Atea Pharmaceuticals Announces Dosing of First Patient in C-BEYOND, Phase 3 Study Evaluating Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus
Atea Pharmaceuticals (NASDAQ: AVIR) has initiated its Phase 3 trial C-BEYOND, dosing the first patient to evaluate the combination of bemnifosbuvir and ruzasvir for treating chronic hepatitis C virus (HCV). The open-label trial, conducted in the US and Canada, compares this regimen to sofosbuvir and velpatasvir.
The bemnifosbuvir-ruzasvir regimen will be administered once-daily for 8 weeks in patients without cirrhosis and 12 weeks in patients with compensated cirrhosis. The trial's control arm will receive a 12-week treatment.
The company aims to address the significant global HCV burden, affecting approximately 50 million people worldwide, with 1 million new infections annually. In the US alone, 2.4-4 million people are estimated to have HCV, with new infections exceeding treatment rates. The new regimen offers potential advantages including shorter treatment duration, low drug-drug interaction risk, and no food effect requirements.
Atea Pharmaceuticals (NASDAQ: AVIR) ha avviato il suo studio di Fase 3 C-BEYOND, somministrando il primo paziente per valutare la combinazione di bemnifosbuvir e ruzasvir per il trattamento dell'epatite C cronica (HCV). Lo studio in aperto, condotto negli Stati Uniti e in Canada, confronta questo regime con sofosbuvir e velpatasvir.
Il regime bemnifosbuvir-ruzasvir sarà somministrato una volta al giorno per 8 settimane nei pazienti senza cirrosi e per 12 settimane nei pazienti con cirrosi compensata. Il braccio di controllo dello studio riceverà un trattamento di 12 settimane.
L'azienda mira ad affrontare il significativo onere globale dell'HCV, che colpisce circa 50 milioni di persone in tutto il mondo, con 1 milione di nuove infezioni all'anno. Solo negli Stati Uniti, si stima che 2.4-4 milioni di persone abbiano l'HCV, con nuove infezioni che superano i tassi di trattamento. Il nuovo regime offre potenziali vantaggi tra cui una durata di trattamento più breve, un basso rischio di interazione tra farmaci e nessun requisito alimentare.
Atea Pharmaceuticals (NASDAQ: AVIR) ha iniciado su ensayo de Fase 3 C-BEYOND, administrando al primer paciente para evaluar la combinación de bemnifosbuvir y ruzasvir para el tratamiento del virus de la hepatitis C crónica (HCV). El ensayo abierto, realizado en EE. UU. y Canadá, compara este régimen con sofosbuvir y velpatasvir.
El régimen de bemnifosbuvir-ruzasvir se administrará una vez al día durante 8 semanas en pacientes sin cirrosis y durante 12 semanas en pacientes con cirrosis compensada. El brazo de control del ensayo recibirá un tratamiento de 12 semanas.
La empresa tiene como objetivo abordar la significativa carga global del HCV, que afecta a aproximadamente 50 millones de personas en todo el mundo, con 1 millón de nuevas infecciones anuales. Solo en EE. UU., se estima que entre 2.4 y 4 millones de personas tienen HCV, con nuevas infecciones que superan las tasas de tratamiento. El nuevo régimen ofrece ventajas potenciales, incluyendo una duración de tratamiento más corta, bajo riesgo de interacciones medicamentosas y sin requisitos alimentarios.
Atea Pharmaceuticals (NASDAQ: AVIR)는 만성 C형 간염 바이러스(HCV) 치료를 위해 bemnifosbuvir와 ruzasvir의 조합을 평가하기 위한 3상 시험 C-BEYOND를 시작하고 첫 번째 환자에게 투여했습니다. 미국과 캐나다에서 진행되는 이 공개 시험은 이 요법을 sofosbuvir 및 velpatasvir와 비교합니다.
bemnifosbuvir-ruzasvir 요법은 간경변이 없는 환자에게는 8주 동안, 보상성 간경변이 있는 환자에게는 12주 동안 하루 한 번 투여됩니다. 시험의 대조군은 12주 치료를 받게 됩니다.
