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The Motley Fool Australia »Stock Falls» Why Mesoblast (ASX: MSB) is down 45% today

James Mickleboro | 18th December 2020, 10:39 am | More on: MSB

The share price of Mesoblast Limited (ASX: MSB) has returned from its trading freeze and has fallen significantly

Investors sold the company’s shares this morning after it released an update on the randomized controlled trial of its Remestemcel-L product in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection

According to the press release, the Data Safety Monitoring Board (DSMB) carried out a third interim analysis of the first 180 patients in the study

The aim of the study was to achieve a primary endpoint of 43% less mortality after 30 days for treatment with Remestemcel-L in addition to maximum care in a study with 300 patients

This goal was based on pilot data observed in the early stages of the pandemic when control mortality rates were extraordinarily high.It was also ahead of new, evolving treatment regimens that have reduced disease mortality in ventilated patients

Although the DSMB reported that there were no safety concerns, it noted that the study is unlikely to meet the 30-day endpoint of reducing mortality with the planned enrollment of 300 patients

Against this background, the DSMB recommended that the study be terminated prematurely in only 223 patients included

Although the primary endpoint has not been met, management urges that the secondary endpoints be met

These include days without mechanical ventilation 60 days after randomization, overall survival, days in the intensive care unit, length of hospital stay, and damage to cardiac, neurological and lung organs

The company has suggested that changes in treatment regimen for COVID-19 patients are responsible for the failure of the study

It was stated: “Over the course of the study, as the pandemic evolved, there were numerous changes in the treatment regimen for COVID-19 patients, including before and during mechanical ventilation, which may affect mortality in endpoint the study ”

“These include advanced treatment of patients prior to ventilatory assistance and the use of experimental therapies such as dexamethasone, antivirals, and misappropriated immunomodulatory agents. All of these could alter the natural course of ventilated patients and overall mortality during the study compared to the early stages Pandemic, “he added

Readers may be aware that Mesoblast recently signed a contract with Novartis for Remestemcel-L that will initially focus on developing a treatment for Acute Respiratory Distress Syndrome (ARDS), including those associated with COVID-19

Novartis will also pay $ 50 million upfront and then more than $ 1 billion in milestone payments

This news appears to have raised concerns that this deal may not go through now

However, the press release recommends that “Mesoblast and Novartis both analyze these results to identify meaningful clinical results that can guide decisions about the development program for Remestemcel-L in non-COVID ARDS”

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James Mickleboro, contributor to Motley Fool, has no position in any of the stocks mentioned The Motley Fool Australia has no position in any of the stocks mentioned The Motley Fool has a disclosure policy This article provides general investment advice only (under AFSL 400691) Authorized by Bruce Jackson

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World News – AU – Why Mesoblast (ASX: MSB) stock is down 45% today