Our vision is to discover, develop and commercialize antibody-based solutions for the current COVID-19 pandemic and potential future coronavirus outbreaks. We currently have two ongoing global clinical trials evaluating our lead molecule, ADG20. These trials are currently enrolling patients.
Our vision is to discover, develop and commercialize antibody-based solutions for the current COVID-19 pandemic and potential future coronavirus outbreaks. We currently have two, ongoing global clinical trials evaluating our lead molecule, ADG20. These trials are currently enrolling patients.
Phase 2/3 STAMP Trial of ADG20 for the Treatment of COVID-19
The STAMP trial is designed as a double-blind, randomized, placebo-controlled clinical trial comparing the efficacy and safety of a single intramuscular dose of ADG20 to placebo in the prevention of COVID-19 related hospitalizations and all-cause death. The trial is enrolling ambulatory adult patients outside of the U.S. with mild to moderate COVID-19 who are at high risk of disease progression, with a target enrollment of approximately 1,100 patients.
After evaluation of safety data from the Phase 2 portion of the trial, we may expand enrollment to adolescents and pregnant women in the Phase 3 portion. The primary objectives of this clinical trial are to assess the safety and efficacy of ADG20 compared to placebo in the prevention of COVID-19-related hospitalization or all-cause death through Day 29.
For more information, please visit clinicaltrials.gov.
Phase 2/3 EVADE Trial of ADG20 for the Prevention of COVID-19
The EVADE trial is designed as 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 known, recent 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 and lactating women in Phase 3. The primary efficacy endpoint in both cohorts is the prevention of laboratory confirmed, symptomatic COVID-19.
For more information, please visit clinicaltrials.gov.
Expanded Access Policy
Adagio Therapeutics, Inc. is advancing the latest discoveries to develop safe and effective monoclonal antibodies that have the potential to prevent COVID-19, and to treat mild to moderate COVID-19. We are committed to bringing these important and innovative therapies to individuals who may benefit from them, and we embrace collaboration with individuals, families, physicians, researchers, and regulatory authorities to accomplish this goal and our mission.
Evaluation of an investigational therapy in clinical trials is the optimal way to collect the safety and efficacy information necessary to enable regulatory authority review and, ultimately, to support product approval and subsequent wider accessibility in the most efficient and expedient manner possible. Participation in a clinical trial is often the best way for an individual to access an investigational therapy. At Adagio, our goal is to expeditiously carry out robust clinical trials to generate the safety and efficacy data to support regulatory approvals, thereby providing the broadest possible access to individuals who might benefit from the therapy.
We understand that individuals and families may be interested in accessing Adagio Therapeutics’ investigational therapies prior to regulatory authorization and outside of the clinical trial setting through an expanded access program (sometimes referred to as “compassionate use” or “early access”). Currently, we do not have an expanded access program that permits access to our investigational products prior to regulatory authority (such as FDA) authorization. Wherever possible, use of an investigational product as part of a clinical trial is preferable because clinical trials generate data regarding the efficacy and safety of these products. Physicians and other health care providers, individuals, and caregivers interested in learning more about Adagio’s investigational therapies should contact Adagio at ExpandedAccess@adagiotx.com. We anticipate acknowledging receipt of inquiries sent to this email within five business days. Additional information regarding our clinical trials may be accessed on www.clinicaltrials.gov.
Statement on Stem Cell Research
Adagio Therapeutics Statement on Stem Cell Research
Our vision is to discover, develop and commercialize antibody-based solutions not only for the current COVID-19 pandemic, but also for potential future coronavirus outbreaks. To enable this vision, we are focused on advancing potent, broadly neutralizing antibodies that target conserved epitopes across multiple members of the coronavirus family. Critical to the successful development of therapeutic programs in the biopharma industry, is early-stage research to help us understand the complexities of human biology, how diseases are manifested and what therapeutic approaches may be taken to address the underlying causes of those diseases.
As is the case with many biopharma companies, at Adagio, we use a wide variety of research tools and technologies to help us discover and develop new treatments. Stem cells are one such tool, and in a very limited capacity, human embryonic stem cells that meet the highest ethical standards set by leading scientific authorities are used during the earliest stages of our research. This approach is essential to the field of drug discovery and development, providing important insights that have led and will continue to lead to the creation of new medicines that positively impact global health.
To support the manufacturing of our drug products, we have established a long-term agreement with an industry-leading contract manufacturing organization to produce drug product for both our ongoing clinical trials and future commercial supply. Our current drug products, including our lead monoclonal antibody investigational agent, ADG20, are produced using a common recombinant mammalian cell line, and at no point in our manufacturing process are human embryonic stem cells used.
As a company, Adagio honors a commitment to advancing products in an ethical and scientifically responsible manner, particularly while navigating the complex issues inherent in the biopharma industry. All of our research and manufacturing, including that which is conducted using stem cells, adheres to federal and state laws and regulations and we require the same level of adherence by all of our collaborators. In addition, we are continuously evaluating our practices to ensure they abide by the highest standards of scientific and bioethical integrity. We are dedicated to maintaining this rigorous approach to both our research and manufacturing so that we may advance medicines that combat global issues, such as the COVID-19 pandemic, and meaningfully impact people around the world.