| Potentia Pharmaceuticals – Recruiting |
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This Phase I study (called ASap) will provide safety and tolerability information on the complement inhibitor (POT-4) injected into the eyes of patients with wet AMD. Earlier animal studies showed no toxicity even when injected at high concentrations. Participants received a single injection of the drug, with some patients receiving higher doses than others. This is a one year study, but information from the early data is being released.
At 3-6 months blood was tested and showed that there was a slow release of the drug. Safety was excellent. In the one group assessed so far, vision was stable in most patients and improved in a few. Because of this result, there will be an increased number of patients for a Phase II study that will hopefully open soon.
POT-4 affects the body’s “complement” system. The complement system is designed to block inflammation and inflammation plays a role in developing macular degeneration. So one approach is to figure out a way to trigger the complement system and stop the inflammation. Eight complement proteins are associated with AMD and POT-4 affects the one called C3, which seems to be a critical one. The problem is that inflammation is useful in fighting infections. If you completely shut down the complement system, you increase the development of bacteria in a major way. So using this system has to be targeted to the retinal inflammation without disturbing the patient’s ability to otherwise fight infection. The first thing researchers had to do was identify all the complement factors and their various pathways. Then, they looked at which ones played significant roles in macular degeneration. Now, they are working with different models to see how effective each one can be in blocking the development of AMD. Click here for more information. |
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