{"id":36253,"date":"2021-11-15T11:37:11","date_gmt":"2021-11-15T11:37:11","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=82475"},"modified":"2021-11-15T11:37:11","modified_gmt":"2021-11-15T11:37:11","slug":"adagio-therapeutics-provides-update-for-adg20-covid-19-antibody-program-and-reports-third-quarter-2021-financial-results","status":"publish","type":"post","link":"https:\/\/southafricavoice.com\/adagio-therapeutics-provides-update-for-adg20-covid-19-antibody-program-and-reports-third-quarter-2021-financial-results\/","title":{"rendered":"Adagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results"},"content":{"rendered":"
FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention of COVID-19; Interim Clinical Data Package from EVADE Prevention Trial to Support EUA Submission Expected in Second Quarter 2022<\/em><\/p>\n Enrollment Progressing in ADG20 STAMP Trial for Treatment of COVID-19; Planned Interim Efficacy Analysis Expected in Second Quarter 2022 to Support Potential EUA Submission <\/em><\/p>\n WALTHAM, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update on its lead COVID-19 antibody program, ADG20, and reported third quarter 2021 financial results. ADG20 is an investigational monoclonal antibody product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19.<\/p>\n \u201cADG20 continues to be the only monoclonal antibody in late-stage development that has the potential to offer a unique combination of potency, breadth of neutralization across known SARS-CoV-2 variants of concern as well as additional SARS-like viruses with pandemic potential, and durable protection against COVID-19 for up to one year. Further, our single injection delivery avoids the inconveniences associated with IV administration or multiple injections,\u201d said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. \u201cThe world continues to face a host of challenges in fully addressing the COVID-19 crisis. Alternatives or supplements to vaccines for the prevention of COVID-19 are needed for immunocompromised individuals and those who remain hesitant to receive a vaccine or to vaccinate their children. Certain patient populations may not be ideal candidates for emerging oral treatment options due to adherence concerns, comorbidities or possible drug interactions. Based on its combined attributes, ADG20 has the potential to be a differentiated alternative for the prevention and treatment of COVID-19 that may address the needs of these populations, and our commitment to its advancement is unwavering.\u201d<\/p>\n \u201cWe\u2019ve made significant progress over the course of 2021, and 2022 is set to be a landmark year for Adagio as we prepare for potential EUA submissions for ADG20 for the prevention and treatment of COVID-19,\u201d said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. \u201cWe recently received clear feedback from the FDA on a strategy to submit an EUA for ADG20 for the prevention of COVID-19, and have initiated efforts to expand our clinical program to additional patient subsets, including immunocompromised individuals and children. Our commercial-readiness efforts are well underway and with a strong balance sheet, we are ready to move quickly to enable access to individuals in need of COVID-19 prevention and treatment options, if authorization and\/or approval is granted.\u201d<\/p>\n ADG20 COVID-19 Program Updates<\/u><\/strong><\/p>\n Prevention<\/em><\/strong> Treatment <\/em><\/strong> Recent ADG20 Data Presentations at ISIRV-WHO and IDWeek2021<\/em><\/strong><\/p>\n Intellectual Property <\/em><\/strong><\/p>\n On October 29, 2021, the United States Patent and Trademark Office mailed a notice of allowance to the company for a patent application that will provide patent protection for ADG20 in the U.S.<\/p>\n Third Quarter 2021 Financial Results<\/u><\/strong><\/p>\n About ADG20<\/strong> About Adagio Therapeutics<\/strong> Forward Looking Statements<\/strong> Contacts: <\/strong>
\nAdagio continues to enroll adult and adolescent participants in its ongoing, global Phase 3 EVADE clinical trial evaluating ADG20 as a prevention for COVID-19 in both the pre-exposure and recent exposure settings.<\/p>\n\n
\nAdagio continues to enroll patients in its ongoing, global Phase 2\/3 STAMP clinical trial evaluating ADG20 as a treatment for COVID-19.<\/p>\n\n
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\nADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is advancing through global clinical trials 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 activity against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half-life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS-CoV-2 virus, all known SARS-CoV-2 variants of concern and additional SARS-like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well-tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow-up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.<\/p>\n
\nAdagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company\u2019s portfolio of antibodies has been optimized using Adimab\u2019s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio\u2019s 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 to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com<\/a>.<\/p>\n
\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as \u201canticipates,\u201d \u201cbelieves,\u201d \u201cexpects,\u201d \u201cintends,\u201d \u201cprojects,\u201d and \u201cfuture\u201d or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA submissions, initiation, modification and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the benefits of our product candidates to patients; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates.<\/em> We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading \u201cRisk Factors\u201d in Adagio\u2019s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in Adagio\u2019s future reports to be filed with the\u00a0SEC, including Adagio\u2019s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.<\/em><\/p>\n
\nMedia Contact:<\/strong>
\nDan Budwick, 1AB
\nDan@1abmedia.com<\/a><\/p>\n