회사는 매년 100만 건의 새로운 감염이 발생하는 약 5천만 명의 전 세계 HCV 부담을 해결하는 것을 목표로 하고 있습니다. 미국 내에서만 240만에서 400만 명이 HCV를 앓고 있으며, 새로운 감염이 치료율을 초과하고 있습니다. 새로운 요법은 치료 기간 단축, 낮은 약물 간 상호작용 위험, 식사 효과 요구 없음 등 잠재적인 이점을 제공합니다.
Atea Pharmaceuticals (NASDAQ: AVIR) a lancé son essai de Phase 3 C-BEYOND, administrant le premier patient pour évaluer la combinaison de bemnifosbuvir et ruzasvir dans le traitement du virus de l'hépatite C chronique (HCV). L'essai ouvert, mené aux États-Unis et au Canada, compare ce régime à sofosbuvir et velpatasvir.
Le régime de bemnifosbuvir-ruzasvir sera administré une fois par jour pendant 8 semaines chez les patients sans cirrhose et pendant 12 semaines chez les patients avec cirrhose compensée. Le bras de contrôle de l'essai recevra un traitement de 12 semaines.
La société vise à s'attaquer au fardeau mondial significatif de l'HCV, qui touche environ 50 millions de personnes dans le monde, avec 1 million de nouvelles infections chaque année. Rien qu'aux États-Unis, on estime que 2,4 à 4 millions de personnes ont l'HCV, les nouvelles infections dépassant les taux de traitement. Le nouveau régime offre des avantages potentiels, notamment une durée de traitement plus courte, un faible risque d'interaction médicamenteuse et aucune exigence alimentaire.
Atea Pharmaceuticals (NASDAQ: AVIR) hat seine Phase-3-Studie C-BEYOND gestartet und den ersten Patienten behandelt, um die Kombination von bemnifosbuvir und ruzasvir zur Behandlung des chronischen Hepatitis-C-Virus (HCV) zu bewerten. Die offene Studie, die in den USA und Kanada durchgeführt wird, vergleicht dieses Regime mit sofosbuvir und velpatasvir.
Das bemnifosbuvir-ruzasvir-Regime wird einmal täglich für 8 Wochen bei Patienten ohne Zirrhose und für 12 Wochen bei Patienten mit kompensierter Zirrhose verabreicht. Die Kontrollgruppe der Studie erhält eine 12-wöchige Behandlung.
Das Unternehmen zielt darauf ab, die erhebliche globale HCV-Belastung anzugehen, die schätzungsweise 50 Millionen Menschen weltweit betrifft, mit 1 Million neuen Infektionen jährlich. Allein in den USA wird geschätzt, dass 2,4 bis 4 Millionen Menschen HCV haben, wobei neue Infektionen die Behandlungsraten übersteigen. Das neue Regime bietet potenzielle Vorteile, darunter eine kürzere Behandlungsdauer, ein geringes Risiko von Arzneimittelwechselwirkungen und keine Anforderungen an die Nahrungsaufnahme.
- Phase 3 trial initiation represents significant clinical development milestone
- Potential competitive advantages with shorter 8-week treatment duration for non-cirrhotic patients
- Large addressable market with 50 million patients globally
- Company still in clinical-stage with no approved products
- Faces competition from existing HCV treatments
- Will require significant time and resources to complete Phase 3 trial
Insights
The dosing of the first patient in Atea's Phase 3 C-BEYOND trial represents a significant milestone in the company's HCV development program. This advancement to pivotal studies indicates the treatment regimen has demonstrated sufficient safety and efficacy in earlier phases to justify the substantial investment required for Phase 3 testing.
What stands out about Atea's bemnifosbuvir/ruzasvir combination is the potential for a shorter treatment duration (8 weeks vs standard 12 weeks) for non-cirrhotic patients. This advantage, combined with the low risk for drug-drug interactions and absence of food requirements, addresses key practical barriers that currently limit HCV treatment adherence and completion.
The trial's direct comparison against sofosbuvir/velpatasvir is strategically important, as this establishes a clear benchmark against a current standard therapy. If successful, Atea's regimen could position itself as a preferred option for both treatment-naïve patients and the substantial population of previously diagnosed but untreated individuals.
