Second Interim Analysis of Clinical Outcomes After 135 Patients Results in Recommendation to Continue Remestemcel-L Phase 3 T...
November 11 2020 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that the
randomized controlled Phase 3 trial of remestemcel-L in patients
with moderate to severe acute respiratory distress syndrome (ARDS)
due to COVID-19 infection had received a recommendation to continue
from the independent Data Safety Monitoring Board (DSMB) following
completion of the trial’s second interim analysis. The analysis was
performed on the trial’s first 135 patients, 45% of the total
target of up to 300 randomized patients, with the DSMB recommending
continuation after reviewing the trial’s primary endpoint,
all-cause mortality within 30 days of randomization and all safety
data. The key secondary endpoint is days alive off mechanical
ventilatory support within 60 days of randomization.
Mesoblast Chief Medical Officer Dr Fred Grossman
said: “We are very pleased with the recommendation by the DSMB, as
we seek to confirm whether remestemcel-L improves survival in
ventilated COVID-19 patients with moderate to severe ARDS. Patients
who have co-morbidities or are older are likely to continue to be
at high risk of ARDS and death,1-3 even if COVID-19 vaccines become
available. This is why having a potential treatment that reduces
mortality in these patients is so important.”
ARDS is the principal cause of death in COVID-19
infection and is thought to be due to a dysregulated immune
response in the lungs to COVID-19. Deaths continue to increase
in ventilator-dependent ARDS patients as COVID-19 cases continue to
surge globally. Despite improved treatment and earlier intervention
in hospitalized COVID-19 patients overall, the mortality rate in
COVID-19 ARDS patients who are over 60 years old remains more than
60%.1 These patients appear to be particularly refractory to
corticosteroids such as dexamethasone 4-5 and have not responded to
single cytokine antagonists, anti-virals, or anti-malaria
agents.
The Phase 3 trial aims to confirm findings from a
pilot study at New York’s Mt Sinai Hospital in March-April this
year where nine of 12 ventilator-dependent patients (75%) were
successfully discharged from hospital a median of 10 days after
receiving two intravenous doses of remestemcel-L within five days.
The ongoing Phase 3 trial, which is treating patients across more
than 20 hospitals in the United States, uses the same dosing
regimen.
Mesoblast holds an Investigational New Drug (IND)
submission for remestemcel-L in COVID-19 ARDS, with trial size,
protocol design, and endpoints developed with input from the United
States Food and Drug Administration. The third and final interim
analysis, when 60% of the randomized target has completed 30 days
of follow-up, will occur in the coming weeks.
References
- Mortality of COVID-19 Admitted Patients on Mechanical
Ventilators. Epic Health Research Network. June 26, 2020
- Harrison SL., et al. Comorbidities associated with mortality in
31,461 adults with COVID-19 in the United States: A federated
electronic medical record analysis. PLOS Medicine. September 10,
2020. https://doi.org/10.1371/journal.pmed.1003321
- Sanyaolu A., et al. Comorbidity and its Impact on Patients with
COVID-19. SN Compr Clin Med. 2020 Jun 25: 1-8.
doi: 10.1007/s42399-020-00363-4
- Dexamethasone in Hospitalized Patients with Covid-19 —
Preliminary Report. New England Journel of Medicine. July 17, 2020.
DOI: 10.1056/NEJMoa2021436
- Tomazini BM., et.al. Effect of Dexamethasone on Days Alive and
Ventilator-Free in Patients With Moderate or Severe Acute
Respiratory Distress Syndrome and COVID-19. JAMA
2020;324(13):1307-1316.
About Remestemcel-L Mesoblast’s
lead product candidate, remestemcel-L, is an investigational
therapy comprising culture-expanded mesenchymal stem cells derived
from the bone marrow of an unrelated donor. It is thought to have
immunomodulatory properties to counteract the cytokine storms that
are implicated in various inflammatory conditions by
down-regulating the production of pro-inflammatory cytokines,
increasing production of anti-inflammatory cytokines, and enabling
recruitment of naturally occurring anti-inflammatory cells to
involved tissues.
About Mesoblast Mesoblast Limited
(Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of commercial products and late-stage
product candidates. Mesoblast has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 in all major markets. The Company’s
proprietary manufacturing processes yield industrial-scale,
cryopreserved, off-the-shelf, cellular medicines. These cell
therapies, with defined pharmaceutical release criteria, are
planned to be readily available to patients worldwide.
Remestemcel-L is being developed for inflammatory
diseases in children and adults including steroid-refractory acute
graft versus host disease and moderate to severe acute respiratory
distress syndrome. Mesoblast is completing Phase 3 trials for its
product candidates for advanced heart failure and chronic low back
pain. Two products have been commercialized in Japan and Europe by
Mesoblast’s licensees, and the Company has established commercial
partnerships in Europe and China for certain Phase 3
assets.
Mesoblast has locations in Australia, the United
States and Singapore and is listed on the Australian Securities
Exchange (MSB) and on the Nasdaq (MESO). For more information,
please see www.mesoblast.com, LinkedIn: Mesoblast Limited and
Twitter: @Mesoblast
Forward-Looking Statements This
announcement includes forward-looking statements that relate to
future events or our future financial performance and involve known
and unknown risks, uncertainties and other factors that may cause
our actual results, levels of activity, performance or achievements
to differ materially from any future results, levels of activity,
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should not be read as a guarantee of future performance or results,
and actual results may differ from the results anticipated in these
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our forward-looking statements include, but are not limited to: the
timing, progress and results of Mesoblast’s preclinical and
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into, enroll and successfully complete, clinical studies; the
timing or likelihood of regulatory filings and approvals; and the
pricing and reimbursement of Mesoblast’s product candidates, if
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intellectual property on its product candidates and Mesoblast’s
ability to successfully defend these in cases of alleged
infringement. You should read this press release together with our
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our website. Uncertainties and risks that may cause Mesoblast’s
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statements, and accordingly, you should not place undue reliance on
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Release authorized by the Chief Executive.
For further information, please contact:
Media Julie Meldrum T: +61 3 9639 6036
E:julie.meldrum@mesoblast.com |
Kristen Bothwell T: +1 917 613 5434 E:kbothwell@rubenstein.com |
Investors Schond Greenway T: +212 880 2060
E: schond.greenway@mesoblast.com |
Paul Hughes
T: +61 3 9639 6036 E: paul.hughes@mesoblast.com |
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