Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment

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INCHEON, South Korea — Celltrion Group at present introduced top-line efficacy and security information from the worldwide Part III medical trial, demonstrating that anti-COVID-19 monoclonal antibody therapy candidate, regdanvimab (CT-P59), met all major and key secondary endpoints in sufferers with mild- to- reasonable signs of COVID-19 (n=1,315). Outcomes confirmed that CT-P59 considerably lowered the danger of hospitalisation or loss of life by 72% for sufferers at high- threat of progressing to extreme COVID-19 as much as Day 28, in comparison with placebo, assembly the first efficacy endpoint [3.1 vs. 11.1 %, p-value< 0.0001]. CT-P59 additionally considerably lowered the danger of hospitalisation or loss of life by 70% in all sufferers, assembly the primary key secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001].

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The trial additionally met the opposite key secondary endpoints, together with sooner and chronic discount in symptom period. Sufferers handled with CT-P59 (40mg/kg) recovered a minimum of 4.7 days sooner than these within the placebo-treated sufferers [median 9.3 vs. minimum 14 days, p-value< 0.0001] for sufferers at high- threat of progressing to extreme COVID-19. For all sufferers handled with CT-P59 (40mg/kg), sufferers recovered 4.9 days sooner than these within the placebo-treated sufferers [median 8.4 vs. 13.3 days, p-value< 0.0001].

High-line outcomes additionally confirmed CT-P59 to have a optimistic security profile, with no clinically significant variations between sufferers handled with CT-P59 (40mg/kg) and placebo-treated sufferers. Infusion associated reactions had been gentle and transient, with most sufferers recovering inside 1~3 days.

“We proceed to be challenged by the COVID-19 pandemic and new variants of concern,” stated Dr. HoUng Kim, Ph.D., Head of Medical and Advertising Division at Celltrion Healthcare. “As many hospitals throughout the globe now exceed their means to accommodate sufferers on account of COVID-19, it’s vital that we use each useful resource to scale back the burden on the healthcare system. This well-controlled trial supplies conclusive outcomes demonstrating that CT-P59 can enhance outcomes in individuals with mild- to- reasonable COVID-19 and in addition considerably cut back the danger of hospitalisation and loss of life. We stay up for persevering with to work with regulators around the globe to make CT-P59 out there to extra sufferers in want.”

Therapeutic impact of CT-P59 towards B.1.351 variant (first recognized in South Africa, now categorized by the WHO as Beta) was up to date via the publication from Biochemical and Biophysical Analysis Communications. In accordance with the article, in vivo ferret problem research demonstrated {that a} therapeutic dosage of CT-P59 was in a position to lower B.1.351 viral load within the higher and decrease respiratory tracts, corresponding to that noticed for the wild kind virus.¹

Celltrion plans to launch full Part III information within the coming months and plans to current the information at an oral session on the 31^st European Congress of Medical Microbiology & Infectious Ailments (ECCMID), which is able to happen on-line from 9 -12 July 2021.

–ENDS –

Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is dedicated to delivering progressive and reasonably priced medicines to advertise sufferers’ entry to superior therapies. Its merchandise are manufactured at state-of-the-art mammalian cell tradition services, designed and constructed to adjust to the US FDA cGMP and the EU GMP pointers. Celltrion Healthcare endeavours to supply high-quality cost-effective options via an intensive world community that spans greater than 110 completely different nations. For extra data please go to: https://www.celltrionhealthcare.com/en-us.

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About regdanvimab (CT-P59) and medical trials

CT-P59 was recognized as a possible therapy for COVID-19 via screening of antibody candidates and choosing those who confirmed the best efficiency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre-clinical research confirmed that CT-P59 strongly binds to SARS-CoV-2 RBD and considerably neutralise the wild kind and mutant variants of concern together with the Alpha UK variant (B.1.17). In in vivo fashions, CT-P59 successfully lowered the viral load of SARS-CoV-2 and irritation in lung. Outcomes from the worldwide Part I and II medical trials of CT-P59 demonstrated a promising security, tolerability, antiviral impact and efficacy profile in sufferers with mild- to- reasonable signs of COVID-19.² Celltrion additionally has not too long ago commenced the event of a neutralising antibody cocktail with CT-P59 towards new rising variants of SARS-CoV-2. The analysis for Celltrion’s medical trials was supported by a grant as a part of the Korea Well being Expertise R&D Undertaking from the Korea Well being Trade Improvement Institute (KHIDI), funded by the ministry of Well being & Welfare, Republic of Korea (grant quantity: HQ2xC00xx).

FORWARD LOOKING STATEMENT

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Such forward-looking statements essentially contain recognized and unknown dangers and uncertainties, which can trigger precise efficiency and monetary ends in future durations to vary materially from any projections of future efficiency or consequence expressed or implied by such forward-looking statements.

Though forward-looking statements contained on this presentation are based mostly upon what administration of Celltrion/Celltrion Healthcare believes are affordable assumptions, there may be no assurance that forward-looking statements will show to be correct, as precise outcomes and future occasions might differ materially from these anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to replace forward-looking statements if circumstances or administration’s estimates or opinions ought to change besides as required by relevant securities legal guidelines. The reader is cautioned to not place undue reliance on forward-looking statements.

References

¹ Ryu DK., et al. Therapeutic impact of CT-P59 towards SARS-CoV-2 South African variant. Biochemical and Biophysical Analysis Communications, Quantity 566, 2021, Pages 135-140, https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed June 2021]

² Celltrion Information on file

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