Enrollment Reached Over 2,200 High-Risk Patients in Bemnifosbuvir Monotherapy Cohort
Results from SUNRISE-3 Expected in 2H’24
“COVID-19 continues to be a threat, leaving the most vulnerable at risk for severe outcomes from infection. The rapid pace of enrollment recently experienced in the monotherapy cohort of SUNRISE-3 highlights the continuing unmet medical need for new oral COVID-19 treatment options for high-risk patients, such as the elderly, immunocompromised and those with underlying risk factors,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Bemnifosbuvir was granted Fast Track designation by the
About the Phase 3 SUNRISE-3 Trial
The global, multicenter, randomized, double-blind, placebo-controlled Phase 3 SUNRISE-3 trial is evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC). SUNRISE-3 enrolled high-risk outpatients with mild or moderate COVID-19. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice daily (BID) or placebo BID for five days.
The trial is comprised of two study populations based on the type of SOC received: 1) the “supportive care population” evaluating bemnifosbuvir as monotherapy (primary analysis), and 2) the “combination antiviral population” assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis).
The primary endpoint of the SUNRISE-3 study is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort in approximately 2,200 high-risk patients. In addition, secondary endpoints will measure patient outcomes in the trial through Day 60 post-treatment.
In
The SUNRISE-3 patient population consists of those aged ≥70 years (regardless of other risk factors), individuals aged ≥55 years with one or more risk factors, those aged ≥50 years with two or more risk factors, and individuals aged ≥18 years with specific risk factors, including immunocompromised conditions, irrespective of COVID-19 vaccination status. Additionally, patients with reduced renal function were eligible for enrollment.
About Bemnifosbuvir for COVID-19
Bemnifosbuvir targets the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene which is responsible for both replication and transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism of action, with dual targets consisting of chain termination (RdRp) and nucleotityltransferase (NiRAN) inhibition, which has the potential to create a high barrier to resistance. In vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including Omicron subvariants BA.4, BA.5, XBB, EG.5.1 and JN.1.
About
Atea is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Currently, Atea is focused on the development of orally-available antiviral agents for serious viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus (HCV). For more information, please visit www.ateapharma.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the Company’s plans relating to and time of the anticipated release of the SUNRISE-3 results. When used herein, words including “expects,” “may,” “will,” “anticipates,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the important factors discussed and updated from time to time under the caption “Risk Factors” in the reports the Company files with the
Contacts
SVP, Investor Relations and Corporate Communications
617-818-2985
barnes.jonae@ateapharma.com
Will O’Connor
Stern Investor Relations
212-362-1200
will.oconnor@sternir.com
Source:
2024 GlobeNewswire, Inc., source