TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ —
Second Part Three trial undertaken in collaboration with NIAID to announce outcomes at the moment, each utilizing subcutaneous administration of REGEN-COV in asymptomatic people with out prior COVID-19 an infection
Regeneron Prescribed drugs, Inc. (NASDAQ: REGN) at the moment introduced optimistic information from a Part Three trial (2069B) of lately contaminated asymptomatic COVID-19 sufferers, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered through subcutaneous (SC) administration. REGEN-COV diminished the general threat of progressing to symptomatic COVID-19 by 31% (major endpoint), and by 76% after the third day. The trial additionally demonstrated that REGEN-COV shortened symptom length and markedly diminished viral ranges.
The Part Three trial is the second to report outcomes at the moment, which was collectively run with the Nationwide Institute of Allergy and Infectious Ailments (NIAID), a part of the Nationwide Institutes of Well being (NIH). The trial enrolled 204 people with none COVID-19 signs who examined optimistic for SARS-CoV-2 however didn’t have anti-virus antibodies at baseline, and have been randomized to obtain both 1 dose of REGEN-COV (1,200 mg) or placebo.
“COVID-19 transmission usually happens through contaminated individuals who don’t but have signs, so it’s crucial that we quickly diagnose and deal with these people for their very own well being and to forestall transmission,” mentioned Katharine Bar, M.D., co-principal investigator of the trial and Assistant Professor of Medication, Infectious Ailments, Hospital of the College of Pennsylvania. “These information pave the best way for REGEN-COV for use earlier than sufferers change into symptomatic, with a extra handy subcutaneous administration.”
The trial met all major and key secondary endpoints. Along with lowering the chance of symptomatic infections, the entire variety of weeks sufferers skilled signs was almost lower in half (45%) with REGEN-COV, and the viral burden was diminished by greater than 90%. Whereas not included within the preliminary evaluation plan, researchers additionally discovered that Zero REGEN-COV sufferers and 6 placebo sufferers have been both hospitalized or visited the emergency room due to COVID-19 through the 29-day efficacy evaluation interval.
The info construct on beforehand introduced outcomes from the Part Three outcomes (2067) and Part 2 virology (20145) trials in non-hospitalized COVID-19 sufferers. The Part Three outcomes trial in high-risk symptomatic outpatients confirmed that REGEN-COV (2,400 mg and 1,200 mg administered intravenously [IV]) diminished hospitalization or demise by 70%. The Part 2 virology trial in low-risk outpatients confirmed that every one REGEN-COV doses studied had comparable efficacy in quickly lowering viral load (IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600 mg).
“These Part Three information present much more proof that REGEN-COV, this time given to asymptomatic sufferers through handy injections, can change the course of COVID-19 an infection in non-hospitalized sufferers,” mentioned George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “On this trial, the REGEN-COV antibody cocktail successfully prevented asymptomatic sufferers from changing into symptomatic, and quickly lowered their viral load.”
TABLE: Key Outcomes from Part Three Therapy Trial in
Asymptomatic Contaminated Individuals1
(single 1,200 mg dose)
Threat of symptomatic SARS-CoV-2 an infection
Total threat discount by way of day 29 (major endpoint)
# of sufferers with occasions
Total threat discount after day 3 (days 4-29)2,3
# of sufferers with occasions
Signs, viral load and COVID-19 associated occasions
Complete weeks with signs
Complete # of weeks (cumulative for all sufferers in every arm)
Complete weeks with excessive viral load (>104 copies/mL)
Complete # of weeks (cumulative for all sufferers in every arm)
COVID-19 associated hospitalizations or emergency room (ER) visits3
# of sufferers with occasions
Primarily based on the seronegative modified Full Evaluation Set inhabitants, which incorporates all randomized asymptomatic sufferers who have been SARS-CoV-2 optimistic however had no proof of prior an infection (i.e., a optimistic RT-qPCR take a look at and a unfavorable antibody take a look at) at randomization
Doesn’t embrace outcomes from days 1-3, when occasions have been comparable between remedy teams
These analyses weren’t a part of the pre-planned statistical evaluation plan, so p-values are nominal
Adversarial occasions (AEs) occurred in 34% (n=52 out of 155) of REGEN-COV sufferers and 48% (n=75 out of 156) of placebo sufferers, and severe AEs occurred in 0% (n=0) of REGEN-COV and three% (n=4) of placebo sufferers. Injection web site reactions, all of which have been grades 1-2, occurred in 4% (n=6) of REGEN-COV and 1% (n=1) of placebo sufferers. No sufferers from both group withdrew from the trial attributable to AEs, and there have been no deaths.
