A phase 2, open-label study to assess the safety and efficacy of Bemnifosbuvir (bem) and Ruzasvir (rzr) in subjects with chronic hepatitis c virus (hcv) infection

Start Date08 Jan 2024

Sponsor / Collaborator

Atea Pharmaceuticals, Inc.

[+1]

NCT06204679

/ CompletedPhase 1

A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects

This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects

Start Date14 Dec 2023

Sponsor / Collaborator

Atea Pharmaceuticals, Inc.

NCT05904470

/ CompletedPhase 2

A Phase 2, Open-label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects with Chronic Hepatitis C Virus (HCV) Infection

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

Start Date30 May 2023

Sponsor / Collaborator

Atea Pharmaceuticals, Inc.

100 Clinical Results associated with Ruzasvir

100 Translational Medicine associated with Ruzasvir

100 Patents (Medical) associated with Ruzasvir

Literatures (Medical) associated with Ruzasvir

01 May 2025·ANTIVIRAL RESEARCH

Bemnifosbuvir and ruzasvir in combination exhibit potent synergistic antiviral activity in vitro while maintaining a favorable nonclinical safety profile in vivo

Article

Author: Lin, Kai ; Good, Steven S ; Sommadossi, Jean-Pierre ; Luo, Shouqi ; Vo, Alex ; Agrawal, Nancy G B

Bemnifosbuvir (BEM), the orally available hemisulfate salt of the double prodrug of a guanosine nucleotide analog, is a potent, selective, and pan-genotypic inhibitor of HCV nonstructural protein 5B, an RNA-dependent RNA polymerase necessary for viral replication. Similarly, ruzasvir (RZR) is an orally available, highly potent, selective, and pan-genotypic inhibitor of HCV nonstructural protein 5A, an essential component of the viral replication complex. The antiviral effects of the combination of these two complementary direct-acting antivirals were determined in HCV GT1b Huh-7 replicon cells. Two independent in vitro evaluations suggested that BEM and RZR act synergistically to inhibit HCV replication without accompanying cytotoxicity. Additionally, the toxicity and toxicokinetic properties of BEM and RZR administered individually or in combination were investigated in rats given daily oral doses at 500 mg/kg of each drug for 13 weeks, with an interim analysis at 4 weeks. All doses were well tolerated with no test article-related adverse effects identified in either the separate or combined dose groups. Moreover, toxicokinetic analyses conducted on dose days 1, 28 and 84 indicated minimal pharmacokinetic interactions between the two drugs in rats, with AUC values for AT-511 (free base form of BEM), its major circulating metabolites, and RZR being similar, regardless of separate or co-administration.

01 Feb 2020·BMJ case reports

Glecaprevir/pibrentasvir+sofosbuvir: an optimal retreatment strategy in the setting of HCV NS5A resistance

Article

Author: Alimohammadi, Arshia ; Conway, Brian ; Yamamoto, Leo

Some individuals do not achieve a cure of their hepatitis C virus (HCV) infection due to non-adherence or resistance associated substitutions. Salvage options that are optimised for resistance profiles are essential. We report a 56-year-old Caucasian man with fatigue, depression and confusion in the setting of untreated HCV genotype 3a infection. He received ruzasvir and uprifosbuvir for 12 weeks within a clinical trial. The patient relapsed 4 weeks after the end of treatment and at this time resistance testing showed multiple resistances including a NS5A Y93H mutation. Given that this mutation confers resistance to first line salvage options, sofosbuvir and glecaprevir/pibrentasvir was used for 12 weeks and the patient was cured of HCV infection 12 weeks after the end of treatment. This shows that sofosbuvir and glecaprevir/pibrentasvir is a viable, effective option for second line/salvage therapy of HCV infection in the setting of resistance to NS5A inhibitors with the Y93H mutation.

01 Sep 2019·Journal of viral hepatitisQ2 · MEDICINE

Efficacy and safety of a two‐drug direct‐acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6

Q2 · MEDICINE

Article

Author: Jackson, Beth ; Burnevich, Eduard ; Gane, Edward ; Klopfer, Stephanie ; Rabinovitz, Mordechai ; Buti, Maria ; Platt, Heather L. ; Lawitz, Eric ; Feld, Jordan J. ; Barr, Eliav ; Katchman, Helena ; Lahser, Fred ; Yeh, Wendy W. ; Hanna, George J. ; Shaughnessy, Melissa ; Tomasiewicz, Krzysztof ; Robertson, Michael N. ; Foster, Graham R.

