Many of my readers know that over the last 12 month I’ve been participating in a clinical trial for a new drug called BHT-3021.
According to the manufacturer, “BHT-3021 is a plasmid encoding proinsulin designed to tolerize the immune system to proinsulin, thereby turning off the self directed immune attack. This product candidate’s potential to improve glucose control could reduce or eliminate insulin dependence and long-term complications of T1D, which would address a major unmet need and capitalize on a significant commercial market opportunity”. In plain words, the drug is meant to help your immune system get used to pancreatic cells, and potentially stop the autoinmune disease.
After 12 weeks of participating in the trial, my insulin requirements started to go up, so I wasn’t very positive about the whole thing. In the last couple of weeks I’ve received a three pieces of news that have refreshed my optimism.
I received the first (and personally most important) piece of information when my trial results were unblinded a couple of weeks ago. As it turns out, I was initially given the placebo and not the active drug. What this means for me is that my personal experience is not really indicative of the effectivenesss of the drug.
I have also seen some of the preliminary study data, and it looks like the drug does indeed slow down the immune attack, which means that the drug may be effective after all. According to the study, “In the current phase I/II trial, patients receiving BHT-3021 demonstrated preservation of C-peptide and an acceptable safety profile.”
Lastly, there is the news about the partnership between Bayhill Therapeutics (the drug developer) and Genentech (part of the Roche group) for the commercialization of the drug. This is a huge endorsement and means that there is a serious interest in the drug.
I’ve now been offerend the active drug at the optimun dose, so I will keep updating my experience with the trial. Let’s hope that this is the breaktrhough we’ve been hoping for.