Added: Rober Pickney - Date: 01.05.2022 16:22 - Views: 43143 - Clicks: 8973
Greatest improvements in patients who had not mounted their own effective immune response prior to treatment. Regeneron to host investor and media webcast to discuss at pm ET today. Regeneron Pharmaceuticals, Inc. The ongoing, randomized, double-blind trial measures the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care. Yancopoulos , M. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms.
We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials. The descriptive analysis included the first patients enrolled in the trial and was deed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment; the next cohort, which could be used to rapidly and prospectively confirm these , has already been enrolled.
All patients entering the trial had laboratory-confirmed COVID that was being treated in the outpatient setting. Patients were prospectively characterized prior to treatment by serology tests to see if they had already generated antiviral antibodies on their own and were classified as seronegative no measurable antiviral antibodies or seropositive measurable antiviral antibodies. Key data findings include: Note that since this analysis was considered descriptive, all p-values are nominal. On average, patients were 44 years of age.
Patients will be followed for 29 days, with viral shedding in the upper respiratory tract assessed approximately every days in the Phase 2 portion of the trial and clinical endpoints assessed via investigator and patient-reported data throughout. Recruitment in all 4 trials is ongoing. To access the call, dial U. A link to the webcast may be accessed from the "Investors and Media" of Regeneron's website at www. A replay of the conference call and webcast will be archived on the Company's website and will be available for at least 30 days. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are deed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases. For additional information about the company, please visit www. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc.
Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Attorney's Office for the District of Massachusetts , the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating , and financial condition.
A more complete description of these and other material risks can be found in Regeneron's filings with the U. Securities and Exchange Commission, including its Form Q for the quarterly period ended June 30, Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly or otherwise any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Seropositive patients had much lower levels of virus at baseline, and rapidly achieved viral lo approaching lowest levels quantifiable LLQ , even without treatment. In contrast, seronegative patients had substantially higher viral levels at baseline, and cleared virus more slowly in the absence of treatment. Serological status at baseline also predicted how rapidly patients had alleviation of their COVID clinical symptoms. In the untreated placebo patients, seropositive patients had a median time to alleviation of symptoms of 7 days, compared to seronegative patients who had a median time to alleviation of symptoms of 13 days.
The mean time-weighted-average change from baseline nasopharyngeal NP viral load through Day 7 in the seronegative group was a 0. In the overall population, there was a 0. Patients with increasing viral lo at baseline had correspondingly increasing benefit in time to symptom alleviation. There were a small of medically-attended visits given that most non-hospitalized patients recover well at home.
Patients in the seronegative group were at higher risk of medically-attended visits: 10 of the 12 medically-attended visits defined as hospitalizations, or emergency room, urgent care or telemedicine visits for COVID occurred in patients who were seronegative at baseline. In the seronegative group, Both doses were well-tolerated.
Serious adverse events occurred in 2 placebo patients, 1 low dose patient and no high dose patients. There were no deaths in the trial.Looking to release this load
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