Phase III clinical success of Ampion in the treatment of knee osteoarthritis
December 18, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Ampio Pharma is a biopharmaceutical company focused on developing innovative therapies for the treatment of very limited inflammatory diseases. Recently, the company announced that the experimental anti-inflammatory drug Ampion for severe knee osteoarthritis (OAK) reached the primary and secondary endpoints in a critical phase III clinical study. Ampion is a non-steroidal anti-inflammatory biologic that has the potential to treat a wide range of acute and chronic inflammatory diseases as well as immune diseases and is currently being developed as an intra-articular injection for the treatment of OAK. Based on this phase III clinical data, Ampio is preparing to submit Ampion's Biological Product Licensing Application (BLA) to the US FDA. If approved, Ampion will be the first intra-articular injection to treat severe OAK (KL4) symptoms and signs, which will fill a significant treatment gap in the field.
The phase III study was a multicenter, randomized study of 144 patients with KL4 OAK (KL grading criteria were 5, 0, 1, 2, 3, 4, respectively. serious). In the study, patients were randomized to receive a single 4 mL intra-articular injection of Ampion or placebo in a 6:1 ratio. The primary endpoint of the study was the proportion of respondents assessed at the 12th week after a single injection based on the Rheumatology Clinical Trial and Osteoarthritis International Research Society Standard (OMERACT-OARSI).
The data showed that up to 71% of patients in the Ampion treatment group met the OMERACT-OARSI responder criteria at 12 weeks post-injection, a figure that exceeded the 30% clinically significant threshold reported by clinicians in the treatment of severe OAK ( p < 0.001). OMERACT-OARSI uses a single variable to assess the three core symptoms of OAK: pain, body function, and patient quality of life. Specifically, responders in the Ampion treatment group had an average reduction in pain of 53% (using WOMAC A), a 50% improvement in function (using WOMAC C), and a 45% improvement in quality of life (using PGA [patient evaluation]).
At the secondary endpoint, at the 12th week after the injection, the Ampion treatment group also achieved a statistically significant improvement in the composite endpoint of pain and body function relative to baseline (p < 0.001), which improved life based on PGA assessment. Support for quality improvement (p<0.001). A summary of data from several clinical studies conducted showed that the Ampion-treated group (n=144) achieved statistically significant at the pain and functional composite endpoint compared with all KL4-level saline-injected groups (n=206). Improvement (p < 0.001).
In this study, Ampion was well tolerated and adverse events (TEAEs) during treatment were comparable to placebo. To date, more than 900 patients have been treated with Ampion and no drug-related severe TEAE has been reported. Ampion's safety and tolerability are consistent with previous studies. Ampion will present a more detailed analysis and summary of this Phase III clinical study at a future medical conference.
Ampio Chairman and CEO Michael Macaluso said the data suggests that Ampion will provide a very important non-opioid treatment option for the severe OAK population, not only to reduce pain, but also to improve body function and quality of life. The drug is expected to address the significant unmet medical needs of the severe OAK field.
Ampion is a low molecular weight fragment of human serum albumin (HSA) whose main component is aspartyl-alanyl diketopiperazine (DA-DKP, a cyclic di-amino acid), which is a kind An endogenous immunomodulatory molecule derived from the amino terminus (N-terminus) of HSA. According to published preclinical and clinical studies, DA-DKP plays an important role in regulating inflammatory responses. DA-DKP is thought to reduce inflammation by inhibiting the production of pro-inflammatory cytokines in T cells. In addition to DA-DKP, Ampion contains other small molecules that have been shown to have anti-inflammatory effects, complementing the effects of DA-DKP.
Osteoarthritis (OA) is an incurable, progressive joint disease involving the degradation of articular cartilage, joint lining, ligaments and bones. It is one of the most common types of arthritis, causing joint pain and limited mobility. The quality of life of patients is significantly reduced. It is estimated that the total number of OA patients worldwide exceeds 200 million. OAK is the most common OA in the joints of the extremities. The incidence rate in human life is about 45%. The disease is especially harmful to the health of the elderly. The incidence of clinically symptomatic OAK in the elderly over 60 years old is significantly increased. OAK is associated with age, obesity, and diabetes. As the social population ages and the obese population increases, the incidence of OAK is expected to increase gradually.
At present, the standard clinical treatment of OA is mainly the use of non-steroidal anti-inflammatory analgesics 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 high blood pressure. Opioids can also be used in other medications without remission, but there is also a risk of addiction and death. Non-opioid, non-steroidal anti-inflammatory drugs such as Ampion are expected to provide a safer, more tolerable treatment option. (Sina Pharmaceutical Compilation/newborn)
Article reference source: Ampio boosted by Phase 3 success in osteoarthritis
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