Abstract:

Ruzasvir (MK‐8408, an NS5A inhibitor) and uprifosbuvir (MK‐3682, a nonstructural protein 5B nucleotide inhibitor) are highly potent direct‐acting antiviral agents for the treatment of hepatitis C virus (HCV) infection. A phase III clinical trial evaluating the two‐drug combination of ruzasvir 60 mg plus uprifosbuvir 450 mg suggested suboptimal efficacy in certain HCV genotypes (C‐BREEZE 1; NCT02759315). The aim of the present study was to evaluate the efficacy and safety of ruzasvir in combination with uprifosbuvir administered at a higher dose than that assessed in the earlier study (C‐BREEZE 2: NCT02956629/Merck protocol PN041). Treatment‐naïve or interferon (with or without ribavirin)‐experienced participants with or without compensated cirrhosis were enrolled. All participants received ruzasvir 180 mg plus uprifosbuvir 450 mg once daily for 12 weeks. The primary objectives were the proportion of participants with HCV RNA <15 lU/mL at 12 weeks after the end of study therapy (SVR12), and safety and tolerability of the study drug. Overall, 282 participants were enrolled. SVR12 (n/N) was 91.3% (42/46) in participants infected with HCV genotype (GT) 1a; GT1b, 96.7% (29/30); GT2, 91.5% (43/47); GT3, 73.8% (45/61); GT4, 98.2% (55/56); GT5, 100.0% (18/18); and GT6, 90.9% (20/22). Adverse events (AEs) were reported by 61.3% of participants; drug‐related AEs were reported by 33.3%. The most frequent (≥5% of participants) drug‐related AEs in all participants were fatigue (7.8%) and headache (7.4%). In conclusion, the two‐drug combination of ruzasvir 180 mg plus uprifosbuvir 450 mg for 12 weeks was highly effective and well tolerated in participants infected with HCV GT1, GT2, GT4, GT5 and GT6, with a lower efficacy in GT3‐infected persons.

News (Medical) associated with Ruzasvir

19 Mar 2025

·www.globenewswire.com

Atea Pharmaceuticals Announces Presentation of Bemnifosbuvir Preclinical Data at the 38th International Conference on Antiviral Research (ICAR) 2025

BOSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the poster presentation of bemnifosbuvir preclinical data at the 38th International Conference on Antiviral Research (ICAR) 2025 taking place March 17-21, 2025 in Las Vegas, Nevada. “The results presented at ICAR highlight Atea’s deep scientific expertise in antiviral drug development by demonstrating metabolism of nucleotide prodrugs, such as bemnifosbuvir, is highly cell-line dependent and cell model selection needs to be taken into account when evaluating in vitro antiviral efficacy,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea. “Bemnifosbuvir is being developed in a fixed dose combination regimen with ruzasvir for the treatment of hepatitis C virus (HCV). We look forward to starting patient enrollment in the Phase 3 program evaluating this potential best-in-class HCV regimen in April.” Details for the poster presentation are as follows: Poster Number: 500 Date and Time: Tuesday, March 18, 2025, 5:30 - 7:30 PM PDT and Thursday, March 20, 2025, 8:00 - 10:00 AM PDT Title: Metabolism of Bemnifosbuvir to its Active Triphosphate Metabolite AT-9010 is Cell-Line Dependent Bemnifosbuvir (BEM), an oral prodrug of a 6-modified guanosine nucleotide analog, is a potent HCV NS5B inhibitor being developed in a fixed dose combination regimen with ruzasvir, a highly potent NS5A inhibitor for the treatment of chronic HCV infection. The activation of BEM is mediated by cellular enzymes including CatA/CES1, HINT1, ADALP1, GUK1, and NDPK to yield the intracellular active triphosphate metabolite AT-9010. In this preclinical study, the metabolism of BEM to its active triphosphate was demonstrated to be cell-line dependent, indicating that cell model selection is critical when evaluating in vitro efficacy of antiviral prodrugs such as BEM. Global Phase 3 Program for Hepatitis C Virus (HCV) Based upon a successful engagement with the US Food and Drug Administration (FDA) at the End-of-Phase 2 meeting in January 2025, Atea is initiating a global Phase 3 program and expects patient enrollment to start in April 2025. In December 2024, Atea announced that its Phase 2 study evaluating the regimen of BEM and ruzasvir for the treatment of HCV, met its primary endpoints. Atea plans to conduct two open label Phase 3 trials, one in the US and Canada and one outside of North America. Each Phase 3 trial is expected to enroll approximately 800 treatment-naïve patients, including those with and without compensated cirrhosis. For patients without cirrhosis, 8 weeks of the regimen of BEM and ruzasvir will be compared to 12 weeks of the regimen of sofosbuvir (SOF) and velpatasvir. For patients with compensated cirrhosis, 12 weeks of the regimen of BEM and ruzasvir will be compared to 12 weeks of the regimen of sofosbuvir and velpatasvir. In the US, it is estimated that more than 90% of people with HCV are non-cirrhotic. The primary endpoint for both trials encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm and is HCV RNA < lower limit of quantitation (LLOQ) 24 weeks from the start of treatment. Measurement at 24 weeks from the start of treatment is selected to ensure the primary endpoint occurs at the same relative timepoint from start of treatment in all patients. About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV) BEM has been shown in in vitro studies to be approximately 10-fold more active than SOF against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated BEM remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The PK profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. BEM has been shown to have a low risk for drug-drug interactions. BEM has been administered to over 2,300 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 2,100 subjects at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About Hepatitis C Virus (HCV) HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with 242,000 deaths occurring each year. Despite the availability of direct-acting antivirals, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, between 2.4 and 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. About Atea Pharmaceuticals 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 Atea’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. Our lead program and current focus is on the development of the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat 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 statements regarding the development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, including the anticipated initiation of patient enrollment in the Phase 3 program, and the potential best in class profile of the regimen . When used herein, words including “expected,” “should,” “anticipated,” “believe.” “will,” “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 Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea 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 timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Annual Report on Form 10-K for the year ended December 31, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Joyce AllaireLifeSci AdvisorsJallaire@lifesciadvisors.com

Phase 3Phase 2Clinical ResultOligonucleotide

13 Jan 2025

·www.globenewswire.com

Atea Pharmaceuticals to Highlight 2025 Strategic Priorities at the 43rd Annual J.P. Morgan Healthcare Conference

