Business Wire

Adagio Therapeutics Initiates Global Clinical Trial of ADG20 as a Treatment for COVID-19

Share

Adagio Therapeutics, Inc., a biotechnology company developing best-in-class antibodies to broadly neutralize coronaviruses, today announced the initiation of recruitment in its Phase 1/2/3 clinical trial to evaluate ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19. Known as the STAMP trial, this pivotal study will be conducted globally, including in regions with a high prevalence of SARS-CoV-2 variants of concern. The goal of the trial is to evaluate the ability of a single dose of ADG20 to prevent COVID-19 related hospitalizations and death. The company anticipates reporting initial results, with the potential for early patient access to treatment based on these data, by the end of 2021.

“We are thrilled to initiate this important trial, which we expect will establish the safety and efficacy of ADG20 for the treatment of mild to moderate COVID-19, including cases due to variants resistant to other antibody products,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “With its potential to address resistant variants and ability to be easily administered as a low dose, affordable, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for effective, safe and convenient outpatient therapy for individuals at high risk of disease progression. The initiation of the STAMP trial marks a critical step towards this goal, and we look forward to working closely with our sites and investigators to complete this trial.”

“ADG20 is the only antibody in development that possesses potent activity against SARS and all currently circulating SARS-CoV-2 variants of concern, including those resistant to other clinical-stage antibodies,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “Based on data that continue to emerge including the data published by the Screaton lab at the University of Oxford, we believe ADG20 has the potential to offer unsurpassed treatment and prevention not only of COVID-19 and its variants of concern but also future coronaviruses.”

The STAMP trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in patients with mild to moderate COVID-19 who are at high risk for disease progression. The study will be conducted across up to 100 sites worldwide and consists of two parts. Phase 1 will assess the safety and tolerability of a single dose of ADG20 in 30 ambulatory patients with COVID-19. Following this initial evaluation of safety, the seamless Phase 2/3 portion of the study will be initiated with the goal of preventing progression of disease, as assessed by the proportion of patients with COVID-19 related hospitalization or death within 29 days of study drug administration. The trial is strategically designed to enable the rapid advancement of ADG20 to proof-of-concept data, which if positive, are intended to support an Emergency Use Authorization submission by the end of 2021. For more information on the STAMP trial, please visit clinicaltrials.gov.

The clinical development program for ADG20 includes two additional trials. A Phase 1 clinical trial of ADG20 in healthy volunteers is currently underway, evaluating the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG20 doses, with initial data anticipated in the second quarter of 2021. Adagio also plans to initiate a Phase 2/3 trial (EVADE) in the prevention of COVID-19 in the second quarter of 2021.

University of Oxford Data Findings

In work recently published in Cell, researchers at the University of Oxford examined monoclonal antibody neutralization of authentic SARS-CoV-2 isolates, including Victoria (a strain similar to the original Wuhan strain) and newly emergent SARS-CoV-2 variants of concern, P.1 (originated in Brazil), B.1.351 (originated in South Africa) and B.1.1.7 (originated in the UK). Compared with other antibodies in development, preclinical data generated demonstrate that ADG20, as well as ADG10 and ADG30, show comparable or higher potency against all three variants of concern, including those resistant to other clinical stage antibodies. Separately, Adagio has also demonstrated that ADG20 shows no loss of binding activity against the recently emerged Southern California variant, CAL.20C, which contains the L452R mutation.

“The scale of the COVID-19 pandemic has led to significant levels of viral replication, increasing the chances that adaptive mutations will occur. ADG20 is distinguished from other antibodies targeting SARS-CoV-2 by virtue of its ability to effectively neutralize a broad range of clade I sarbecoviruses, including all SARS-CoV-2 variants of concern,” said Laura Walker, Ph.D., co-founder and chief scientific officer of Adagio. “These data further validate the differentiated features of ADG20 and support our confidence in its ability to treat and prevent COVID-19, as well as disease due to future outbreaks of other coronaviruses with pandemic potential.”

About ADG20

ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is formulated at high concentrations, enabling intramuscular administration for both prevention and treatment of COVID-19, and was engineered to have a long half-life, allowing for immediate and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics

Adagio is developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV and additional pre-emergent coronaviruses. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and are designed to provide patients and clinicians with an unsurpassed combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

EAG Expands Medical Device Testing Services with New Laboratory7.5.2021 17:22:00 CEST | Press release

EAG Laboratories is expanding its medical device testing capabilities with a new 20,000 square-foot laboratory located in St. Louis, Mo. The new laboratory is a bespoke design to support the requirements of the medical device industry. It increases EAG’s analytical capabilities, allows for improved turnaround times and helps meet evolving requirements from the FDA as well as the European Union Medical Device Regulations (MDR). Specialty features of the laboratory include: A cleanroom designed for particle isolation and identification A dedicated medical device polymer analysis laboratory State-of the-art instrumentation to support biocompatitility testing of ISO 10993-18 programs for medical devices and combination products EAG scientists have been investigating and resolving product failures for more than half a century and have a deep understanding of materials and testing procedures. The medical device laboratory expansion allows EAG to leverage that knowledge and apply it toward su

SoftServe Wins Learning and Development Honor at 2021 ATD Excellence in Practice Awards7.5.2021 13:00:00 CEST | Press release

