• Paradigm Biopharma’s Phase 2 meets primary endpoint
  • TrivarX collaborates with US university to advance sleep research

 

Paradigm’s successful Phase 2 trial

Paradigm Biopharma (ASX:PAR) announced that its Phase 2 clinical trial, PARA_MPSVI_001, has successfully met its primary endpoint.

The trial was designed to evaluate the use of Paradigm’s injectable pentosan polysulfate sodium (iPPS) compared to placebo in 13 participants with Mucopolysarcharidosis Type VI (MPS VI).

Results indicated that iPPS was well-tolerated in those patients, who were 5 years old and over, when iPPS was given once weekly over 24 weeks.

All 13 MPS VI participants reported improvements in PROMIS and VAS pain assessments – well known assessments for pain intensity – from baseline following 24 weeks of iPPS treatment.

In addition, patients showed improved CHAQ Disability Index Score, a patient-completed questionnaire which gives a subjective score of level of function (disability) in activities of daily living, following iPPS treatment.

Currently, there are options out there to treat MPS VI, a progressive condition that causes many tissues and organs to enlarge, become inflamed or scarred, and eventually waste away.

Treatments available for MPS VI include disease-modifying enzyme replacement therapy (ERT) and supportive medical and surgical interventions. All patients participatig in this Phase 2 study were on ERT for over one year.

Despite these available therapies, there remains an unmet need for MPS VI patients treated with enzyme replacement therapy, who continue to experience musculoskeletal pain and symptoms that reduce their quality of life.

Paradigm says iPPS presents the first drug therapy targeted specifically at complications associated with MPS including pain and arthropathy for MPS VI patients.

 

TrivarX to advance sleep research in US

Meanwhile, TrivarX (ASX:TRI) has entered into a data transfer agreement with the Department of Psychological Sciences at Northern Michigan University (NMU).

Under the agreement, NMU and TrivarX will collaborate on sleep research programs where NMU will share sleep research data with the company, and TrivarX will provide NMU with specific metrics that Stager extracts from sleep data.

TrivarX’s Stager is an AI-based software solution that provides rapid data metrics on the four key stages of sleep. It’s intended to be used by researchers in fields including behavioral sleep medicine.

The collaboration with NMU follows extensive discussions between the parties to pursue research aimed at using novel and neurophysiological monitoring approaches for evaluating stress and other mental health conditions.

TRI says NMU has selected TrivarX as a research partner due to the company’s experience with mental health conditions, and understanding of how sleep may play a critical role in the diagnosis of them.

TRI believes the collaboration has the potential to unlock breakthroughs relating to the role of brain activity during sleep, and the level and type of mental illness, potentially including predictors of the onset of mental disorders.

NMU meanwhile is located in Marquette, Michigan, and has grown a reputation for its award-winning programs, cutting-edge technology initiatives, and nationally recognised academic programs.

 

 

 

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