REGEN-COV continues to be evaluated in scientific trials in a number of settings for COVID-19: for the prevention of COVID-19 in family contacts of contaminated people, and in non-hospitalized and sure hospitalized sufferers, together with the open-label RECOVERY trial of hospitalized sufferers within the UK. As of April 2021, greater than 25,000 individuals have participated in scientific trials involving REGEN-COV.
The event and manufacturing of REGEN-COV have been funded partly with federal funds from the Biomedical Superior Analysis and Growth Authority (BARDA), a part of the U.S. Division of Well being and Human Providers, Workplace of the Assistant Secretary for Preparedness and Response, below OT quantity: HHSO100201700020C.
Concerning the Multi-part Part 3 Trial
To qualify for the joint Regeneron/NIAID multi-part Part Three trial, all contributors have been enrolled with none COVID-19 signs (asymptomatic) and lived in the identical family as a person who examined optimistic for SARS-CoV-2 throughout the prior Four days. All contributors have been examined for SARS-CoV-2 at baseline utilizing a RT-qPCR take a look at from nasopharyngeal swabs. Members with a unfavorable take a look at consequence joined the prevention trial (2069A) and contributors with a optimistic take a look at consequence joined the remedy trial (2069B).
All contributors have been then randomized (1:1) to obtain both 1 dose of REGEN-COV (1,200 mg) or placebo, administered through Four SC injections.
Amongst contributors enrolled within the remedy trial, 35% have been Latino/Hispanic and 5% have been Black/African American. In complete, 32% had at the very least 1 identified issue that put them at excessive threat of struggling extreme penalties from COVID-19, as outlined within the REGEN-COV truth sheet. As well as, 32% have been overweight and 34% have been aged ³50 years (median age: 41 years; vary: 12-87 years).
Concerning the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also called REGN10933 and REGN10987) that was designed particularly to dam infectivity of SARS-CoV-2, the virus that causes COVID-19, utilizing Regeneron’s proprietary VelocImmune® and VelociSuite® applied sciences. The 2 potent, virus-neutralizing antibodies that kind the cocktail bind non-competitively to the crucial receptor binding area of the virus’s spike protein, which diminishes the flexibility of mutant viruses to flee remedy and protects in opposition to spike variants which have arisen within the human inhabitants, as detailed in Science.
Underneath an EUA issued by the U.S. Meals and Drug Administration (FDA), REGEN-COV is at the moment obtainable within the U.S. to deal with mild-to-moderate COVID-19 in adults, in addition to in pediatric sufferers at the very least 12 years of age and weighing at the very least 40 kg, who’ve acquired optimistic outcomes of direct SARS-CoV-2 viral testing and are at excessive threat for progressing to extreme COVID-19 and/or hospitalization. REGEN-COV has not been authorised by the FDA however has been licensed for emergency use. This use is permitted solely in the course of the declaration that circumstances exist justifying the authorization of the emergency use below part 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), until the authorization is terminated or revoked sooner.
