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On September 15, 2021, Ampio Pharmaceuticals announced that the investigational therapy Ampion has achieved positive top-line results in the phase 3 clinical trial AP-013
.
The trial evaluated the efficacy of intra-articular (IA) injection of Ampion in adults with severe knee osteoarthritis (OAK)
.
According to a recent research article published in The Lancet, it is estimated that about 650 million people worldwide suffer from OAK, which is a progressive inflammation characterized by elevated cytokines and is difficult to cure
.
In addition to the simple quality of life problem, the mortality rate of patients with osteoarthritis is significantly higher than that of the general population
.
Ampion is a new type of biological product that contains cyclized peptides and small molecules separated from the blood to target multiple pathways in the innate immune response of inflammatory diseases
.
These ingredients work together to achieve anti-inflammatory effects and can be used to treat a variety of inflammations, including osteoarthritis, respiratory diseases and other inflammatory diseases
.
Image source: Ampio Pharmaceuticals official website
This phase 3 clinical trial uses the WOMAC A (pain subscale) index/scoring system as the pain measurement index and the WOMAC C (functional subscale) index/scoring system as the functional measurement index
.
Analysis of data from 725 patients showed that compared with the normal saline control group, after 12 weeks of treatment with Ampion, the patients' pain was statistically significantly reduced (p=0.
0260) and function was significantly improved (p=0.
In addition, Ampion showed good safety characteristics in the trial, and no treatment-related serious adverse events were observed in the cohort of patients treated with Ampion
Reference materials:
[1] Ampio Pharmaceuticals Announces Top-line Results from AP-013 Phase III Study of Ampion in Adult Patients Suffering from Severe Osteoarthritis of the Knee (OAK).
(The original text has been deleted)
