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As the COVID-19 pandemic continues to spread at an unprecedented speed attacking the lungs of individuals irrespective of their age, society and medical history, healthcare companies are intensifying their efforts to fight against the infectious disease with accelerated schedules for producing novel vaccines and commencing clinical studies for potential treatments.
Generally, the development of a novel vaccine or a treatment would take years. But this time the healthcare industry is fighting to compress this timeline with the support of nonprofit organizations, regulatory as well as government agencies.
Do Read: Medical Developments in Race Against COVID-19
While the number of confirmed cases of the coronavirus infection continue to rise steeply, healthcare researchers worldwide are working diligently for discovering new medicinal innovations for saving lives.
As on 9 April 2020 (at 10:00 AM AEST), according to the data collected from WHO, there are approximately 1.4 million confirmed cases of coronavirus across the world, with the disease accounting for 81,580 confirmed deaths.
The developments healthcare companies are working on could be planned into three different groups:
The critical factors those are accountable for growing investors’ concern in the healthcare sector include novel and innovative drug discoveries, Food and Drug Administration (FDA) approvals, demographics, patents and patent application, and ongoing clinical trials.
Particularly, the FDA approval process is a crucial characteristic that provides a decent recommendation on the destiny of any healthcare share. Generally, the share price of a company tends to upsurge if it receives a new drug approval from the FDA. Nevertheless, to avoid the failures of drug approval, investors should consider the approval process and the Company separately.
In this article, we will acquaint you with the development of a cellular medicines company Mesoblast Limited which is continually working towards the development of treatment for COVID-19.
Challenging this pandemic, Mesoblast continued its operations. As the Company has a robust drug pipeline with its candidates under clinical examination, it is well-positioned to progress treatment for COVID-19 patients. Mesoblast has recently received approval for its drug candidate Remestemcel-L from the FDA for treatment of acute respiratory distress syndrome (ARDS) in COVID-19 infected individuals and revealed about its evaluation in a randomized, placebo-controlled trial.
Let us delve deep -
Mesoblast Limited (ASX:MSB), Share price up by ~36%
Melbourne, Australia headquartered ASX listed healthcare sector company Mesoblast Limited is a leader in development of innovative cellular medicines at international level. Mesoblast has a robust emerging drug pipeline for follow-on signs with 3-programs currently in Phase 3 clinical studies.
Remestemcel-L, revascor, MPC-06-ID and MPC-300-IV are the lead product candidates of the Company that are under clinical research.
Stock Information:
On 9 April 2020, MSB stock settled the day’s trade at $2.500, up by 36.24% with a market capitalisation of nearly $985.9 million. The MSB stock has ~537.27 million outstanding shares on the ASX.
After FDA cleared the investigational new drug (IND) application for Mesoblast to use Remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19, the Company on 9 April 2020, updated the market that its allogeneic mesenchymal stem cell (MSC) drug candidate remestemcel-L will be formally evaluated in the clinical trials for acute respiratory distress syndrome (ARDS) caused by COVID-19.
To Know More, Do Read: Mesoblast Receives FDA Green Flag for COVID-19 Drug Application
Mesoblast’s randomized controlled trial of Remestemcel-L
Mesoblast has partnered with the cardiothoracic surgical trials network (CSTN), established by the US National Institutes of Health (NIH), to conduct randomized controlled clinical study focusing on the treatment of patients with acute respiratory distress syndrome (ARDS) due to COVID-19 with remestemcel-L.
The Company highlighted that Remestemcel-L would now be officially assessed in a randomized, placebo-controlled, multi-center Phase 2/3 study in 240 patients with COVID-19 triggered ARDS.
It is noteworthy that Mesoblast holds an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) for the use of remestemcel-L in the treatment of patients with COVID-19 ARDS and will test its investigational product in the clinical trial.
Brief about Mesoblast’s Remestemcel-L:
Remestemcel-L is currently under development for a variety of types of inflammatory diseases. The drug is supposed to counteract the inflammatory processes concerned in the diseases by snowballing anti-inflammatory cytokines production, down-regulating pro-inflammatory cytokine production, and hence, allowing recruitment of natural anti-inflammatory cells to involved tissues.
Moreover, it is noteworthy to mention that the safety and therapeutic effects of intravenous (IV) infusions of remestemcel-L have been assessed in over 1,100 individuals in several clinical studies.
The drug candidate Remestemcel-L has also shown positive results from a steroid-refractory acute graft versus host disease (aGVHD) Phase 3 trial in children, which is a potentially fatal inflammatory disorder due to related cytokine storm process as is witnessed in ARDS induced by coronavirus infection.
In addition, a post-hoc examination of a randomised, placebo-controlled study in nearly 60 patients having COPD exhibited that this drug significantly improved respiratory function in patients with the identical upraised biomarkers of inflammation that are also observed in COVID-19 ARDS patients. Collectively, these findings in different studies justify estimation of remestemcel-L in individuals with COVID-19 ARDS.
Interesting Read: How FDA approvals can change the fate of healthcare stocks?