REGEN-COV is at the moment licensed and obtainable in a 2,400 mg IV dose, with infusion instances as brief as 20 minutes. The factors for ‘high-risk’ sufferers are described within the Reality Sheet for Healthcare Suppliers. Within the U.S., REGEN-COV is just not licensed to be used in sufferers who’re hospitalized attributable to COVID-19 or require oxygen remedy, or for individuals at the moment utilizing continual oxygen remedy due to an underlying comorbidity who require a rise in baseline oxygen stream charge attributable to COVID-19.
Underneath this EUA, REGEN-COV is out there all through the U.S. – data on availability in your space is out there from the Division of Well being and Human Providers and the Nationwide Infusion Middle Affiliation.
Regeneron is collaborating with Roche to extend international provide of REGEN-COV. Regeneron is answerable for improvement and distribution of the remedy within the U.S., and Roche is primarily answerable for improvement and distribution outdoors the U.S. The businesses share a dedication to creating the antibody cocktail obtainable to COVID-19 sufferers across the globe and can help entry in low- and lower-middle-income nations by way of drug donations to be made in partnership with public well being organizations.
About Regeneron’s VelocImmune Expertise
Regeneron’s VelocImmune expertise makes use of a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to supply optimized absolutely human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate pupil along with his mentor Frederick W. Alt in 1985, they have been the primary to envision making such a genetically humanized mouse, and Regeneron has spent many years inventing and creating VelocImmune and associated VelociSuite applied sciences. Dr. Yancopoulos and his workforce have used VelocImmune expertise to create roughly 1 / 4 of all unique, FDA-approved absolutely human monoclonal antibodies at the moment obtainable. This contains REGEN-COVTM (casirivimab with imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents life-transforming medicines for individuals with severe ailments. Based and led for over 30 years by physician-scientists, our distinctive capability to repeatedly and constantly translate science into drugs has led to 9 FDA-approved remedies and quite a few product candidates in improvement, nearly all of which have been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye ailments, allergic and inflammatory ailments, most cancers, cardiovascular and metabolic ailments, ache, hematology, infectious ailments and uncommon ailments.
Regeneron is accelerating and bettering the standard drug improvement course of by way of our proprietary VelociSuite applied sciences, similar to VelocImmune, which makes use of distinctive genetically humanized mice to supply optimized absolutely human antibodies and bispecific antibodies, and thru bold analysis initiatives such because the Regeneron Genetics Middle, which is conducting one of many largest genetics sequencing efforts on the planet. For extra details about the corporate, please go to or observe @Regeneron on Twitter.
Ahead-Trying Statements and Use of Digital Media
This press launch contains forward-looking statements that contain dangers and uncertainties regarding future occasions and the longer term efficiency of Regeneron Prescribed drugs, Inc. (“Regeneron” or the “Firm”), and precise occasions or outcomes might differ materially from these forward-looking statements. Phrases similar to “anticipate,” “anticipate,” “intend,” “plan,” “consider,” “search,” “estimate,” variations of such phrases, and comparable expressions are meant to determine such forward-looking statements, though not all forward-looking statements include these figuring out phrases. These statements concern, and these dangers and uncertainties embrace, amongst others, the impression of SARS-CoV-2 (the virus that has induced the COVID-19 pandemic) on Regeneron’s enterprise and its workers, collaborators, and suppliers and different third events on which Regeneron depends, Regeneron’s and its collaborators’ capability to proceed to conduct analysis and scientific applications, Regeneron’s capability to handle its provide chain, web product gross sales of merchandise marketed or in any other case commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Merchandise”), and the worldwide financial system; the character, timing, and attainable success and therapeutic functions of Regeneron’s Merchandise and product candidates and analysis and scientific applications now underway or deliberate, together with with out limitation the event program regarding REGEN-COVTM (casirivimab with imdevimab) antibody cocktail; how lengthy the Emergency Use Authorization (“EUA”) granted by the U.S. Meals and Drug Administration (the “FDA”) for REGEN-COV will stay in impact and whether or not the EUA is revoked by the FDA based mostly on its willpower that the underlying well being emergency now not exists or warrants such