Shares of Ampio Pharmaceuticals (AMPE) have rebounded by roughly three bucks over the past few weeks as many major catalysts are set to materialize later this year and eary next. As the latter stages of development of the company's 'respositioned' pipeline are being transitioned for the commercial phases, Ampio recently boosted its management team with addition of Dr. Deborah Knobelman, a move that immediately strengthens the company's position in initiating the next chapters in Ampio's rapidly-developing history.
The most immediate chances for this company to bring a product to market lay with Zertane, a repositioned pain medication that has already been on the market for years and is planned to be introduced by Ampio to market as a treatment of premature ejaculation (PE). The target markets for the treatment will all be outside of the United States, for the time being, since the US FDA does not recognize PE as a qualified medical condition. Although I'm sure the female population of the US would disagree with that ascertain by the FDA, those are the facts.
The company announced this week that data from the clinical Phase III Zertane trials will be published in 'European Urology.' This is a significant event for Ampio, as European Urology has an extensive global reach, with more than 20,000 urologists across the globe included in its readership. Given that Zertane is being prepped for commercial launches and potential partnerships in both Europe and Asia, there's no time like the present time to start getting the word out.
Shares of AMPE look to have settled for the time being in the mid-$7 range, but if key developments and catalysts continue to materialize, Ampio could quickly turn into a major growth story.
Aside from the commercialization of Zertane, multiple clinical trials for the company's other product candidates are set to finalize over the next quarter or two.
Lead product Ampion, for example, is being developed to target the $80 billion anti-inflammatory and autoimmune disease markets. The advantage of bringing Ampion through trials and to market in quicker-than-normal fashion is that it is a biologic - a molecule already produced by the human body (as albumin). Because it is a natural part of the body and because it is already commercially available, it already has an established safety profile.
The company has targeted osteoarthritis (OA) in the knee as the first potential use for Ampion, and the completion of an ongoing trial fir this indication are expected before the end of the third quarter.
Also on the plate is Optina, an oral drug for the treatment of diabetic macular edema (DME) and diabetic retinopathy. This product candidate is being "repositioned" to treat the said indications from the already-approved Danazol. It was found that Danazol, when used in very low doses, actually reverses the effects it demonstrates when used at higher doses and was therefore repositioned by Ampio to treat the horrendous eye conditions that can occur as a result of diabetes.
Again, because Danazol is already commercially available and has been used in humans for some time, the safety profile is established. Results from an ongoing trial in Canada should be released by the end of this year, adding another potentially major catalyst to Ampio's short term future.
In addition to the repositioned products in the pipeline, Ampio a pipeline of diagnostic technology being developed, as well, which - if ultimately approved - could change the face of measuring vital signs for patients being seen for various critical ailments, such as heart attack and stroke.
Ampio’s ORP diagnostic device, for example, is a hand-held, point-of-care unit that measures a patient's total oxidative stress, which, according to the Ampio website, can be considered much like the vital signs routinely measured in medical practice – temperature, heart rate, respiratory rate, blood pressure and pulse-oximetry (“pulse-ox”). Abnormal ORP results are closely associated with poor outcomes in critically ill patients, offering a wide scope of potential applications should this device receive regulatory approval.
Clinical studies for the ORP device are ongoing.
With AMPE shares having rebounded, and the story starting to get out, it's worth keeping this one on the scope as a potential grower as multipe products are being conditioned to enter multi-billion dollar markets.
Disclosure: Long AMPE.
