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Regeneron has released preliminary descriptive data from its research new coronavirus neutral and antibody cocktail therapy REGEN-COV2 in a seamless Phase 1/2/3 clinical trial.
data show that REN-COV2 reduces viral load and reduces the time required for symptom relief when treating non-hospitalized COVID-19 patients.
reGEN-COV2 also showed a positive trend in reducing patient visits to hospitals.
reGEN-COV2 is a combination antibody therapy consisting of two monoclonal antibodies that target different clonals of the new coronavirus prickly protein.
it aims to alleviate COVID-19 symptoms by binding to the new coronavirus's prickly protein to prevent the new coronavirus from entering and infecting cells.
data released today from 275 non-hospitalized COVID-19 patients.
have all been tested for nucleic acids to confirm infection with the new coronavirus.
they were also tested for serological tests and measured viral load before being treated.
results showed that about 45 percent of patients were serologically positive, 41 percent were serologically negative, and 14 percent were classified as "other" because of unclear or unknown serological status.
patients were treated with a 1:1:1 ratio of one high dose of REGN-COV2 (8 mg), low dose of REGN-COV2 (2.4 mg) or a placebo.
study found that baseline serological status was much lower at baseline in serotonish-positive patients with a high correlation with baseline viral load (p.lt;0.0001), and that viral load quickly reached the lowest level of quantitative detection even without treatment.
, serologically negative patients had significantly higher levels of the virus at baseline and were slower to remove the virus without treatment. Serological status at
baseline can also predict the rate of remission of clinical symptoms of COVID-19 in patients treated with placebo, with the median symptom remission time in serologically positive patients being 7 days, while in serologically negative patients it was 13 days.
REGN-COV2 was more effective in serologically negative patients, with an average reduction of 0.60 log10 copies/ml of viral load in patients receiving high doses compared to the placebo group.
the low-dose treatment group was 0.51 log10 copies/ml (p-0.06).
in the general population, patients receiving high-dose treatment had a 0.51 log10 copy/ml reduction in viral load compared to placebo, compared to 0.23 log10 copy/ml in patients receiving low-dose treatment.
at the same time REN-COV2 shortens the time required for symptom relief in serologically negative patients, and 13 days, 8 days and 6 days for symptom relief in the placebo group, the high-dose group and the low-dose group.
baseline virus level, the better the REGN-COV2 effect, the higher the baseline virus level of patients after 7 days of treatment with REGN-COV2 virus load decreased significantly.
patients with a viral load of more than 10E5 copies per milliliter, the viral load was reduced by about 50-60% compared to a placebo.
patients with a viral load of more than 10E6 copies per milliliter, the viral load was reduced by about 95% compared to a placebo.
patients with a viral load of more than 10E7 copies per milliliter, the viral load was reduced by about 99% compared to a placebo. Dr. George D. Yancopoulos, President and Chief Scientific Officer of
Regeneration, said, "We are very pleased to see that the antibody cocktail therapy REGN-COV2 rapidly reduces viral load and associated symptoms in patients with COVID-19, and that those who do not have an effective immune response themselves benefit the most."
suggests that REN-COV2 can be an alternative to naturally occurring immune responses.
we are encouraged by these initial data, and we have begun to discuss our findings with regulators while continuing our ongoing clinical trials.
addition to being positive for REGN-COV2 clinical trials and other antibody therapies, these data also support the prospect of a vaccine targeting the new coronavirus prickly protein.
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