probably only about 8 million are in active therapy, because the therapies just aren’t very good.
Nonetheless, this is over a $35 billion treatment market today, and it’s growing at 5-7% a year, driven by an aging population, and the increasing incidences of obesity, and diabetes. So we’re focused on a large market opportunity.
|Ana: Can you tell us a little bit more about the OA-201? Why do you think it will “work” when Ampion didn’t?
Mike: So, let’s start with Ampion. That was an ultra-filtrate of Human Serum Albumin which is a biologic, and Ampion consisted of three active ingredients that resulted from that filtration process. But as a filtrate of that biologic substance, the concentrations, and potencies of those active ingredients in the finished drug product, i.e. Ampion, were identical to the concentrations, and potencies in the starting material, Human Serum Albumin.
This is really important, because our detailed review of the over 1,500 patients that enrolled in Ampion trials suggested to us that the drug just wasn’t potent enough. In other words, there were clear trends and signals that Ampion reduced both pain and improved function in osteoarthritic knee patients but we could never consistently get over the statistical hurdle of proving superiority to controls required for FDA approval.
Those observations led us to explore an approach that enabled us to selectively increase concentrations and potencies and experiment with different combinations of those between the three ingredients. And frankly, what we ultimately concluded is that only one of those original ingredients delivered efficacy.
So, OA-201 is a small molecule drug. It consists of one active ingredient, that active ingredient is a natural metabolite, it’s formulated in much higher concentrations than in Ampion. And again, now in repeated preclinical studies, we’ve demonstrated superiority in both pain reduction and cartilage preservation to both controls and to Ampion.
|Ana: So, OA-201 is kind of a “new and improved Ampion”? Can you tell us about some development plans as well?
Mike: Well, I might think of it a little bit differently, because OA-201 is really a distinctly new drug with new and unique intellectual property that is not dependent on Ampion. We did start with Ampion because there was a significant clinical experience to learn from and we focused on how we could improve its potency and that resulted in OA-201, but it’s not really Ampion.
So, in terms of the program, I think you know I’m scheduled to be back with you in November, and my plan is to lay out a detailed development program, including timelines and budgets, at that point in time. What I can tell you today is that we have submitted a pre-IND meeting request to FDA. We expect to have their feedback on the questions and that request by the end of this year. That will put us in a position to file our IND and