Global Phase 3 HCV Program Expected to Initiate in 1Q 2025 Potential Best-in-Class Profile of Bemnifosbuvir + Ruzasvir Regimen Supports Opportunity to Disrupt and Expand Global HCV Market of Approximately $3 Billion in Annual Net Sales The Regimen, if Approved, Should Play an Important Role in Efforts to Reduce the Continuing High Disease Burden of HCV BOSTON, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, will outline the Company’s strategic priorities for 2025 at the 43rd Annual J.P. Morgan Healthcare Conference. Atea will present its plans for the regimen of bemnifosbuvir and ruzasvir, which the Company is advancing into a Phase 3 program for the treatment of Hepatitis C virus (HCV) and present data from market research studies supporting the commercial market opportunity. Further information can be found in the Company’s presentation here. The Company also reports its cash, cash equivalents and marketable securities balance of $454.7 million at December 31, 2024 and a cash runway anticipated into 2028. Despite the availability of direct-acting antivirals, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, between 2.4 and 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. “Atea has an exciting year ahead with our planned initiation of a global Phase 3 program for the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. Our potential best-in-class regimen offers drug potency and forgiveness with convenient, short treatment duration, low risk of drug-drug interactions and no food effect. Our US market research confirms that this profile provides a significant opportunity to address the large burden of untreated HCV disease and play a major role in the eradication of HCV,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea. “We believe our regimen, if approved, has the opportunity to disrupt the global HCV market of approximately $3 billion in annual net sales.” In recent surveys conducted for Atea, US healthcare providers report a high likelihood of prescribing the regimen of bemnifosbuvir and ruzasvir, if approved, and US payors are receptive to inclusion of the regimen on formulary based on its differentiated profile.1 Anticipated Global Phase 3 Program for HCV In December 2024, Atea announced that its Phase 2 study evaluating the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for treatment of hepatitis C virus (HCV), met its primary endpoints. Based on these positive results, Atea has an End-of-Phase 2 meeting scheduled with the US Food and Drug Administration later this month to review the Phase 3 program. In the global Phase 3 program, Atea expects to conduct two open label Phase 3 trials, one in the US and Canada and one outside of North America. Each trial will enroll up to 800 treatment-naïve HCV patients, both with and without compensated cirrhosis. For non-cirrhotic patients, who comprise more than 90% of patients in the US, Atea expects to evaluate the efficacy of eight weeks of treatment in with the once-daily fixed dose tablet of bemnifosbuvir and ruzasvir versus 12 weeks of treatment with sofosbuvir/velpatasvir. For cirrhotic patients, 12 weeks of treatment with the once-daily fixed dose tablet of bemnifosbuvir and ruzasvir will be evaluated versus 12 weeks of treatment with sofosbuvir/velpatasvir. The primary endpoint is expected to be sustained virologic response at 12 weeks post-treatment (SVR12). About the Phase 2 Study The global Phase 2 study evaluating the regimen of bemnifosbuvir and ruzasvir for treatment of HCV met its primary endpoints of safety and SVR12. Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with the regimen of bemnifosbuvir and ruzasvir. The efficacy evaluable patient population, which included 17% treatment non-adherent patients, achieved a 95% (242/256) SVR12 rate demonstrating the robust potency and forgiveness of the regimen. The regimen was generally safe and well-tolerated with no drug-related serious adverse events or treatment discontinuations. Full data from the Phase 2 study are anticipated to be presented at a scientific meeting during the first half of 2025. The global Phase 2 study enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis. The study was designed to evaluate the safety and efficacy of eight weeks of treatment with the regimen consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg. The primary endpoints of the study were safety and SVR12 in the per-protocol treatment adherent population. Secondary and other endpoints included SVR12 in the per-protocol population regardless of treatment adherence (efficacy evaluable), virologic failure and resistance. About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV) Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated that bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About Hepatitis C Virus (HCV) HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with 242,000 deaths occurring each year. Most HCV-related deaths are due to liver scarring (cirrhosis) and liver cancer (hepatocellular carcinoma). HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of the HCV infected patients in the US have cirrhosis. About Atea Pharmaceuticals 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 Atea’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. Our lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat 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 statements regarding the development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV and the ability of the regimen, if approved, to disrupt and expand the global HCV market, reduce the continuing high disease burden and contribute to the eradication of HCV. When used herein, words including “expected,” “should,” “anticipated,” “believe.” “will,” “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 Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea 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 timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Will O’ConnorPrecision AQ212-362-1200will.oconnor@precisionaq.com _______________________________1 Atea Custom Research, PharmaValue Partners 2023 and Atea Custom Research, Formulary Insights 2024

Clinical ResultPhase 3Phase 2

16 Dec 2024

·www.globenewswire.com

Atea Pharmaceuticals Retains Financial Advisor to Explore Strategic Partnerships

BOSTON, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that it has engaged Evercore, a global independent investment bank, to identify potential opportunities to enhance shareholder value, including the exploration of strategic partnerships related to its Phase 3-ready program for the treatment of hepatitis C virus (HCV). The Company has not set a timetable for the conclusion of its review and has not made any decisions at this time. The Company does not intend to comment further with respect to this review unless or until its Board of Directors has approved a definitive course of action, the review process has concluded, or it is determined that other disclosure is appropriate. There is no assurance that this process will result in the completion of any specific transaction or outcome. About Atea Pharmaceuticals 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 Atea’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. Our lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, to treat hepatitis C virus. 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 statements regarding Atea’s exploration of potential strategic partnerships related to its HCV program and the development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. When used herein, words including “will,” “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 Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea 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 timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Will O’ConnorPrecision AQ212-362-1200will.oconnor@precisionaq.com

