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- Regdanvimab (CT-P59) (40mg/kg) has achieved statistically significant and clinically significant results in the four primary endpoints (including the primary endpoint and three key secondary endpoints); the company expects to release the complete results in the next few months Phase III data
- Regdanvimab (CT-P59) significantly reduces the risk of COVID-19-related hospitalization or death by 72% for high-risk patients who progress to severe COVID-19 and 70% of all patients
- Patients receiving regdanvimab (CT-P59) reported that for high-risk patients who progressed to severe COVID-19, the clinical recovery time was significantly reduced by at least 4.7 days, compared with placebo, the clinical recovery time for all patients was reduced by 4.9 days
- According to a recent article published by the Biochemical and Biophysical Research Newsletter, the clinical dose of Redavizumab (CT-P59) has proved sufficient for animals infected with the B.1.351 variant (now classified as Beta by the World Health Organization) Antiviral effect1
The Celltrion Group today announced the first-line efficacy and safety data of a global phase III clinical trial, proving that the anti-COVID-19 monoclonal antibody therapy candidate drug regdanvimab (CT-P59) has reached all primary and key secondary endpoints for mild patients—— To moderate COVID-19 symptoms (n=1,315).The results show that compared with placebo, CT-P59 can significantly reduce the risk of hospitalization or death of high-risk patients who progress to severe COVID-19 by 72% to the 28th day, reaching the primary efficacy endpoint [3.1 vs. 11.1 %, p-value< 0.0001]. CT-P59 also significantly reduced the risk of hospitalization or death by 70% of all patients, reaching the first key secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001].
The trial also reached other key secondary endpoints, including faster and longer-lasting reduction in symptom duration.Patients treated with CT-P59 (40mg/kg) recovered at least 4.7 days earlier than patients treated with placebo [median 9.3 vs. minimum 14 days, p-value< 0.0001] It is suitable for high-risk patients who develop severe COVID-19.For all patients treated with CT-P59 (40mg/kg), the patients recovered 4.9 days earlier than the placebo-treated patients [median 8.4 vs. 13.3 days, p-value< 0.0001].
The top-line results also showed that CT-P59 has positive safety characteristics, and there is no clinically significant difference between patients treated with CT-P59 (40mg/kg) and patients treated with placebo. Infusion-related reactions are mild and short-lived, and most patients recover within 1 to 3 days.
“We continue to be challenged by the COVID-19 pandemic and new variants,” said Dr. HoUng Kim, Head of Celltrion Healthcare’s medical and marketing department. “Due to COVID-19, many hospitals around the world are now beyond their capacity to accommodate patients, so we must take advantage of All resources to reduce the burden on the healthcare system. This well-controlled trial provides conclusive results that prove that CT-P59 can improve the prognosis of patients with mild to moderate COVID-19 and significantly reduce the risk of hospitalization and death. We I look forward to continuing to cooperate with regulatory agencies around the world so that more patients in need can use CT-P59.”
The therapeutic effect of CT-P59 on the B.1.351 variant (first discovered in South Africa and now classified as Beta by the World Health Organization) has been updated through the publication of the Biochemical and Biophysical Research Communications. According to this article, in vivo Ferret attack studies have shown that CT-P59 at a therapeutic dose can reduce the B.1.351 viral load of the upper and lower respiratory tracts, which is comparable to the observed wild-type virus.1
Celltrion plans to release complete Phase III data in the next few months, and plans to release it on 31stYingshi The European Conference on Clinical Microbiology and Infectious Diseases (ECCMID) will be held online from July 9-12, 2021.
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Note to editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to providing innovative and affordable medicines to facilitate patients’ access to advanced therapies. Its products are produced in the most advanced mammalian cell culture facilities, and its design and manufacturing comply with the US FDA cGMP and EU GMP guidelines. Celltrion Healthcare is committed to providing high-quality and cost-effective solutions through an extensive global network spanning more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.
About regdanvimab (CT-P59) and clinical trials
By screening candidate antibodies and selecting those that show the highest efficacy in neutralizing the SARS-CoV-2 virus, CT-P59 has been identified as a potential treatment for COVID-19. in vitro with in vivo Preclinical studies have shown that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralizes wild-type and interesting mutant variants including Alpha UK variant (B.1.17).in in vivo In the model, CT-P59 effectively reduced the viral load and lung inflammation of SARS-CoV-2. The results of global phase I and phase II clinical trials of CT-P59 show that it has good safety, tolerability, antiviral effects and efficacy characteristics in patients with mild to moderate symptoms of COVID-19.2 Celltrion has also recently begun to develop a neutralizing antibody mixture containing CT-P59 to combat the emerging variant of SARS-CoV-2. Celltrion’s clinical trial research was funded by the Korea Health Industry Development Institute (KHIDI) Korea Health Technology Research and Development Project funded by the Ministry of Health and Welfare of the Republic of Korea (funding number: HQ2xC00xx).
Forward-looking statement
Certain information listed in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare, which may constitute forward-looking statements under the relevant securities laws.
These statements can be identified by words such as “prepare”, “hope”, “coming”, “plan”, “aim”, “coming soon”, “being prepared”, “once obtained”, “may”, etc. “The purpose is”, “may”, “once determined”, “will”, “toward”, “expiry”, “become available”, “potential”, the negation of these words or other variants or similar the term.
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Forward-looking statements are provided to give potential investors an opportunity to understand management’s beliefs and opinions on the future so that they can use these beliefs and opinions as a factor in their investment evaluation. These statements are not guarantees of future performance and should not be overly relied on.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to be materially different from any future performance or result projections expressed or implied by such forward-looking statements.
Although the forward-looking statements contained in this presentation are based on reasonable assumptions deemed reasonable by the management of Celltrion/Celltrion Healthcare, there is no guarantee that the forward-looking statements will prove to be accurate because actual results and future events may differ from those anticipated in these statements. Except as required by applicable securities laws, Celltrion/Celltrion Healthcare assumes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions change. Readers are cautioned not to rely too much on forward-looking statements.
reference
1 Ryu DK., etc. The therapeutic effect of CT-P59 on SARS-CoV-2 South Africa 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 in the file
View the source version on businesswire.com: https://www.businesswire.com/news/home/20210614005275/en/
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