Ampion in the treatment of knee osteoarthritis stage III clinical success

Source: Sina Pharmaceutical News 2017-12-18 ampio Pharma is a biopharmaceutical company focused on developing innovative therapies for the treatment of inflammatory diseases with very limited selection Recently, the company announced that the experimental anti-inflammatory drug ampion in the treatment of severe knee osteoarthritis (oak) reached the primary and secondary end points in the critical phase III clinical research Ampion is a non steroidal anti-inflammatory biological agent, which has the potential to treat a wide range of acute and chronic inflammatory diseases and immune diseases At present, ampion is being developed as an intra-articular injection drug for the treatment of oak Based on the phase III clinical data, ampio is preparing to submit its biological product license application (BLA) to the US FDA If approved, ampion will be the first intra-articular drug to treat severe oak (kl4) symptoms and signs, which will fill a significant treatment gap in this field The phase III study published this time is a multicenter, randomized study, which was carried out in 144 patients with kl4 grade oak (KL grading standard is 5 grades, respectively 0, 1, 2, 3, 4, kl4 is the most serious condition) In the study, patients were randomly given a single 4 ml intra-articular injection of ampion or placebo in a 6:1 ratio The primary end point of the study was the proportion of responders based on rheumatic clinical trials and the international society for the study of osteoarthritis (omerarct-oarsi) at the 12th week after a single injection Data showed that up to 71% of patients in the ampion group met the omeact-oarsi responder standard at the 12th week after injection, which exceeded the clinically significant threshold of 30% reported by clinicians (P < 0.001) Omeact-oarsi used single variable to evaluate the three core symptoms of oak: pain, body function and patients' quality of life Specifically, in the ampion treatment group, the pain of the responders was reduced by 53% (measured by WOMAC a), the function was improved by 50% (measured by WOMAC C), and the quality of life was improved by 45% (measured by PGA) In terms of secondary end point, at the 12th week after injection, the ampion treatment group also achieved a statistically significant improvement (P < 0.001) in pain and body function composite end point relative to the baseline, which was supported by the improvement in quality of life based on PGA evaluation (P < 0.001) Summary data from several clinical studies conducted showed that compared with all kl4 saline injection groups (n = 206), the ampion treatment group (n = 144) achieved a statistically significant improvement in pain and function composite endpoints (P < 0.001) In this study, ampion was well tolerated and adverse events (teaes) during treatment were comparable to those in the placebo group To date, more than 900 patients have been treated with ampion and no serious drug-related teae has been reported Ampion's safety and tolerability were consistent with previous studies Ampion will release more detailed analysis and summary data of the phase III clinical study at a future medical conference According to Michael Macaluso, chairman and CEO of ampio, these data show that ampion will provide a very important non opioid treatment option for the severe oak population, which can not only reduce pain, but also improve the body function and quality of life The drug will be expected to solve the significant unmet medical needs in the field of severe oak Ampion is a low molecular weight fragment of human serum albumin (HSA) Its main component is aspartyl propionyldiketone piperazine (da-dkp), which is an endogenous immunoregulatory molecule from the N-terminal of HSA According to the published preclinical and clinical studies, da-dkp plays an important role in the regulation of inflammatory response Da-dkp is believed to reduce inflammation by inhibiting the production of proinflammatory cytokines in T cells In addition to da-dkp, there are other small molecules in ampion that have been proved to have anti-inflammatory effect, which can supplement the effect of da-dkp Osteoarthritis (OA) is a kind of incurable and progressive joint disease, involving the degeneration of articular cartilage, joint lining, ligament and bone It is the most common arthritis, which will cause joint pain, limited activity and significantly reduce the quality of life of patients It is estimated that the total number of OA patients in the world is more than 200 million OAK is the most common OA in the limbs, which incidence rate is about 45% in human life This disease is especially harmful to the health of the elderly The incidence of OAK with clinical symptoms in elderly people over 60 years old is significantly higher OAK is related to age, obesity and diabetes With the aging of the population and the increase of the obese population, the incidence rate of OAK is expected to increase gradually At present, the clinical standard treatment of OA is mainly to use non steroidal anti-inflammatory and analgesic drugs to relieve symptoms Although these drugs may be very effective, they can cause serious side effects, such as gastrointestinal bleeding, liver and kidney problems and hypertension Opioids can also be used in patients without remission treated with other drugs, but there is also a risk of addiction and death Non opioid and non steroidal anti-inflammatory drugs such as ampion are expected to provide a safer and more tolerable treatment option.