With HCV infections actually outpacing treatment rates in the US, there remains an urgent need for more accessible and convenient therapies. The market opportunity is substantial with approximately 50 million people globally infected with HCV, including up to 4 million in the US alone.
This Phase 3 initiation strengthens Atea's commercial positioning in the $4-5 billion global HCV market. Despite available treatments, HCV remains significantly undertreated, creating a substantial opportunity for improved therapies that address current barriers to care.
The company's strategic focus on convenience factors (shorter duration, reduced drug interactions, no food effect) targets precisely the challenges that limit current treatment uptake. This is particularly relevant as HCV shifts from specialist care to broader primary care settings, where simplicity and minimal monitoring requirements become competitive advantages.
From a market perspective, HCV's status as the leading cause of liver cancer in major markets (US, Europe, Japan) underscores the significant downstream healthcare costs of untreated infection. Payers are increasingly recognizing that improved treatment accessibility translates to substantial long-term savings by preventing progression to liver failure, cancer, and transplantation.
While Atea will face competition from established therapies, the company's focus on a differentiated profile puts it in position to potentially capture meaningful market share if Phase 3 results confirm their advantages. The trial's design with direct comparison to an established therapy provides a clear pathway to demonstrate superiority on key metrics that matter to clinicians, patients, and payers.
Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect
HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US
New Next-Generation HCV Therapies are Needed to Improve Patient Outcomes
BOSTON, April 09, 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 that the first patient has been dosed in C-BEYOND, Atea’s Phase 3 trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of adults with chronic hepatitis C virus (HCV). C-BEYOND is an open-label trial being conducted in the US and Canada comparing the combination regimen of bemnifosbuvir and ruzasvir to the combination regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir will be administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks.
Despite the availability of direct-acting antivirals, HCV continues to be a significant global health burden. 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.
“Dosing the first patient in our global Phase 3 program is a major advancement as we work to deliver a differentiated, next-generation therapy for HCV,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea. “The unrelenting high rate of HCV infections in the US is outpacing treatment rates and underscores the need for a new therapy that better addresses the current needs of both patients and prescribers. Untreated chronic HCV can have a profound impact on patients’ lives, as well as the associated healthcare hospitalization costs, as the disease progresses. We believe our regimen, which combines key features of short treatment duration, low risk for drug-drug interactions, and convenience with no food effect, if successfully developed, has best-in-class potential and the opportunity to improve patient outcomes and to expand the number of patients treated.”
About the Phase 3 C-BEYOND and C-FORWARD Trials in Adults with Chronic HCV
Atea is conducting two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial will enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials will compare the fixed dose combination (FDC) regimen of bemnifosbuvir and ruzasvir to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir will be administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks for all patients with or without compensated cirrhosis.
The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. While C-BEYOND and C-FORWARD are both open-label trials, Atea has put measures and processes in place that are designed to blind Atea personnel to patient treatment assignments.
The initiation of the Phase 3 program follows a successful engagement with the US Food and Drug Administration (FDA) at an End-of-Phase 2 meeting in January 2025, shortly after the Company announced that its Phase 2 study evaluating the potential best-in-class regimen of bemnifosbuvir and ruzasvir met its primary endpoints of safety and SVR12.
About HCV
HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. A leading cause of chronic liver disease and liver transplants, HCV is mainly spread via blood transfusion, hemodialysis and needle sticks, with 242,000 deaths occurring each year. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
In the US, HCV infections predominate in patients in the age group between 20-49 years old, and it is estimated that fewer than
About Bemnifosbuvir and Ruzasvir for 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 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. In both nonclinical and clinical studies, bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir 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 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 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 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 the development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV and the potential best in class profile of the regimen and the ability of the regimen, if approved, to help improve patient outcomes and to provide opportunities to expand the number of patients treated. 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 regimen of bemnifosbuvir and ruzasvir for the treatment of HCV; 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 Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
barnes.jonae@ateapharma.com
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
FAQ
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