BIVV001 Clinical Trial Reviewed by HemoAware Founder

Updated: Sep 17, 2020

Over the weekend, HemoAware uploaded a video of founder, Jesse John Francis Clark, reviewing Sanofi's Phase 3 clinical trial for BIVV001. There is currently no commercial name for the product. According to a recent publication by the New England Journal of Medicine, a single intravenous injection of BIVV001 resulted in high sustained factor levels, with a half-life that is up to four times the half-life associated with recombinant factor VIII.

Clark stated in the video that he has been on the trial for almost a year now and that he has not had any bleeds during the trial. However, he did state that he has had elevated liver enzymes which may be due to workout supplements. He stated that he currently off all supplements and will go in for a blood test to see if the elevated liver enzymes are due to the supplements or if they are a direct result of BIVV001.

Clark's biggest gripe with the clinical trial is the use of a wearable device form Koneksa Health, a wearable technology company based in New York City. Koneksa Health was hired by Sanofi to provide all study patients a wearable watch that would track the patient's daily activity. Clark stated that the technology is outdated and that he has to physically connect the watch to a modem to upload data and that most of the data from the watch is not recorded. All wearables technology today is Bluetooth enabled and data is synced to an app. Upon investigation, Koneksa Health was founded in 2013 by Chris Benko and has raised over 9.6 million dollars in funding.

Clark stated that he would keep the community updated about the elevated liver enzymes and if he would continue with the trial.

BIVV001 Fusion Protein as Factor VIII Re
• 2.22MB