EP-104IAR has been designed for meeting the market demand for long-lasting disease relief in many indications and gain benefit from highly localised and longer delivery of corticosteroids.
It encapsulates a highly potent corticosteroid (fluticasone propionate) in a microns-thin polymer membrane, which is part of the company’s patented technology platform.
After injected into the knee, EP-104IAR diffuses the drug slowly into the knee joint and provides therapeutic concentrations for up to six months.
It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company.
Eupraxia Pharmaceuticals CEO Dr James Helliwell said: “Being granted Fast Track designation for EP-104IAR is another important step for our clinical development programme.
“OA affects millions of people in the United States and most of these people have limited options to manage their symptoms.”
The company is advancing its ongoing Phase II trial, which has been designed for evaluating the efficacy and safety of EP-104IAR as a treatment candidate for knee OA.
It expects to obtain top-line data from the trial in the second quarter of this year.
According to the U.S. Centers for Disease Control and Prevention, more than 30 million people are estimated to have knee OA in the country.