Things might be heating up for Ampio Pharmaceuticals (AMPE) as key developments have led to a share price recovery following a brief dip back into five dollar territory last month. The drop was not supported by any developments on the news front, but could have been attributed to some lingering short interest and a slump in the biotech/pharmaceutical sector as a whole following dismal news from the likes of Dendreon (DNDN), Ilumina (ILMN) and Human Genome Sciences (HGSI) over the past few months.
The AMPE rebound, on the other hand, goes hand in hand with the progress of the company's pipeline.
As previously discussed, Ampio has been making headway in bringing Zertane to market around the globe for the treatment of sexual dysfunction. Following positive Phase III trial results which were published in Europe this summer, Ampio secured a partnership and licensing deal with Daewoong Pharmaceuticals, which puts the commercialization plan in motion as the rest of the pipeline develops.
Next up is lead product Ampion, for which a late stage trial in Australia measuring its effect in osteoarthritis (OA) in the knee has been underway. An announcement last week revealed that the treatment phase Ampion-in-Knee (AIK) trial has been completed and that data is going to be compiled and released in the "coming weeks."
The trial was composed of sixty patients diagnosed with moderately-severe to severe osteoarthritis of the knee and any success here could ignite a series of events that catapults Ampion straight into the heart of an $80 billion anti-inflammatory and autoimmune disease market. Alternatives to common anti-inflammatories are being searched for in the medical community due to concerns of side effects, and an Ampion thrust into that market could come relatively quickly given its status as a biologic - a molecule already produced by the human body (as albumin) and an already-established safety profile.
These results mark another key development for Ampio this year, and the coming weeks could see additional interest drawn to the company stock given the Ampion news.
Additionally, Ampio also announced last week that information and data from Ampion development is set to be presented at San Fransisco's American Association of Orthopedic Surgery (AAOS) meeting this coming February. Included in the presentation will be a publication describing "a study of 22 patients undergoing surgical removal of orthopedic devices in which all the extracted biofilms were found to contain various levels of the low molecular weight diketopiperazine- Ampion™ (composed of the cyclic dipeptide of aspartate and alanine)."
The pipeline of potential products doesn't not stop with the above-mentioned candidates, however. Results could come by the end of the year for an Optina trial,as well, which is taking place in Canada. Optina, another of Ampio's products based on the strategy of taking already-approved drugs and using them to treat new indications, is being tested as an oral drug for the treatment of diabetic macular edema (DME) and diabetic retinopathy.
Optina has been repositioned from Danazol, which has already been commercially available for years, giving it an already-established safety profile. Those facts could greatly reduce its time-to-market potential.
In addition to the repositioned products in the pipeline, Ampio has a pipeline of ORP diagnostic technology being developed. Should the ORP pipeline reach the approval stages and infiltrate the routine and critical care markets, the standard of how a patient's vital signs are measured could be shifted. Rather than using the routine standards of today's methods of checking for vital signs, Ampio's ORP diagnostic device measures total oxidative stress, which may prove more beneficial and thorough for patients being seen for indications such as heart attack and stroke. Abnormal ORP results are closely associated with poor outcomes in critically ill patients, which offers a wide scope of potential applications should this device receive regulatory approval. Clinical studies for the ORP device are ongoing, and well worth watching for updates.
Ampio opened the month on a downtrend, but the brief dip into the fives was quickly reversed, and the developing stories surrounding Ampion and Zertane provide the ammunition to support growing interest to this company.
All products in the Ampio pipeline are being positioned to enter very lucrative markets, so this is a company whose stock has been on the rise that still could have more to come.
Disclosure: Long AMPE.