OligonucleotidePhase 3

100 Deals associated with Ruzasvir

External Link

KEGG	Wiki	ATC	Drug Bank
D11217	-	-	DB11713

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Compensated cirrhosis	Phase 2	United States	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Brazil	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Canada	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	India	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Mauritius	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Pakistan	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Philippines	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Romania	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	South Africa	Atea Pharmaceuticals, Inc.	30 May 2023
Compensated cirrhosis	Phase 2	Turkey	Atea Pharmaceuticals, Inc.	30 May 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05904470 (AT-01B-004, GlobeNewswire) Manual	Phase 2	Hepatitis C	275	Bemnifosbuvir 550 mg + Ruzasvir 180 mg	pdjxgmtkjc(xrfsxiqvxd) = ytfvzqwwkb csxlidpuid (pfvmxvqznp ) Met	Positive	04 Dec 2024
				Bemnifosbuvir 550 mg + Ruzasvir 180 mg (non-cirrhotic and infected with genotypes 1-4)	pdjxgmtkjc(xrfsxiqvxd) = ytynnxeehc csxlidpuid (pfvmxvqznp ) Met
NCT02956629 (C-BREEZE 2 \| MK-3682-041 \| 3682-041, Pubmed \| J Viral Hepat) Manual	Phase 2	Hepatitis C, Chronic	282	Ruzasvir+uprifosbuvir	izrgcpxrbj(scokpfzljj) = yftonmkrpu ildalartjc (nfksgxucuc ) View more	Positive	01 Sep 2019
NCT02759315 (3682-035 \| MK-3682-035, Pubmed \| J Viral Hepat)	Phase 2	Hepatitis C	160	Ruzasvir 60 mg + Uprifosbuvir 450 mg	ssiwnlziel(tdttwnzjuo) = euppgxhnyd mkylygvyti (hlpfvhoagk )	-	01 Jun 2019
NCT02956629 (C-BREEZE 2 \| MK-3682-041 \| 3682-041, CTgov)	Phase 2	Hepatitis C, Chronic	282	Uprifosbuvir+Ribavirin+Ruzasvir (HCV GT1)	exispujpug = otjijpzrha sjigwywiiq (ifbejekcra, uxsnhzrgij - itwsftjrtp) View more	-	26 Dec 2018
				Uprifosbuvir+Ribavirin+Ruzasvir (HCV GT2)	exispujpug = csqznfshid sjigwywiiq (ifbejekcra, fkspsywnow - mzvknaxbwr) View more
NCT02076100 (8408-003 \| MK-8408-003, CTgov)	Phase 1	Hepatitis C	22	Ruzasvir (Ruzasvir 10 mg - GT3)	lwedthcthq(zfmghwkvcw) = xznzllsnuc xhkptofvpz (jdcnymxvko, hpbwvubzgd - pnosrprxei) View more	-	28 Nov 2018
				Ruzasvir (Ruzasvir 30 mg - GT3)	lwedthcthq(zfmghwkvcw) = gpxiystwmk xhkptofvpz (jdcnymxvko, ejkwduswqq - bbkbyewzoo) View more
NCT02666352 (3682-029, CTgov)	Phase 1	Hepatitis C, Chronic	24	Uprifosbuvir+Ruzasvir (Moderate HI Participants)	gwdfpuizgr(mdbtsbeoto) = ajafrdgjhh wrnxavosra (zcfpybkljc, fdkkktxzww - cpiiyawvfp) View more	-	17 Sep 2018
				Uprifosbuvir+Ruzasvir (Severe HI Participants)	gwdfpuizgr(mdbtsbeoto) = snzjwtwluu wrnxavosra (zcfpybkljc, imdoacvsbp - giqwpuaiku) View more
NCT02759315 (3682-035 \| MK-3682-035, CTgov)	Phase 2	Chronic hepatitis C genotype 1	160	Uprifosbuvir 450 mg+Ruzasvir 60 mg (GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg)	jhtfqqehen = svaadzsoqj zlonumubwz (drvaztirev, qpdmsvqras - anhuclgupk) View more	-	06 Aug 2018
				Uprifosbuvir 450 mg+Ruzasvir 60 mg (GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg)	jhtfqqehen = lmvotbeueo zlonumubwz (drvaztirev, wuwxpmebug - tguhsaugbx) View more
NCT02332707 \| NCT02332720 (C-CREST-1 and C-CREST-2, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 2	Liver Cirrhosis \| Hepatitis C, Chronic	676	Grazoprevir, ruzasvir, and uprifosbuvir with ribavirin	qjmsxqytya(mbyxzyiekl) = ficzkccakw vgleycwaos (ebcpcmgrdu, 81 - 99)	-	01 Nov 2017
				Grazoprevir, ruzasvir, and uprifosbuvir without ribavirin	qjmsxqytya(mbyxzyiekl) = nvblptaufu vgleycwaos (ebcpcmgrdu, 88 - 100)

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