Since its foundation in 2008, Ampio Pharmaceuticals (NYSE: AMPE) has been focused on delivering a drug that treats inflammation caused by a wide range of disorders. The biopharma company’s flagship drug, Ampion, had already successfully completed Phase 2 trials for the treatment of severe OAK (osteoarthritis of the knee) when the pandemic struck last year.
Ampio then quickly shifted gears to simultaneously study the efficacy of the drug – through inhalation and IV – on inflammation caused by COVID-19. These multiple human clinical trials, if successfully completed, could open up a huge global market for the firm. The management estimates a ten-figure market for osteoarthritis treatment alone.
Alternative to steroids, surgery
In an interview with AlphaStreet, Ampio CEO Michael Macaluso said the drug will become a harmless and affordable alternative to steroids and hyaluronic acid, which are not FDA approved modes of treatment, as well as total knee replacement surgery. He said:
The most important thing about Ampion is that it does no harm. In all of our clinical trials, there has been no serious drug-related adverse events. We have an anti-inflammatory drug to treat a multitude of conditions, even very severe ones, and still doing no harm.
Last year, the pandemic had forced the Englewood, Colorado-based firm to cut down on the number of patients enrolled for the OAK trials. Even though the FDA has provided the firm an option to continue the trials with fewer patients, investors have been concerned over a delay in approval if efficacy standards were not met.
While stopping short of making an official statement, Macaluso expressed confidence based on historical data that shows the number of patients that remain unblinded to be enough to create statistical significance. The official announcement, the chief executive said, will be happening soon.
COVID trials
Speaking about the COVID trials, Ampio VP Laura Goldberg told AlphaStreet that the availability of vaccines should not impact the market for its inflammation drug. She said:
“Since Ampion targets the inflammation, it not competing with the vaccine. It’s treating the population up until we can have an effective vaccine, while we are rolling out one, or in the case that the virus mutates and the vaccine is no longer effective like you see with the flu.”
While the intravenous (IV) infusion trial addresses the inflammation caused in the lungs, heart, and kidney due to COVID-19 infection, inhalation therapy is done to study the efficacy on localized inflammation in the lungs.
Financially comfortable
The CEO said the management is comfortable with the firm’s current balance sheet, despite the increasing nature of expenses related to clinical trials. He added that the company does not consider additional fundraising in the upcoming quarters, unless it decides to go ahead with a 1000-patient trial for OAK, or if it deviates from the current plan of action for some reason.
As of September 30, 2020, Ampio had $9.36 million in cash and cash equivalents.
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To learn more about Ampio Pharmaceuticals, read the latest earnings call transcript here.