According to the Complaint, Ampio Pharmaceuticals, Inc. is a pre-revenue stage biopharmaceutical company focused on the research, development, and advancement of immunomodulatory therapies for the treatment of pain from osteoarthritis. The Company's lead product candidate, Ampion, purportedly has unique immunomodulatory action and anti-inflammatory effects, which may provide a treatment for individuals with inflammatory conditions including, but not limited to, osteoarthritis of the knee, osteoarthritis related to other joints (i.e., hip, shoulder, ankle and hand), and the widespread inflammation associated with COVID-19 infection.
The Complaint alleges that Ampio has misrepresented the efficacy of Ampion in treating individuals with inflammatory conditions. Beginning in 2010 until approximately March 2022, Ampio conducted numerous clinical trials and analyses to determine Ampion's efficacy. Despite confidently advertising on numerous occasions that Ampion demonstrated statistically significant decrease in pain associated in symptomatic moderate-severe OAK, the Company failed to bring Ampion to market.
On May 16, 2022, the Company announced it had formed a special committee to conduct internal investigations focusing on the statistical analysis of Ampio's AP-013 clinical trial and unauthorized provision of Ampion, which had not yet been approved by the U.S. Food and Drug Administration. Then, on August 3, 2022, Ampio revealed that "senior staff were aware, at the time of the per-protocol interim analysis in March 2020, that the AP-103 trial did not demonstrate efficacy for Ampion on its co-primary endpoints of pain and function, and that these persons did not fully report the results of the AP-103 trial and the timing of unblinding of data from the AP-103 trial." On this news, the Company's share price dropped $0.06, or 35.38%, from the previous day's close, on greater than usual trading volume.
On August 9, 2023, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on October 16.
On May 13, 2024, the parties entered into a Stipulation and Agreement of Settlement. The Court granted preliminary approval of the Settlement on September 24. On February 20, 2025, the Court granted final approval of the Settlement, including an award of Attorneys’ Fees and Expenses, and entered Final Judgment.
