Ampio Pharmaceuticals Inc (NYSEAMERICAN: AMPE) has been doing the wave this morning, up as much as 4% and down just as much so far in the premarket this morning. The movement comes after the comapny announced that it would suspend enrollment in a Phase 3 trial so that it has the time and resources to focus on a potential COVID-19 treatment. Here’s what’s going on:
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AMPE Stock Is Volatile After Change In Focus
Ampio Pharmaceuticals issued two press releases this morning. The first of these releases was to let investors know that it had suspended patient enrolment in a Phase 3 trial. The trial was designed to assess Ampion for the treatment of severe osteoarthritis of the knee.
In the release AMPE said that the Safety Monitoring Committee for the trial unanimously recommended that the study stop enrolling. The recommendation had nothing to do with the efficacy or safety of the drug. Instead, the halt was the result of extenuating circumstances relating to the COVID-19 virus.
To reduce risk to participants, the study will no longer enroll new patients. However, in the study, 1,019 patients have been injected. The Safety Monitoring Committee believes that this number is a sufficient sample size to provide adequate data.
At the end of the release, AMPE said that it is currently focused on investigating the potential use of nebulized Ampion for the treatment of serious complications associated with COVID-19, which leads us to the second press release issued by the company this morning.
AMPE Provides An Update On Its Coronavirus Work
In the second PR, Ampio Pharmaceutcials said that it is preparing an expanded access FDA protocol for the study of nebulized Ampion in SARS-CoV-2 induced Acute Respiratory Distress System. Essentially, ARDS is how COVID-19 is killing people.
At the moment, Ampion is approved for clinical use by the FDA as an anti-inflammatory, immunomodulating drug. This is important because chemical signals leading to inflammation in the lungs are an important aspect of ARDS. If this inflammation is controlled, we will essentially see less death as a result of the condition.
Investors Should Be Excited Here
Any time a trial ends early, it’s a scary thing for investors. At the end of the day, it’s important to have enough data to achieve approval. If this doesn’t happen, new, expensive, and time consuming studies will likely be the result.
Nonetheless, AMPE made a couple of important points. First and foremost, the Phase 3 trial that stopped enrolling has enough patients to produce meaningful data. So, the fear that there won’t be enough data to reach approval, if that data is positive, should not be there.
Perhaps more importantly, COVID-19 is a very searious condition that is spreading around the world like wildfire. Ampion has already been shown to reduce inflammation, and inflammation in the lungs is the big issue with ARDS, the most serious of complications caused by COVID-19.
It’s also important to keep in mind that more than 1,000 patients were dosed with Ampion and no serious adverse events were reported. In fact, the safety profile was overwhelmingly positive.
Considering this, should the drug prove to be effective in coronavirus, the company is sitting on a figurative goldmine. At the same time, investors have plenty of catalysts to look forward to as the oseoarthritis trial nears a close and a potential FDA approval is ahead.
The bottom line is that if you’re not watching AMPE closely, you’re missing out.
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