Colorado based Ampio Pharmaceuticals (NYSE:AMPE) has announced that osteoarthritis patients injected with its experimental anti-inflammatory drug Ampion had a significant reduction in knee pain in a late stage clinical trial. The company says the drug could someday be used to treat a wide variety of painful inflammatory diseases.
In the Phase III study of 329 osteoarthritis patients, participants were randomly selected to receive one of two doses (4mL or 10mL) of Ampion or a saline injection. Patients who received a single injection of Ampion had an average 40% reduction in knee pain, along with significant improvement in knee function and quality of life during the 12-week study, according to the company.
Ampio said there were no significant differences in the efficacy of the two Ampion doses. Selection of the optimal dose for a second Phase III trial will be decided in consultation with the Food and Drug Administration.
“This is fantastic,” said Brian McGrath, MD, principal investigator and an orthopedic surgeon at University Orthopedics Services in Amherst, New York. “These results highlight the strong possibility that it may soon be possible to offer patients an effective therapy.”
Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It is a progressive disorder of the joints, caused by inflammation of the soft tissue, which worsens over time and leads to thinning of cartilage.
“I was pleasantly surprised at the positive response rate in patients with otherwise intractable osteoarthritis of the knee. I am also hoping to study Ampion injections into the base of the thumb and base of the toe for which there is no current therapy,” ” said Nathan Wei, MD, a rheumatologist at the Arthritis Treatment Center in Frederick, Maryland.
Ampion is a new biologic drug being developed as a non-steroidal injection for the treatment of diseases involving inflammation. It is derived from a molecule (DA-DKP) that is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T-cells.
According to the company, Ampion has the potential to be used in a wide variety of acute and chronic inflammatory conditions, such as osteoarthritis, rheumatoid arthritis and autoimmune diseases.
“We are very pleased with the results of the trial. Both doses of Ampion provided osteoarthritis patients with pain relief,” said Michael Macaluso, chairman and CEO of Ampio.
“The broad inclusion criteria for the trial reflected a real world application of this biologic to a diverse patient population, making these results even more impressive. This should greatly encourage the enormous population of patients afflicted with OAK (osteoarthritis of the knee) and the physicians who treat them.”