An osteoarthritis trial ravaged by COVID, an FDA rejection, three failed clinical trials in COVID and now this: Ampio’s board is conducting an internal investigation and considering a sale.
The Colorado biotech has had a challenging couple years, to say the least. The mess all started about four years ago, when the FDA ruled that a clinical trial for the company’s osteoarthritis drug Ampion fell short of standards. Ampio moved to run another phase 3 study, which was later ravaged by the COVID-19 pandemic, resulting in missing data that the FDA also nixed.
Ampio was sure it had followed all the FDA’s advice on how to run a trial during COVID, but the FDA disagreed and said the data collected from the AP-013 study was not enough to prove efficacy of the company's lead drug candidate. After further analysis, the company has determined that it does not have the data package needed to support a regulatory approval for Ampion in the U.S. or other countries in this indication.
Moreover, three study attempts to develop the drug for COVID-19 have also failed, the company said Monday.
All of this has led the board to consult independent legal counsel and conduct an internal investigation. Meanwhile, the board is examining strategic alternatives for both the company and Ampion. This could include continued development of the drug, capital raising, licensing or other partnering opportunities. The company could also be sold.
But that’s not all: the investigation will also include an examination of unauthorized use of Ampion by people not participating in clinical trials. As the therapy is not approved by the FDA, it cannot be used outside of approved studies.
“Ampio instituted safeguards to cease this practice and engaged independent outside counsel to conduct a thorough review, which is ongoing,” the biotech said. “The company is currently in the process of working to ensure that the issue has been resolved, that appropriate mitigation measures have been implemented, and that this information is provided to FDA.”
Ampion is being tested in osteoarthritis of the knee and hand, COVID, kidney disease and pediatric disease, according to the company’s pipeline. Ampio has tried to position the therapy as a solution for multiple inflammatory conditions. The therapy contains a blood-derived cyclized peptide and small molecules to target the innate immune system response that occurs with inflammatory disease.
In reporting fourth-quarter earnings in March, Ampio reported that work was continuing with the FDA to try and get clarity on the AP-013 study. The company expected to soon have an idea of whether the study and an earlier one called AP-003-A would support a drug application for treatment of pain associated with severe osteoarthritis of the knee. In Monday's update, the company said the FDA has now made it clear that the trial is not enough.
The earnings report also signaled trouble for the COVID program, with Ampio reporting slow recruitment and a changing regulatory landscape. Many companies that were late to getting therapies into the clinic have faced dwindling funding and lackluster results as the omicron wave crested and hospitalizations dropped.
Already a penny stock, Ampio's shares tumbled a further 15% as the markets opened Tuesday morning from a prior close of 20 cents to 17 cents.