Paradigm Biopharma focused on injectable pentosan polysulfate development. The most advanced clinical program is to investigate the use of a drug as a potential disease that modifies the treatment for knee osteoarthritis or kOA.
Knee Osteoarthritis treatment
Paradigm announced the evaluation of injectable pentosan polysulfate sodium as a potential knee osteoarthritis disease-modifying treatment. The highlights from the temporary data include:
- Structural modifications in some other diseases features measured by MRI (Magnetic Resonance Imaging)
- Probable support for DMOAD (Disease-Modifying OA Drug) activity from movements in the biomarker data
- Continuous positive reactions in WOMAC scores
- Paradigm plans on discussing with the EMA and FDA a potential regulatory pathway for DMOAD movement labeling.
Knee Osteoarthritis is a highly prevalent disease lacking disease-modifying treatments and provides a significant opportunity for the Paradigm. The company has various active clinical programs.
Therapies to meet unmet demand
The paradigm biopharmaceuticals perform an advanced clinical program investigating injectable PPS for disease-modifying treatment for kOA, a global prevalent condition with unmet medical needs. Many sufferers of the condition find difficulty in looking for the right medicine. But, there is no guaranteed medicine or treatment proven for the knee condition. With a paradigm, they have studied how to meet the unmet demand for kOA.
The modifying treatment for knee osteoarthritis continually targets many people suffering from this painful condition. The company has investigated the use of iPPS for rare genetic diseases and mucopolysaccharidosis types:
- MPS type I
- MPS type VI
The company has been investigating the use of iPPS continually as it has been supported by capital raises, which the management expects, it provides a runway, and additional cash needed to fund the final part of the steps of the program.
Ample clinical data for the development
The paradigm’s development program for the treatment of knee osteoarthritis is supported by data from various studies. The most recent demonstrated a clinically relevant change in the synovial joint biomakers associated with:
- Inflammation
- Cartilage degradation
- Pain
- Patient-reported pain
- Function score
The program is encouraging support for the iPPS’s utility. But, safety data and long-term efficacy from Phase III are essential in fully establishing the impact of the drug. If you are suffering or one of your loved ones from knee osteoarthritis, you might be suggesting this drug temporarily. Sooner or later, you will find out that this drug can’t just be a temporary kind of drug for kOA, but instead a continuous or good maintenance of your long-time knee pain.
Disease modification
In the review, the key to maximizing commercial success is the demonstration of the disease-modifying profile in knee osteoarthritis, which is believed the main design of the clinical program. When you can’t observe any disease modification, iPPS still form an essential part of osteoarthritis treatment regimens, it is a symptomatic treatment for stiffness and pain.
Altogether, the management estimates the opportunity for the iPPS in hip or knee osteoarthritis.
