No surprises. 

 The decision by the independent Data Safety Monitoring Board (DSMB) to continue Mesoblasts 300-patient clinical trial into Covid-19 ARDS was entirely as anticipated. 

The independent DSMB are the only people allowed to check the data produced by the trial and despite some people’s opinions I’ve heard, they will not leak the data. 

To ensure the integrity of the trial, it is “double blinded”. In a nutshell this means that none of the doctors, patients, sponsor (Icahn School of Medicine at Mount Sanai) or collaborator (Mesoblast) get to look at any of the data until completion of the trial. No, not even a peek.   

News that the trial was told to continue resulted in mixed reactions on stock markets. On the ASX, MSB was down, then up, then down again on the news, finishing down almost 3% while the ASX fell around the same amount. 

In New York trading, MESO ADRs were down almost 15% at one stage during Friday trading, before recovering to be down a little over 6%. This wild price action suggests that many traders were expecting the trial to be stopped for overwhelming efficacy at the first interim look at the data.  MESO later recovered to finish down a little over 6% 

It was always going to be a staggering achievement to stop the trial for efficacy at the first interim analysis. In last week’s blog post I out lined the reasons why. You can read that post here: 

 .https://undiscoveredbiotech.com/2020/08/30/fasten-your-seatbelts/ 

Despite the announcement that the trial will continue, we may not have to wait too long until the next interim look by the DSMB as they have another peek at the data at the 135-patient mark.   

The rate at which patients are enrolled in the trial has likely increased since the early stages of the trial so it’s entirely possible that we could have an announcement on next interim analysis from late September onward. 

Regardless of whether a September decision is made on the Covid-19 ARDS trial, there is one massive outcome that will definitely drop by the end of this month – The FDA decision on Mesoblast’s treatment for pediatric Graft Versus Host Disease.  

One way or another, September is going to be a historic month for Mesoblast. 

 

Author – Ratfink


3 Comments

harymeso · September 8, 2020 at 10:01 am

Only just getting my uneducated mind around stats. Now realise it was too high an expectation to think we could get through at 90 patients. Think we should be more careful in expectations around the 135 mark.

    ddwn · September 8, 2020 at 2:40 pm

    I’m now thinking that we are unlikely to stop on the 2nd interim analysis either. (But, happy for it to stop though)

    We are more likely to stop on the 3rd interim analysis.
    By then, we are looking at 180 patients, that will be substantial; with some secondary endpoints too.

    Also, all patients would have been recruited by then, so there’s no loss of data to stop the trial early.

Ratfink · September 8, 2020 at 9:21 pm

The secondary endpoints provide vital data for clues into possible future new uses for Remestemcel. The more data, the more accurate it will be 🙂

Leave a Reply

Avatar placeholder

Your email address will not be published. Required fields are marked *