

BOSTON, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update and reported financial results for the fourth quarter and full year 2022.

Key Points: 
  • The primary endpoint is change from baseline to day 56 in the modified Activities of Daily Living (mADL1) score.
  • Following topline results, Praxis intends to request an end-of-Phase 2 meeting with the FDA and initiate its ulixacaltamide Phase 3 development program for the treatment of ET in mid-2023.
  • Topline results from the Phase 1 study are expected in mid-2023, with plans to initiate a Phase 2 study in focal epilepsy in the fourth quarter of 2023.
  • In December 2022, Praxis presented the following posters at the American Epilepsy Society (AES) 2022 Annual Meeting:

Pharma Two B Presents Positive Efficacy and Safety Data of P2B001 from Phase 3 Trial at the MDS International Congress of Parkinson's Disease and Movement Disorders®

Retrieved on: 
Thursday, September 15, 2022
Tablet, ADL, Safety, Icahn School of Medicine at Mount Sinai, Mount Sinai, FDA, Food, MDS, Rasagiline, Patient, Dopamine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Movement disorders, CEO, Hallucination, ESS, Calibration, Movement, Somnolence, Orthostatic hypotension, Neuroscience, Ageing, GLOBE, PD, Pharma, Neurology, Parkinson's disease, Congress, Disease, Pharmaceutical industry, Pramipexole, Epworth Sleepiness Scale, UPDRS

today announced that positive efficacy and safety data from its recently completed randomized, controlled Phase 3 trial of investigational P2B001 in the management of early PD will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders Sept. 15-18 in Madrid.

Key Points: 
  • today announced that positive efficacy and safety data from its recently completed randomized, controlled Phase 3 trial of investigational P2B001 in the management of early PD will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders Sept. 15-18 in Madrid.
  • The data will be presented in various formats, including a guided poster tour, an e-poster and video on the MDS Congress virtual platform, and publication in the Movement Disorders journal supplement.
  • We are pleased that the positive data from our Phase 3 study of P2B001 in early Parkinsons patients were selected for presentation at the MDS International Congress, said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B.
  • P2B001 has the potential to be an important first line treatment option for patients with early Parkinsons disease.

Pharma Two B Presents Late-Breaker Abstract on Positive Efficacy and Safety Data of P2B001 from Phase 3 Trial at American Academy of Neurology (AAN) Annual Meeting

Retrieved on: 
Tuesday, April 5, 2022
Neuroscience, Orthostatic hypotension, ESS, Therapy, Dopamine, Somnolence, American Academy of Neurology, ER, CEO, Hallucination, Excessive daytime sleepiness, Safety, Mount Sinai, Icahn School of Medicine at Mount Sinai, Randomized controlled trial, GLOBE, American Academy, AAN, Epworth Sleepiness Scale, Baddi University of Emerging Sciences and Technologies, Patient, Pharmaceutical industry, Neurology, Pramipexole, UPDRS

As such, if approved, P2B001 may offer a therapy with improved benefit risk ratio between efficacy and safety for Parkinsons disease patients.

Key Points: 
  • As such, if approved, P2B001 may offer a therapy with improved benefit risk ratio between efficacy and safety for Parkinsons disease patients.
  • Of note, the low doses utilized in P2B001 are not currently available on the market and the ER rasagiline is a proprietary dosage form.
  • Pharma Two B recently reported that P2B001 met its primary and key secondary endpoints in a Phase 3 pivotal study.
  • Pharma Two B has completed a Phase 3 trial with P2B001 and is preparing to file an NDA later this year.

Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson’s Disease

Retrieved on: 
Wednesday, December 15, 2021
Mount Sinai, Epworth Sleepiness Scale, FDA, Orthostatic hypotension, Neuroscience, Excessive daytime sleepiness, Calibration, UPDRS, M.B.A, III, Environment, Unified Parkinson's disease rating scale, Icahn School of Medicine at Mount Sinai, Pramipexole, Neurological disorder, Life expectancy, Capsule, Safety, University, Patient, Disease, ER, Neurology, PD, ESS, Hallucination, Part, Pharmaceutical industry

REHOVOT, Israel, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, today announced that its Phase III double-blind, active-controlled study of P2B001 in early Parkinson’s disease (PD) successfully met its primary and key secondary endpoints.

Key Points: 
  • The results demonstrated both superior efficacy to components and a more favorable safety profile than treatment with standard doses of pramipexole.
  • With increased life expectancy and longer disease duration, patients will often require dopaminergic replacement therapies for many years.
  • If approved, this product will be an important new option when considering a long-term care plan for people with early-stage Parkinsons disease.
  • The companys lead product P2B001 is being investigated as a treatment for early-stage Parkinsons disease.