Benzinga | Sep 15, 2021 09:00AM EDT

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

* Ampio Pharmaceuticals Inc (NYSE: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.