authorization or different causes; the probability, timing, and scope of attainable regulatory approval and industrial launch of Regeneron’s product candidates (similar to REGEN-COV) and new indications for Regeneron’s Merchandise; whether or not the 1,200 mg subcutaneous dose of REGEN-COV shall be included within the EUA for REGEN-COV based mostly on the information mentioned on this press launch or in any other case; the flexibility of Regeneron’s collaborators, suppliers, or different third events (as relevant) to carry out manufacturing, filling, ending, packaging, labeling, distribution, and different steps associated to Regeneron’s Merchandise and product candidates (together with REGEN-COV) and the impression of the foregoing on Regeneron’s capability to provide its Merchandise and product candidates (together with REGEN-COV); the flexibility of Regeneron to handle provide chains for a number of merchandise and product candidates; issues of safety ensuing from the administration of Regeneron’s Merchandise and product candidates (similar to REGEN-COV) in sufferers, together with severe issues or uncomfortable side effects in reference to the usage of Regeneron’s Merchandise and product candidates in scientific trials; uncertainty of market acceptance and industrial success of Regeneron’s Merchandise and product candidates and the impression of research (whether or not carried out by Regeneron or others and whether or not mandated or voluntary) (together with the examine mentioned on this press launch) on any potential regulatory approval (together with with respect to REGEN-COV) and/or the industrial success of Regeneron’s Merchandise and product candidates; determinations by regulatory and administrative governmental authorities which can delay or limit Regeneron’s capability to proceed to develop or commercialize Regeneron’s Merchandise and product candidates, together with with out limitation REGEN-COV; ongoing regulatory obligations and oversight impacting Regeneron’s Merchandise, analysis and scientific applications, and enterprise, together with these regarding affected person privateness; the provision and extent of reimbursement of Regeneron’s Merchandise from third-party payers, together with non-public payer healthcare and insurance coverage applications, well being upkeep organizations, pharmacy profit administration corporations, and authorities applications similar to Medicare and Medicaid; protection and reimbursement determinations by such payers and new insurance policies and procedures adopted by such payers; competing medication and product candidates that could be superior to, or more economical than, Regeneron’s Merchandise and product candidates; the extent to which the outcomes from the analysis and improvement applications carried out by Regeneron and/or its collaborators could also be replicated in different research and/or result in development of product candidates to scientific trials, therapeutic functions, or regulatory approval; unanticipated bills; the prices of creating, producing, and promoting merchandise; the flexibility of Regeneron to satisfy any of its monetary projections or steerage and adjustments to the assumptions underlying these projections or steerage; the potential for any license, collaboration, or provide settlement, together with Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated corporations, as relevant), in addition to Regeneron’s collaboration with Roche regarding REGEN-COV, to be cancelled or terminated; and dangers related to mental property of different events and pending or future litigation relating thereto (together with with out limitation the patent litigation and different associated proceedings regarding EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Praluent® (alirocumab), and REGEN-COV), different litigation and different proceedings and authorities investigations regarding the Firm and/or its operations, the last word consequence of any such proceedings and investigations, and the impression any of the foregoing might have on Regeneron’s enterprise, prospects, working outcomes, and monetary situation. A extra full description of those and different materials dangers could be present in Regeneron’s filings with the U.S. Securities and Alternate Fee, together with its Type 10-Okay for the 12 months ended December 31, 2020. Any forward-looking statements are made based mostly on administration’s present beliefs and judgment, and the reader is cautioned to not depend on any forward-looking statements made by Regeneron. Regeneron doesn’t undertake any obligation to replace (publicly or in any other case) any forward-looking assertion, together with with out limitation any monetary projection or steerage, whether or not because of new data, future occasions, or in any other case.
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SOURCE Regeneron Prescribed drugs, Inc.
Posted: April 2021
REGEN-COV (casirivimab and imdevimab) FDA Approval Historical past