Ampio Pharmaceuticals (AMPE) is blaming a mini Polar Vortex for blowing up a pivotal study of its osteoarthritis drug Ampion.
Apparently, shipments of Ampion and a placebo were exposed to freezing temperatures before the phase III study began, which might have messed with the drug's efficacy and safety. Ampio only just discovered this problem, so analysis of the study results -- expected this quarter -- will now be delayed, or the entire study may have be thrown out, the company claims.
Wowza. I've seen plenty of lame excuses for failed clinical trials in my day, but "the freezer killed my drug" is certainly creative.
Nonsensical, too. Let's unpack the absurdities.
Pivotal clinical trial drug specifications dictate precise temperature and handling conditions for all study drug product in order to assure that the conclusions about the safety and effectiveness of the tested drugs will be accurate and repeatable during routine clinical use. During the review of all documentation following the unblinding of the Study, our CRO determined that there were multiple instances where the in-package temperature monitor fell significantly below the 15 degrees C minimum required.
Ampio only discovered the Ampion temperature problem after the phase III study was unblinded. This means Ampio has the study results but is choosing not to disclose. The only "delay" appears to be in telling investors the Ampion osteoarthritis study failed.
What is so special about Ampion that it must be kept above 15 degrees Celsius? That's the equivalent of 59 degrees Fahrenheit. If Ampion requires refrigeration, as some drugs most definitely do, the storage temperature would be around 40 degrees Fahrenheit. Requiring storage above 15 degrees Celsius, or 59 degrees Fahrenheit, doesn't sound like a product which requires refrigeration. Is Ampio telling us that Ampion is so fragile that it can't tolerate being stored in temperatures below 59 degrees Fahrenheit?
Although our entire trial drug supply was housed, packaged, and shipped in early January by a specialized drug shipment vendor contractually obligated to maintain pre-determined temperature requirements under all conditions, our CRO discovered much of the drug product received at the clinical sites had been below the temperature requirement and may have been frozen for some period of time. The drug temperature specifications were set because Ampion may lose potency if it is exposed to temperatures approaching freezing. We have contacted the FDA who has agreed to analyze the STEP trial as supportive data for our BLA.
Pre-determined temperature requirements? Like in the back of an unrefrigerated truck at room temperature?
Ampion is manufactured from human serum albumin, which can be stored between 2 degrees and 25 degrees Celsius. If albumin can be refrigerated down to an almost frozen state, then why can't Ampion also be refrigerated? Ampio claims its study blew up because Ampion's storage temperature fell below 15 degrees Celsius. But that makes no sense given the storage requirements for human serum albumin, the essential building-block component of Ampion.
Perhaps Ampio is using the temperature excuse to deflect from the fact the Ampion osteoarthritis study failed?
Ampio has a lot more explaining to do.