EXCLUSIVE: Ampio's Ampion Shows Benefit In Late-Stage Knee Osteoarthritis Study

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.

Market News and Data brought to you by Benzinga APIs

Comments

Popular Channels

Tools & Features

Partners & Contributors

About Benzinga