I will be quite interested to see the new trial protocol and in particular what was decided on for primary and secondary endpoints. The NASH trial conducted by Cytodyn, while small, is a beacon into the biomarker data that is likely to be included in the upcoming HIV study. NASH as we know is fundamentally an inflammatory process mediated by immune function and the fact FDA is cross-referencing that study in evaluating and making recommendations on the new protocol is a strong hint they may be looking at CCL2, CCL3, CCL18, tumor necrosis factor receptor 2 (TNFR2), inflammatory interleukins such as IL-6 etc. TNFR2 is fundamental to the oncogenic process. This study, properly conceived and executed has a high likelihood of success, largely on the strength of already completed studies in NASH and COVID-19. I am sure the protocol designers have already factored this in but I did send a message to IR affirming the helpfulness of capturing discrete comorbidity data such as NASH to help tease out sub population impact when analytics are done. The data generated, while focused on immune-modulation in the HIV population might also serve to cast a spotlight for potential NASH partners on that population.

We owe a debt of gratitude to Chris Recknor and others that have put a microscope under the physiologic and immunological processes and I think in due course will gain a new-found appreciation for the foundation that has been laid even if the efforts did not lead to approval.

This is one study, one purpose, but the ramifications will clearly spill well beyond the HIV population. A hyper-miler if you will which may well temp BP into jumping aboard.