- Ampio Pharmaceuticals Inc AMPE has reported top-line results from the AP-013 Phase 3 trial evaluating the Company's intra-articular (IA) injection of Ampion in adults with pain due to severe osteoarthritis of the knee (OAK).
- Related Link: Ampio's Phase 2 Study Of Inhaled Ampion In COVID-19 Patients Gets Underway.
- The AP-013 study was paused in early 2020 because of the pandemic, and the FDA provided Ampio with guidance.
- The FDA recommended identifying subject information impacted by the pandemic during the AP-013 study and conduct a sensitivity analysis to detect potential biases related to the pandemic. The Company completed a top-line analysis and performed the FDA-recommended sensitivity analysis.
- The resulting data demonstrate a statistically significant impact from the pandemic.
- A separate statistical analysis of data from the 725 patients believed not to have been impacted by the pandemic demonstrated a statistically significant reduction in pain and improved function at 12 weeks with Ampion treatment compared to saline control.
- Ampio plans to analyze and consolidate all the study data and present it to the FDA in support of a marketing application.
- On the safety front, no treatment-related serious adverse events were observed among the cohort of patients who received Ampion.
- In June, Ampio reported newly integrated data from four of its earlier clinical trials with OAK patients.
- The pooled data showed statistical significance, with a reduction in pain of 34.3% at two weeks (compared to 28.6% for saline), 38.1% at ten weeks (30.4% for saline), and 36% at twelve weeks (25.7% for saline).
- Read Next: Ampio Pharma's Inhaled COVID-19 Treatment Shows 78% Improvement In All-Cause Mortality.
- Price Action: AMPE stock is trading 0.69% higher at $1.45 premarket on the last check Wednesday.
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