Shares were up by over ten percent on Monday after the company announced positive trial results for the orally-administered Optina in the treatment of diabetic macular edema (DME). The DME trial was conducted in Canada and based on the positive results Ampio has planned a pre-IND meeting with the US FDA as part of preparations to bring Optina through the approval process in the United States.
The meeting, according to Monday's press release, is slated for next month.
Optina, like the rest of Ampio's pipeline, is based on the strategy of 'repositioning' already-approved drugs to treat new indications, meaning that due to the fact that much of the safety profile is already established, the path to approval could be a lot quicker than it would be if the company was bringing an entirely new drug to market.
As is the case with results on the other of Ampio's pipeline fronts, the expected catalysts are playing out like clockwork, a factor that adds credibility to the company and its pipeline since results are being released right when the company says they are going to.
Interim results from the Optina trial were announced earlier this year and also led to a spike in share price as expectations to move forward with the FDA were then discussed.
Ampio is also moving forward with plans to bring Ampion, being positioned as a major player in the anti-inflammatory market, and Zertane in the treatment of premature ejaculation (PE) through the FDA approval process as well. Both products stand to enter very lucrative markets, if approved, and the company has already signed numerous licensing agreements for Zertane overseas.
Also in the pipeline, but not talked about as much as the 'big three' that are swiftly moving through the trial process, is the company's ORP diagnostic devices which are designed to measure a patient's oxidative stress. Measuring oxidative stress is believed to be a much more accurate measure of one's overall health than the standard set of 'vitals' taken on a patient when entering a Doctor's office, which many consider to be irrelevant to many of today's ailments.
The ORP line is worth keeping in mind when considering the potential overall value of the company.
Aside from the pending FDA discussions regarding Optina, Ampio officials will meet with the FDA this month to discuss an approval process for Zertane in treating the PE condition. The FDA has yet to declare PE as a medical need so Ampio is likely to come away from this meeting with a clearer picture of how to move forward in the US in conjunction with pushing for international expansion.
Last month officials from Ampio met with the FDA regarding a trial design for Ampion.
Already a stock to watch this week based on last week's volatility and Friday's move, AMPE continues to give reason for investors to remain interested.
Disclosure: Long AMPE.
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