SoftServe, a leading digital authority and consulting company, won the Excellence in Practice Award in the ‘Learning and Development’ category in the 2021 Association for Talent Development (ATD) Excellence in Practice Awards. SoftServe was recognized for its corporate learning hub, SoftServe University, which focuses on learning and development opportunities for associates, including the design and delivery of training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210507005003/en/ Association for Talent Development logo. (Photo: Business Wire) “SoftServe is dedicated to creating a people-centric organization that allows associates to grow and develop professionally,” said Galyna Datsiv, AVP of Learning and Development at SoftServe. “Our corporate learning ecosystem within the integrated talent management framework enables us to reach SoftServe’s strategic business goals by ensuring associates are qualified and have the ex

Monument Assurance Belgium and Intégrale Reach Agreement for the Transfer of Intégrale's Entire Portfolio and Staff to MAB7.5.2021 12:26:00 CEST | Press release

Monument Assurance Belgium (“MAB”) and Intégrale have reached an agreement under which MAB will acquire the entire portfolio and all the staff of the insurance company Intégrale. This agreement follows a firm offer from MAB, which was considered by the provisional administrators appointed by the National Bank of Belgium (“NBB”) to be that which best meets the interests of Intégrale policyholders and staff. The transaction remains subject to the final approval of the NBB. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210507005270/en/ During the transition period, MAB and Intégrale will take all steps necessary to prepare for a seamless transfer for policyholders, brokers and staff. In the meantime, Intégrale's staff will continue to service policyholders and brokers as usual. In addition to the transfer of assets at the time of closing, MAB will offer an 18-month employment guarantee to all employees and, in addition, a 3-mo

The Metals Company Joins European Industry Alliances to Bolster Battery Supply Chain for the Clean Energy Transition7.5.2021 10:00:00 CEST | Press release

Today, The Metals Company (formerly DeepGreen), a developer of the world’s largest and highest-grade estimated source of battery metals, announced it has joined two of the European Union’s foremost industrial alliances—the European Raw Materials Alliance (ERMA) and the European Battery Alliance (EBA)—as the bloc advances its plans to become a global leader in the sustainable production of the batteries necessary to store clean energy and power electric vehicles (EVs). As a member of these industrial alliances, The Metals Company—which announced in March its plans to go public via a merger with the Sustainable Opportunities Acquisition Corporation (NYSE: SOAC)—brings a new, scalable source of battery metals to the table in the form of polymetallic nodules found unattached on the deep seafloor in the Pacific Ocean, which can help deliver upon their mandate for a diverse, reliable and responsible supply of critical minerals needed for low-carbon technologies. Under its Green Deal, the Eur

Morocco and UN Celebrate First-Ever International Argan Tree Day7.5.2021 08:30:00 CEST | Press release

Morocco and the United Nations will be marking the first-ever International Argan Tree Day on May 10th, 2021. The Argan tree, a tree specific to the Kingdom of Morocco, will thus be celebrated every year on May 10, as an intangible cultural heritage of humanity and ancestral source of sustainable development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210506005652/en/ February 22, 2021: The United Nations’ General Assembly adopted by consensus a resolution proclaiming May 10 of each year as the “International Argan Tree Day” (Photo: AETOSWire) The proclamation of the International Argan Tree Day was announced on March 3, 2021, when the UN General Assembly adopted by consensus a draft resolution initiated by Morocco and hailed by all United Nations’ member states. This milestone is a culmination of Morocco’s quest to mobilize the international community to protect and further develop the country’s Argan industry. It is al

Tigo Energy Demonstrates Optimization to Installers in Brazil with Stark Renováveis Installation7.5.2021 02:14:00 CEST | Press release

Tigo Energy, Inc., the solar industry’s leading Flex MLPE (Module Level Power Electronics) supplier, announced today that Stark Renováveis has used the Tigo TS4-A-O to mitigate energy lost due to shade on their corporate headquarters in São José do Rio Preto, Brazil. Their confidence in Tigo’s solution drove the selection of the products for their own use. The Tigo solution gives installers and commercial system owners the freedom to choose their preferred inverters and panels along with the right features for optimized, monitored and PV safe systems. The Stark Renováveis team chose a rooftop PV system with 405 Wp modules organized in multiple strings and using GoodWeTM grid-tied inverters. The optimum placement of the modules was on a roof bordering a large construction wall which would ordinarily lead to shade and a degradation of the output. To mitigate the problem of energy lost due to shade, Tigo TS4-A-O optimizers were deployed to ensure the best possible system performance. "As

93 rd Vifor Pharma Group Annual General Meeting6.5.2021 18:00:00 CEST | Press release

Regulatory News: At today’s 93rd Annual General Meeting of Vifor Pharma Ltd., shareholders approved all proposed resolutions put forward by the Board of Directors. In view of the ongoing COVID-19 pandemic and in accordance with Ordinance 3 on measures to combat the coronavirus issued by the Swiss Federal Council, on the basis of Art. 8 of the new COVID-19 Act, shareholders were not permitted to attend the event in person. Shareholders exercised their rights exclusively through the independent proxy and 61.6% of the share capital was represented. Shareholder approvals Shareholders approved the Annual Report and the Annual Financial Statements of Vifor Pharma Ltd., as well as the consolidated Financial Statements of Vifor Pharma Group for 2020 by a large majority. The maximum possible 2022 remuneration for the Board of Directors and Executive Committee was also approved, as well as the 2020 Remuneration Report in a consultative vote. In addition, shareholders discharged the members of th

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom