INCHEON, South Korea, Jan 4 (Bernama-BUSINESS WIRE) -- Celltrion
Group announced today results for its cocktail therapy candidates
including neutralisation data against the Omicron variant (B.1.1.529).
The
Phase I clinical trial is a randomised, double- blind and placebo-
controlled trial designed to evaluate the safety, tolerability and
pharmacokinetics of CT-P63 in 24 healthy subjects in Poland.
1 The
study met its primary objectives with data showing CT-P63 to be safe
and well tolerated, with no significant drug- related adverse events
(AEs).
In an experiment conducted in partnership with the
National Institutes of Health (NIH), CT-P63 showed strong neutralising
activity against the Omicron variant based on structural analysis by X-
ray crystallography and neutralisation data from pseudo- virus testing.
Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays
and animal model studies by the end of the first quarter this year.
In
order to elicit potent neutralising antibody response against the new
emerging variants, Celltrion previously identified a total of 38 potent
neutralising antibodies against SARS-CoV-2 in which antibody candidate
No. 32 (CT-P63) produced high neutralisation titres against new emerging
strains. CT-P63 has previously been demonstrated to have neutralising
activity against the most common variants, including the Alpha, Beta,
Gamma and Delta variants.
“The positive results demonstrate the
potential of our cocktail therapy to retain neutralising ability against
the Omicron variant” said Dr. HoUng Kim, Ph.D., Head of Medical and
Marketing Division at Celltrion Healthcare. “We are confident that our
antibody platform including Regkirona and CT-P63 will provide
significant benefit for patients with COVID-19. Regkirona is given to a
patient intravenously, so the drug could effectively treat patients
hospitalised with COVID-19 at an early stage, while the nebulised
cocktail therapy could address patients’ unmet needs for at- home
treatment. We plan to discuss large- scale clinical trial for our
nebulised cocktail therapy (CT-P63 in combination with Regkirona™) with
regulatory agencies worldwide in the near future.”
-
ENDS -Notes to Editors:About Celltrion HealthcareCelltrion
Healthcare is committed to delivering innovative and affordable
medications to promote patients’ access to advanced therapies. Its
products are manufactured at state-of-the-art mammalian cell culture
facilities, designed and built to comply with the US FDA cGMP and the EU
GMP guidelines. Celltrion Healthcare endeavours to offer high-quality
cost-effective solutions through an extensive global network that spans
more than 110 different countries. For more information please visit:
https://www.celltrionhealthcare.com/en-us.
About regdanvimab (CT-P59)CT-P59
was identified as a potential treatment for COVID-19 through screening
of antibody candidates and selecting those that showed the highest
potency in neutralising the SARS-CoV-2 virus.
In vitro and
in vivo pre-
clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD
and significantly neutralises the wild type and mutant variants of
concern. In
in vivo models, CT-P59 effectively reduced the
viral load of SARS-CoV-2 and inflammation in lung. Results from the
global phase I and phase II/III clinical trials of CT-P59 demonstrated a
promising safety, tolerability, antiviral effect and efficacy profile
in patients with mild-to-moderate symptoms of COVID-19.
2 The
EC granted marketing authorisation for Celltrion’s regdanvimab following
positive opinion by the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) in November 2021.
About CT-P63CT-P63
is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding
domain (RBD) as a treatment for COVID-19 infection. CT-P63 is currently
being developed as a potential treatment for SARS-CoV-2 infection.
About nebulised formulationThe
nebulised formulation of the monoclonal antibody not only targets
SARS-CoV-2 spike receptor binding domain (RBD) and elicit neutralising
antibody response but it also has ‘trapping’ mechanism of action and
thereby neutralises and traps in mucus with exceptional potency. The
muco-trapping antibody platform directly traps the virus in airway
mucus, preventing the local spread of the infection, and quickly
eliminating the virus from the lungs through the body's natural ability
to clear mucus. Nebulized formulation can be readily self-administered
by patients, extend critical drug supplies to more patients by reducing
the dosage needed, and does not place excessive demands on healthcare
staff and infusion clinic space that intravenous (IV) drugs do.
FORWARD LOOKING STATEMENTCertain
information set forth in this press release contains statements related
to our future business and financial performance and future events or
developments involving Celltrion/Celltrion Healthcare that may
constitute forward-looking statements, under pertinent securities laws.
These
statements may be identified by words such as “prepares”, “hopes to”,
“upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing,
“once gained”, “could”, “with the aim of”, “may”, “once identified”,
“will”, “working towards”, “is due”, “become available”, “has potential
to”, the negative of these words or such other variations thereon or
comparable terminology.
In addition, our representatives may make
oral forward-looking statements. Such statements are based on the
current expectations and certain assumptions of Celltrion/Celltrion
Healthcare's management, of which many are beyond its control.
Forward-looking
statements are provided to allow potential investors the opportunity to
understand management’s beliefs and opinions in respect of the future
so that they may use such beliefs and opinions as one factor in
evaluating an investment. These statements are not guarantees of future
performance and undue reliance should not be placed on them.
Such
forward-looking statements necessarily involve known and unknown risks
and uncertainties, which may cause actual performance and financial
results in future periods to differ materially from any projections of
future performance or result expressed or implied by such
forward-looking statements.
Although forward-looking statements
contained in this presentation are based upon what management of
Celltrion/Celltrion Healthcare believes are reasonable assumptions,
there can be no assurance that forward-looking statements will prove to
be accurate, as actual results and future events could differ materially
from those anticipated in such statements. Celltrion/Celltrion
Healthcare undertakes no obligation to update forward-looking statements
if circumstances or management’s estimates or opinions should change
except as required by applicable securities laws. The reader is
cautioned not to place undue reliance on forward-looking statements.
References____________________________
1 ClinicalTrials.gov. To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects. Available at:
https://clinicaltrials.gov/ct2/show/NCT05017168#wrapper [Last Accessed January 2022]
2 Celltrion Data on file
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https://www.businesswire.com/news/home/20220102005042/en/ContactHolly Barber
hbarber@hanovercomms.com +44 (0) 07759 301620
Donna Curran
dcurran@hanovercomms.com+44 (0) 7984 550312
Source : Celltrion Healthcare 
