Knee pain afflicts many people specially those who are suffering from osteoarthritis, are overweight or are not physically fit, especially with age. Unfortunately there is usually no long term medication and usually doctors simply prescribe pain killers, stronger ones when over the counter remedies don’t work. Often diseases like osteoarthritis are progressive in any case and so the pain only gets worse.
Ampio Pharmaceuticals, a publicly listed company, has announced that new trial reveals that its experimental drug, Ampion, helped in reducing knee pain. According to its press release, 27 million people in the U.S. suffer from arthritis.
What is Ampion and how does it work?
The drug is a biologic, a new molecular entity (NME) and has to be taken by injection. It is a non-steroid pain-killer and comes from a molecule DA-DKP. It works by reducing inflammation in the T cells by suppressing the effects of cytokine production that causes inflammation in the first place. The drug was discovered by Dr. David Bar-Or and is derived from the Human Serum Albumin (HAS) that has been used for over 40 years for various disorders, including severe anemia, cirrhosis of the liver, ARDS (adult respiratory distress syndrome) and even dehydration and burns.
Biologic drugs are thought to be safer because they are derived from natural substances already present in the body. So they have fewer side effects and may prove more effective.
A phase III study followed 329 people divided into three groups, randomly given either 4 ml or 10 ml of Ampion or a placebo by intra-articular injection. Only a single injection was given during the course of the 12 week study.
According to the results, patients who received Ampion achieved a 40 percent reduction in pain when compared with the control group. One of the aims of the research to see which dose would be optimum to reduce pain, but the study did not show significant differences in the two groups that received 4 ml or 10 ml of the drug. Patients also showed improved function and greater improvement in the quality of life. What is even more important is that effects started four weeks after the injection and continued for up to 12 weeks. There were no drug related adverse events that were serious.
The dosage for the second Phase III trial will be decided upon after consultation with the Food and Drug Administration.
Uses for other diseases
If all goes well, Ampion has the potential to treat many other inflammatory disorders including rheumatoid arthritis, acute and chronic inflammatory conditions and auto-immune diseases.
Further research will also include giving the injection at the base of the thumb or the base of the toe, making it even more convenient to use.