Business Wire

Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time

Share

Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models.

The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed.

Reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis were used to analyse specimens from the upper respiratory tract (nasal discharge and nasal turbinate) and the lungs. The samples from the high-dose group saw the viral load reduce by 100-fold. Furthermore, lung biopsy showed that both dosage groups saw inflammation returning to normal lung tissue histopathology within 6 days as well as a shortened recovery time, whereas the placebo-controlled group experienced sustained levels of lung inflammation and complications.

This announcement follows the identification of antibody candidates for an antiviral treatment which Celltrion completed in April. In response to these positive results, Celltrion will now conduct additional efficacy and toxicity testing in pre-clinical settings and anticipates starting first-in-human clinical trials in July.

“Celltrion is drawing on its expertise, innovation and previous experience in coronaviruses, such as efforts researching the efficacy of CT-P38, an investigational antibody to treat Middle East Respiratory Syndrome (MERS), as well as CT-P27, a multi-antibody drug for influenza which is being tested in a phase 2b study, to develop a safe and effective treatment for COVID-19,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “Celltrion is leveraging its advanced technologies to lead efforts to develop a novel antiviral antibody treatment containing potent therapeutic antibodies that can neutralise the virus. Celltrion hopes to commence first-in-human clinical trials in July and has the capability to roll out mass production of the therapeutic antibody treatment once it is ready.”

- ENDS -

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 COVID-191,2

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

There are currently no specific vaccines or treatments approved for COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

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 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: May 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: May 2020

Contact information

For further information please contact: 

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0) 7506 339043

Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Hilton Introduces Hilton EventReady with CleanStay, Setting New Standards for Event Cleanliness and Customer Service13.7.2020 06:01:00 CESTPress release

For more than 100 years, Hilton hotels around the world have set the stage for the world’s most coveted and important meetings, events and entertainment gatherings – from star-laden award shows and movie sets to energetic political conventions, global conferences and wow-worthy weddings. Today, that tradition continues – even at a safe distance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200712005004/en/ Hilton Introduces Hilton EventReady with CleanStay, Setting New Standards for Event Cleanliness and Customer Service. (Photo: Business Wire) To address safe group travel practices and evolve today’s event experience, Hilton today announced a global, industry-leading cleanliness and customer service program specific to meetings and events. Hilton EventReady with CleanStay is the next phase of the company’s recently launched Hilton CleanStay and was shaped by extensive research and feedback. “At Hilton, we’ve always believ

Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders12.7.2020 14:30:00 CESTPress release

Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502/NYSE:TAK) today announced that 13 abstracts are being presented from the company’s Hematology portfolio and pipeline at the International Society on Thrombosis and Haemostasis 2020 Virtual Congress (ISTH 2020). Among the data, Takeda spotlighted four abstracts to highlight its commitment to advancing personalized care through pharmacokinetic (PK)-guided prophylaxis in people living with hemophilia or von Willebrand Disease (VWD) – including scientific updates in patients with hemophilia A from the Phase 3 PROPEL and Phase 3b CONTINUATION studies investigating potential benefits of personalized TAK-660 (rurioctocog alfa pegol) prophylaxis. Two population studies into the PK/pharmacodynamic (PD) profiles of recombinant von Willebrand factor (rVWF), which provide data to assist in the optimization of rVWF personalized dosing strategies, were also presented. Takeda addresses the unique needs of each patient with personalized care

VR Fitness Developer FitXR Secures $7.5 Million In Series A Venture Round Led by Hiro Capital10.7.2020 08:00:00 CESTPress release

FitXR, the leading VR fitness company, today announces that it has secured $6.3m in investment funding, led by Hiro Capital, with continued support from U.S.-based BoostVC, Maveron and TenOneTen Ventures, together with an additional $1.2m in the form of an innovation loan, from Innovate UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005856/en/ Cherry Freeman, Co-Founding Partner, Hiro Capital (Photo: Business Wire) FitXR, who had previously secured $1.25 million in seed funding from investors, will use the new investment to expand its operations in Europe and North America, and to accelerate launch of several exciting new products and services for people to keep fit in Virtual Reality. The investment marks a significant show of belief in FitXR, who over the last year has grown to become one of the leaders of the VR fitness sector, with its mission to put the fun back into fitness. Its first product, the boxing rhyt

Laboratory Studies Confirm BETADINE® Antiseptic Products’ Effectiveness Against COVID-19 Virus10.7.2020 00:37:00 CESTPress release

Mundipharma today announced that laboratory testing at the Duke-NUS Medical School in Singapore, has confirmed the effectiveness of its BETADINE® antiseptic products against the novel coronavirus (SARS-CoV-2) which causes COVID-19 disease. Testing has demonstrated BETADINE’s® strong in-vitro virucidal activity, killing 99.99% of the SARS-CoV-2 virus in 30 seconds. The products subjected to testing were: BETADINE® antiseptic products, namely Solution (10% PVP-I), Skin Cleanser (7.5% PVP-I), Gargle and Mouthwash (1.0% PVP-I) and Throat Spray (0.45% PVP-I). The research has been published in the respected Infectious Disease and Therapy Journal on 08 July 2020. “These results confirm our view that BETADINE® antiseptic products, used appropriately and in conjunction with other preventative treatment options including PPE, can play a role in limiting the spread of infections, including COVID-19,” said Raman Singh, CEO Mundipharma. “It also provides the medical community as well as consumers

New Evidence Shows Morinaga Milk’s Probiotic Bifidobacterium breve A1 Improves Memory of Older Adults With Cognitive Dysfunction9.7.2020 20:00:00 CESTPress release

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company and a key global probiotics manufacturer, confirmed that its proprietary probiotic strain Bifidobacterium breve A1 (a.k.a. B. breve MCC1274) is safe and effective for improving memory functions of older adults with suspected mild cognitive impairment (MCI) in a randomized, double-blind, placebo-controlled trial (RCT). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005032/en/ Figure 1. Changes of RBANS scores at 16 weeks from baseline. Values are indicated as mean with error bars as the standard error. **p<0.001, ***p<0.0001, inter-group difference, Student’s t-test. (Graphic: Business Wire) The new study, published recently in the Journal of Alzheimer’s Disease, has produced breakthrough results uncovering a novel promising probiotic intervention for early dementia prevention. The clinical study conducted by a clinical research orga

rf IDEAS and Ricoh Simplify Secure Access to Multifunction Printers9.7.2020 18:05:00 CESTPress release

rf IDEAS, a leading manufacturer of credential readers for authentication and logical access, today announced with Ricoh the integration of its WAVE ID® Plus dual-frequency card reader technology with Ricoh’s Smart Operation Panel (SOP), Gen 2.5. The new WAVE ID Ricoh Universal SOP Reader is the most innovative reader for secure pull-print applications with Ricoh multifunction printers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005764/en/ WAVE ID® Ricoh Universal SOP Reader (Photo: Business Wire) rf IDEAS and Ricoh have a proven record of working together to deliver secure workplace solutions that feature the most advanced identification and authentication capabilities. “As we continue our worldwide partnership with a leader in the print industry, we are delighted that Ricoh chose rf IDEAS to develop an innovative credential reader design that connects to its A3 multifunction devices,” said Tod Besse, senior vice