Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59
Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The global trial will evaluate the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection. Celltrion is set to obtain the summary of the primary results for Phase II of the study by the end of the year.
Celltrion has submitted the IND application for the clinical trial in 6 countries including Korea, the U.S and Spain, and plans to enrol more than 1,000 patients from up to 12 countries. The company expects to be able to apply for emergency use authorisation (EUA), conditional on the results of the pivotal trial.
Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate.
“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilise our response to the pandemic. The initiation of the global Phase II/III pivotal trial of CT-P59 is an important step forward, and together with the ongoing Phase I trial in patients with mild symptoms, Celltrion remains committed to investigating a potential anti-COVID-19 monoclonal antibody treatment,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion.
As part of its efforts to address the pandemic, Celltrion has also initiated an ongoing in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients, and plans to investigate the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients as part of a prevention clinical trial.
- 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
Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. 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.
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
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 neutralizing the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.4
1 Celltrion announces positive interim results from Phase I trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate [Press Release] Retrieved from https://www.businesswire.com/news/home/20200911005199/en/Celltrion-Announces-Positive-Interim-Results-Phase-Trial
2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: September 2020
3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: September 2020
4 Celltrion. Data on file
About Business Wire
(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
CureApp SC, Digital Therapeutic for Nicotine Addiction: Introducing a New Form of App-based Prescription Treatment - The Firs t Digital Therapeutic to Be Covered by Japan’s Public Healthcare Insurance System1.12.2020 07:36:00 CET | Press release
CureApp, Inc. (Headquarters: Chuo-ku, Tokyo; CEO: Kohta Satake) has announced that CureApp SC Nicotine Addiction Treatment App and CO Checker (hereafter, CureApp SC) – a treatment app (digital therapeutic) targeting nicotine addiction – is now covered by Japan’s public healthcare insurance system as of December 1, 2020, following a period of clinical trials and regulatory approval. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130006039/en/ CureApp SC, Digital Therapeutic for Nicotine Addiction Introducing a New Form of App-based Prescription Treatment The First Digital Therapeutic to be Covered by Japan’s Public Healthcare Insurance System (Photo: Business Wire) This marks the first case of a digital therapeutics application being covered by the insurance, as well as the first time that a digital therapeutic in the field of smoking cessation treatments has been covered by a country’s national health insurance system in
Ipsen Highlights New Strategic Priorities and Provides Mid-Term Financial Outlook1.12.2020 07:00:00 CET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a specialty-care focused biopharmaceutical group, today will host a virtual Capital Markets Day to highlight the Group’s new strategic priorities with the aim of driving continued growth and bringing transformative medicines to patients. David Loew, Chief Executive Officer of Ipsen stated: “Our new Group strategy positions Ipsen for long-term success by focusing together for patients and society. We will reinforce our commitment to Oncology, Rare Disease and Neuroscience by strengthening and accelerating our external innovation efforts and pipeline in clearly-defined segments. Through prioritization and collaboration, we will drive efficiencies to support investment in our pipeline. We are building on a strong foundation of engaged employees, agile development capabilities and global commercial footprint. I am energized to execute on our key strategic priorities to create long-term value for all stakeholders.” Bring the full potential
Process Sensing Technologies, a Battery Ventures Company, Announces New Majority Investment from AEA Investors1.12.2020 06:01:00 CET | Press release
Process Sensing Technologies (“PST”), a global manufacturer of instruments, analyzers and sensors for precision measurement and monitoring in a variety of critical industries, announced that global private-equity firm AEA Investors LP (“AEA”) has made a majority investment in the company. PST backer Battery Ventures will maintain a minority stake in the business. Baird acted as exclusive sell-side advisor; other terms of the transaction were not disclosed. PST—a platform constructed under Battery’s ownership comprising seven global businesses—sells its sensors and other technologies into industries including pharmaceuticals, life sciences, specialty gases, petrochemicals, food-and-beverage, semiconductors and building automation. The company’s products measure moisture, oxygen and pressure, among other things, and help improve customers’ profitability while helping them stay compliant with often-stringent industry regulations. Battery began the PST platform journey with its acquisition
Celltrion Completes Acquisition of Primary Care (PC) Product Assets for Asia Pacific Markets from Takeda Pharmaceutical Company Limited1.12.2020 00:00:00 CET | Press release
Celltrion (KRX:068270) has completed the acquisition of select primary care assets from Takeda Pharmaceutical Company Limited (“Takeda”) in Asia Pacific, igniting efforts to strengthen its R&D capability in the global small molecule pharmaceuticals business. In June, the firms announced an agreement under which Celltrion would acquire 18 "Primary Care" product assets in the Asia Pacific area for a total of USD 278 million inclusive of milestone payments from Takeda. Celltrion proceeded with the acquisition process through its newly established subsidiary in Singapore, "Celltrion Asia Pacific Pte, Ltd."1 ("Celltrion APAC"). Upon completion of the acquisition, Celltrion APAC will assume the ownership of the rights to patents, trademarks, and sales of 18 products sold in 9 markets including South Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. The 18 products include prescription medicines such as Nesina (diabetes), Actos (diabetes), and Eda
Takeda Completes Sale of Select OTC and Non-Core Assets to Celltrion in Asia Pacific1.12.2020 00:00:00 CET | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the completion of its previously-announced sale of a portfolio of select products to Celltrion Inc. (“Celltrion”) for a total value of $278 million USD inclusive of milestone payments. The portfolio includes 18 pharmaceutical products and over-the-counter (OTC) products sold in Asia Pacific, which is part of Takeda’s Growth & Emerging Markets Business Unit. This divestment agreement was first announced in June 2020. The divested portfolio includes pharmaceutical products and OTC products in the Cardiovascular, Diabetes and General Medicine therapeutic areas, sold in Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand. The products, while addressing key patient needs in these countries and territories, are outside of the business areas Takeda has chosen as core to its global long-term growth. As part of the deal, Takeda will continue to manufacture the portfol
Ipsen Receives FDA Fast Track Designation for Investigational Irinotecan Liposome Injection (ONIVYDE ® ) as a Second-Line Monotherapy Treatment for Small Cell Lung Cancer (SCLC)30.11.2020 22:58:00 CET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for irinotecan liposome injection (ONIVYDE®) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need. ONIVYDE® is currently approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. An ongoing Phase III randomized study (RESILIENT; NCT03088813) trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (ONIVYDE®) as a monotherapy for SCLC study patients who have progressed on or a