Business Wire

Adagio Therapeutics Announces ADG20 Phase 1 Data and Initiation of Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Share

Adagio Therapeutics, Inc., a biotechnology company developing highly differentiated antibodies to broadly neutralize coronaviruses, today announced that the first patient has been treated in the company’s Phase 2/3 pivotal trial evaluating ADG20 for the prevention of COVID-19, known as the EVADE trial. Trial initiation is supported by positive preliminary data from the company’s ongoing Phase 1 trial in healthy volunteers. EVADE will be conducted globally at more than 100 sites, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, and will evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.

The initiation of the EVADE trial is supported by blinded data from Adagio’s ongoing first-in-human, randomized, placebo-controlled Phase 1 clinical trial. The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG20 dose regimens. Preliminary data demonstrate that a single intramuscular injection of ADG20 is well tolerated at doses up to 600 mg, and the initial pharmacokinetic profile support a prolonged serum half-life, which has the potential to afford up to 12 months of protection against COVID-19. In addition, initial ADG20 serum virus neutralizing activity against authentic SARS-CoV-2 is similar to peak serum neutralizing antibody titers reported for mRNA COVID-19 vaccine recipients.

“We are pleased with the strength of our initial clinical data and with the initiation of the EVADE trial to assess the efficacy of ADG20 in two key settings for the prevention of symptomatic COVID-19,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “Based on its potent and broad activity and extended duration of effect in preclinical models, we believe that ADG20 has the potential to provide both rapid protection in the face of a known, recent exposure to an individual with SARS-CoV-2 infection as well as durable protection over several months, including for individuals who are unlikely to have a sufficiently protective immune response to vaccines. We appreciate the enthusiasm expressed by our investigators and their support in advancing this differentiated antibody therapy.”

“COVID-19 continues to be a significant health crisis, and with the recurring emergence of new variants across the globe, we believe a broadly neutralizing therapy that could be given for both treatment and prevention will be necessary,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio.

The EVADE trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in two independent cohorts. The first cohort (post-exposure prophylaxis) is designed to assess the safety and efficacy of ADG20 compared to placebo for the prevention of COVID-19 after exposure to an individual with laboratory confirmed SARS-CoV-2 infection. The second cohort (pre-exposure prophylaxis) is designed to assess the efficacy and safety of ADG20 compared to placebo in individuals who are at increased risk for SARS-CoV-2 infection due to occupational, housing or recreational situations, and in individuals who are at increased risk of poor vaccine response, including individuals with compromised immune systems or other co-morbidities. After evaluation of data from the first 200 adult participants in the Phase 2 portion of the trial, enrollment may be opened to adolescents and pregnant women in Phase 3. The primary efficacy endpoint in both cohorts is the prevention of laboratory confirmed, symptomatic COVID-19. For more information on the EVADE trial, please visit clinicaltrials.gov.

The clinical development program for ADG20 includes two additional trials: the ongoing Phase 1 clinical trial of ADG20 in healthy volunteers and the ongoing STAMP trial evaluating ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19 (see clinicaltrials.gov).

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, and was engineered to have a long half-life, with a goal of providing both rapid 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:
Dan Budwick, 1AB
Dan@1abmedia.com

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 12:13:00 EEST | Press release

SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag

Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 02:00:00 EEST | Press release

The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster than the global economy, generating significant commercial opportunities as long as the mounting challenges of climate change, labour shortages and infrastructure gaps are addressed. Inbound and outbound trips increasing fast Asia is on track to become the world’s fastest-growing tourism economy, with the direct travel and tourism GDP contribution expected to exceed 7% across the region by 2034. Notably, India and China

The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 22:00:00 EEST | Press release

The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate

Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release

Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac

Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release

In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye