Our findings on the role of blood in the brain and also coupled with data from human research that shows cerebral vascular pathology pathway, independent of amyloid, that might need to be separately targeted to achieve maximum therapeutic benefit, inspired us to be able to develop a first-in-class immunotherapy to neutralize blood toxicity. Of course, the challenge we had to overcome was that fibrin had a very protective function, which is coagulation and hemostasis, but also this detrimental function in inflammation...
Our findings on the role of blood in the brain and also coupled with data from human research that shows cerebral vascular pathology pathway, independent of amyloid, that might need to be separately targeted to achieve maximum therapeutic benefit, inspired us to be able to develop a first-in-class immunotherapy to neutralize blood toxicity. Of course, the challenge we had to overcome was that fibrin had a very protective function, which is coagulation and hemostasis, but also this detrimental function in inflammation. And we needed a pharmacologic tool to be able to separate these two functions of the molecule. So we developed a first-in-class immunotherapy that can selectively recognize only the inflammatory domain of fibrin without adverse effects in hemostasis. And this originally was a mouse monoclonal antibody that had high efficacy in blocking neurodegeneration and also blocking inflammatory pathways in Alzheimer’s disease models, highly linked with inflammation that we observe in also human Alzheimer’s disease patients. And this high efficacy of this antibody in neuroprotection as well as also low adverse effects of interfering with coagulation led to the rationale of moving it forward towards clinical development. The antibody has now been humanized, affinity matured, GMP manufactured. It has completed toxicology in two species, including nonhuman primates, and the Phase I trial in healthy volunteers started in May of this year.
