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- Stem cell specialist Mesoblast (MSB) has received approval from the Data Safety Monitoring Board (DSMB) to keep going with its COVID-19 clinical trial
- The company is running a phase three clinical trial to test its remestemcel-L drug on patients with acute respiratory distress syndrome (ARDS) caused by COVID-19
- The DSMB reviews clinical trials to determine if the drug is either effective enough that it should be fast-tracked to market or ineffective enough that testing should be stopped altogether
- For Mesoblast, the DSMB reviewed the trial after 30 per cent of the total target of patients completed 30 days of follow-up
- This means safety and efficacy data from the first 90 patients were reviewed by the DSMB
- The trial is planned to recruit up to 300 patients, with recruitment expected to be complete during the final quarter of 2020
- Shares in Mesoblast are trading a slight 0.78 per cent higher this morning, currently worth $5.14 each
Stem cell specialist Mesoblast (MSB) has received a tick of approval from the Data Safety Monitoring Board (DSMB) to keep going with its COVID-19 clinical trial.
The company has been running a phase three clinical trial to test its remestemcel-L drug on patients with acute respiratory distress syndrome (ARDS) caused by COVID-19.
ARDS is the leading cause of death from COVID. Essentially, the condition is a type of respiratory failure when air sacs in the lungs fill with fluid and organs become deprived of oxygen.
Mesoblast has been testing remestemcel-L for treating COVID-10-induced ARDS after the drug was proven effective in patients with pneumonia.
Why the DSMB review?
The DSMB generally looks at efficacy and futility when deciding if a trial should be stopped or not. If the drug being tested is proven to be vastly superior to its peers, it’s often better to stop the trial early so it can get to market quicker — the best-case scenario.
On the inverse, if the drug is proven completely ineffective, there DSMB will recommend that there is no point continuing on with the trial.
Mesoblast’s trial is both randomised and double-blinded. This means, firstly, all trial patients will be randomly treated with remestemcel-L or a placebo. Secondly, the scientists conducting the test don’t know which patients are receiving the real treatment and which are receiving the placebo. This is often done as a way to eliminate bias when reporting.
This means for Mesoblast, the DSMB knows which patients received which treatment, but will not communicate this information nor any details of its review to the investigators or patients of the trial.
Mesoblast’s trial is slated for three interim analyses from the DSMB: first when 30 per cent of the total target of randomised patients have completed 30 days of follow-up, then 45 per cent, then 60 per cent.
Remestemcel-L gets green light
Today’s DSMB review was the first of these three analyses — meaning 30 per cent of the total target of randomised patients have been reviewed. Following the review, the DSMB recommended the continuation of the trial.
With Mesoblast being given the go-ahead, this means the remestemcel-L product is so far proving to be effective enough that it’s worth exploring further, but not effective enough that it warrants a fast-track to market.
Mesoblast Chief Medical Officer Dr Fred Grossman said the company is pleased with the DSMB recommendation.
“This important trial seeks to confirm whether remestemcel-L improves survival in ventilated COVID-19 patients with moderate to severe ARDS, where death rates remain high despite best existing treatments,” Dr Fred said.
The trial’s primary endpoint is all-cause mortality within 30 days of randomisation. Essentially, this means the main measurable outcome of the trial is how many trial patients die within 30 days of treatment.
The secondary endpoint for the trial is the amount of days trial participants are able to stay alive without a medical ventilator within 60 days of treatment.
Mesoblast plans to recruit up to 300 patients, with final recruitment expected to be complete during the final quarter of 2020.
Shares in Mesoblast are trading a slight 0.78 per cent higher this morning, currently worth $5.14 each.
