For months Ampio Pharmaceuticals (AMPE) has been releasing a steady dose of positive pipeline updates, which have included positive trial results for lead product Ampion in the treatment of osteoarthritis in the knee (OIK), and a licensing deal for Zertane in the treatment of premature ejaculation.
That trend continued last week when the company announced positive results from yet another study involving Ampion, this one for the treatment of nasal inflammation. According to the results of the study, which was conducted at the Centers for Allergy and Asthma in Denver, Colorado, Ampion provided "safe and effective anti-inflammatory relief when administered intranasally to patients with nasal inflammation."
This trial marks a milestone for the company and the progression of Ampion as it is the first time that the product was used as a stand-alone treatment for an inflammatory condition. Taking these results in conjunction with the previous OIK results, and there's reason to believe that Ampio is making significant headway in introducing Ampion to the medical arena as a potential major player in the anti-inflammatory market.
As previously discussed , Ampion appears as a molecule produced by the human body (as albumin) and is a considered a biologic, which means that the path to an FDA approval could be drastically reduced when compared to bringing a completely new drug to market. For this reason, the progression into further studies and approvals around the road may not be that far off.
Given the recent string of news, shares of AMPE have steadied at right around the seven dollar mark, but other catalysts are still pending that could draw in additional investor attention.
An ongoing Optina trial for the treatment of diabetic macular edema (DME) is due to conclude within months, and results from that trial may be released as soon as early 2012. Optina, like Ampion and Zertane, may also hold an accelerated path to approval, given that it already has an established safety profile since it is effectively a repositioned indication for the already-approved Danazol.
In addition to the above-mentioned repositioned products, Ampio has a pipeline of diagnostic technology being developed, as well. These diagnostics measure a patient's total oxidative stress, which may prove to be a more beneficial snapshot of a patient's health than the standard vital signs that are taken at just about every visit to the doctor's office. Should these diagnostics make their way to market, they could quickly change the face of how a patient's vital signs are measured. Measuring a patient's oxidative stress, for instance, could be a more thorough measure of health for patients being seen for more serious indications such as heart attack and stroke.
Although the all-encompassing potential of the Ampio pipeline is only just now coming to light, its the potential implications of Ampion on the anti-inflammatory market that is starting to steal the show. There's few - if any - anti-inflammatory medications currently out there that are not accompanied by some sort of side effects, and Ampion could be seen as a healthier, more reliable alternative to the current standard-of-care, should these early trial results continue through to approval.
Given that the anti-inflammatory market is a multi-billion dollar industry in itself, this will be one worth watching.
As will updates from the rest of the Ampio pipeline, which should continue to roll out over the coming months as potential catalysts come to fruition.
Disclosure: Long AMPE.