INCHEON, South Korea-Tuesday 22 June 2021 [ AETOS Wire ]
Regdanvimab
(CT-P59) (40mg/kg) achieved statistically significant and clinically
meaningful results in four main endpoints including primary and three
key secondary endpoints; the company anticipates full Phase III data to
be released in the coming months
Regdanvimab (CT-P59) significantly
reduced the risk of COVID-19 related hospitalisation or death by 72% for
patients at high- risk of progressing to severe COVID-19 and 70% for
all patients
Patients who were treated with regdanvimab (CT-P59)
reported a significantly shortened time to clinical recovery by at least
4.7 days quicker for patients at high- risk of progressing to severe
COVID-19 and by 4.9 days quicker compared to placebo for all patients
According
to the recently published article from Biochemical and Biophysical
Research Communications, sufficient antiviral effect in B.1.351 variant
(now classified by the WHO as Beta)-infected animals was confirmed with a
clinical dosage of regdanvimab (CT-P59)1
(BUSINESS WIRE) --
Celltrion Group today announced top-line efficacy and safety data from
the global Phase III clinical trial, demonstrating that anti-COVID-19
monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all
primary and key secondary endpoints in patients with mild- to- moderate
symptoms of COVID-19 (n=1,315). Results showed that CT-P59 significantly
reduced the risk of hospitalisation or death by 72% for patients at
high- risk of progressing to severe COVID-19 up to Day 28, compared to
placebo, meeting the primary efficacy endpoint [3.1 vs. 11.1 %,
p-value< 0.0001]. CT-P59 also significantly reduced the risk of
hospitalisation or death by 70% in all patients, meeting the first key
secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001].
The trial
also met the other key secondary endpoints, including faster and
persistent reduction in symptom duration. Patients treated with CT-P59
(40mg/kg) recovered at least 4.7 days earlier than those in the
placebo-treated patients [median 9.3 vs. minimum 14 days, p-value<
0.0001] for patients at high- risk of progressing to severe COVID-19.
For all patients treated with CT-P59 (40mg/kg), patients recovered 4.9
days earlier than those in the placebo-treated patients [median 8.4 vs.
13.3 days, p-value< 0.0001].
Top-line results also showed
CT-P59 to have a positive safety profile, with no clinically meaningful
differences between patients treated with CT-P59 (40mg/kg) and
placebo-treated patients. Infusion related reactions were mild and
transient, with most patients recovering within 1~3 days.
“We
continue to be challenged by the COVID-19 pandemic and new variants of
concern,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing
Division at Celltrion Healthcare. “As many hospitals across the globe
now exceed their ability to accommodate patients due to COVID-19, it is
critical that we use every resource to reduce the burden on the
healthcare system. This well-controlled trial provides conclusive
results demonstrating that CT-P59 can improve outcomes in people with
mild- to- moderate COVID-19 and also significantly reduce the risk of
hospitalisation and death. We look forward to continuing to work with
regulators around the world to make CT-P59 available to more patients in
need.”
Therapeutic effect of CT-P59 against B.1.351 variant
(first identified in South Africa, now classified by the WHO as Beta)
was updated through the publication from Biochemical and Biophysical
Research Communications. According to the article, in vivo ferret
challenge studies demonstrated that a therapeutic dosage of CT-P59 was
able to decrease B.1.351 viral load in the upper and lower respiratory
tracts, comparable to that observed for the wild type virus.1
Celltrion
plans to release full Phase III data in the coming months and plans to
present the data at an oral session at the 31st European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID), which will
take place online from 9 -12 July 2021.
Notes to Editors:
About Celltrion Healthcare
Celltrion
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) and clinical trials
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 neutralise the wild type and mutant variants of
concern including the Alpha UK variant (B.1.17). 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 II 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 Celltrion also has recently commenced the development of a
neutralising antibody cocktail with CT-P59 against new emerging variants
of SARS-CoV-2. The research for Celltrion’s clinical trials was
supported by a grant as part of the Korea Health Technology R&D
Project from the Korea Health Industry Development Institute (KHIDI),
funded by the ministry of Health & Welfare, Republic of Korea (grant
number: HQ2xC00xx).
FORWARD LOOKING STATEMENT
Certain
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
Ryu DK., et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South
African variant. Biochemical and Biophysical Research Communications,
Volume 566, 2021, Pages 135-140,
https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed June 2021]
2 Celltrion Data on file
View source version on businesswire.com: https://www.businesswire.com/news/home/20210614005275/en/
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