August 03, 2021
“In theory there is no difference between theory and practice. In practice there is.” ~Yogi Berra
While it’s sometimes hard to follow the logic of the inestimable Mr. Berra, in this case, it isn’t. In the life sciences, and particularly in the clinical development of therapeutics, the success of your plans is a product of the quality of the people you charge to execute your theories, in practice. Those of you who follow Curative know that we have made a concerted effort to recruit the inventors of the technologies we have licensed to help steer the “practice”. So, it should not be a surprise that we are talking to the National Eye Institute (NEI) at NIH about collaborating on the first clinical trials of our reformulation of metformin into an eye drop to treat age-related macular degeneration.
The first trial is being designed to treat patients with both intermediate dry AMD, and geographical atrophy, which you can think of as late-stage dry AMD. Macular degeneration is a leading cause of irreversible blindness and visual impairment in the world. As many as 15 million people in the U.S. alone and as many as 200 million people worldwide have some form of age-related macular degeneration and those numbers are expected to double over the next two decades as populations age. The risk of getting advanced age-related macular degeneration increases from 2% for those individuals in their 50’s to nearly 30% for those over the age of 75. The “dry” form of age-related macular degeneration accounts for approximately 90% of all the cases.
Age-related macular degeneration is a (currently) irreversible destruction of the macula, which leads to the loss of the sharp, fine detail vision required for activities like reading, driving, recognizing faces, and even seeing the world in color. At Curative, we believe that our patent-pending eye drop may slow down or even stop this degenerative process. It is possible for researchers to test and see the effects of our drug on the various mechanisms involved in this downward spiral, and the results are encouraging. However, there is no actual “animal” model that recreates the disease. The potential efficacy of this drug will only be revealed in well controlled clinical trials of actual patients.
And so that brings us back to the National Eye Institute. We have stated publicly that our goal is to have an IND filed with the FDA near the end of this year and be in clinical trials in Q1 of 2022. NEI is considered the gold standard in the world of ophthalmologic research. Indeed, most of the world’s other prestigious research institutes are “ranked” by how much support they receive from NEI. Our discussions with NEI are just that at this point, discussions. However encouraging those discussions are, no one should take this as a statement of anything else at this time. As Yogi also famously said, “It ain’t over ‘til it’s over.”