Atea Pharmaceuticals Provides Update on Global Phase 3 SUNRISE-3 Trial Evaluating Bemnifosbuvir for Treatment of COVID-19
Atea Pharmaceuticals (Nasdaq: AVIR) announced that its global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for COVID-19 treatment did not meet its primary endpoint. The trial, involving 2,221 high-risk patients with mild to moderate COVID-19, failed to show a statistically significant reduction in all-cause hospitalization or death through Day 29 compared to placebo. Despite the disappointing outcome, bemnifosbuvir was generally safe and well-tolerated.
The company attributed the trial's failure to the evolving nature of COVID-19 variants and the trend towards milder disease, resulting in fewer hospitalizations and deaths. Notably, severe respiratory disease caused by COVID was not observed in SUNRISE-3, unlike in previous studies. Atea will not pursue a regulatory pathway for bemnifosbuvir in COVID-19 treatment but remains focused on developing a combination of bemnifosbuvir and ruzasvir for hepatitis C treatment.
Atea Pharmaceuticals (Nasdaq: AVIR) ha annunciato che il suo trial globale di Fase 3 SUNRISE-3 per valutare bemnifosbuvir nel trattamento del COVID-19 non ha raggiunto l'obiettivo primario. Lo studio, che ha coinvolto 2.221 pazienti ad alto rischio con COVID-19 lieve o moderato, non ha mostrato una riduzione statisticamente significativa nelle ospedalizzazioni o nei decessi totali entro il Giorno 29 rispetto al placebo. Nonostante l'esito deludente, il bemnifosbuvir è stato generalmente sicuro e ben tollerato.
L'azienda ha attribuito il fallimento dello studio alla natura in evoluzione delle varianti del COVID-19 e alla tendenza verso forme più lievi della malattia, che hanno portato a un minor numero di ospedalizzazioni e decessi. È importante notare che nessun grave problema respiratorio causato dal COVID è stato osservato nello studio SUNRISE-3, a differenza di studi precedenti. Atea non perseguirà un percorso regolatorio per il bemnifosbuvir nel trattamento del COVID-19, ma rimane concentrata sullo sviluppo di una combinazione di bemnifosbuvir e ruzasvir per il trattamento dell'epatite C.
Atea Pharmaceuticals (Nasdaq: AVIR) anunció que su ensayo global de Fase 3 SUNRISE-3, que evalúa bemnifosbuvir para el tratamiento del COVID-19, no cumplió con su objetivo principal. El ensayo, que involucró a 2,221 pacientes de alto riesgo con COVID-19 leve a moderado, no mostró una reducción estadísticamente significativa en las hospitalizaciones o muertes por todas las causas hasta el Día 29 en comparación con el placebo. A pesar del resultado decepcionante, el bemnifosbuvir fue generalmente seguro y bien tolerado.
La empresa atribuyó el fracaso del ensayo a la naturaleza cambiante de las variantes de COVID-19 y a la tendencia hacia enfermedades más leves, lo que resultó en menos hospitalizaciones y muertes. Es notable que no se observó enfermedad respiratoria severa causada por COVID en SUNRISE-3, a diferencia de estudios anteriores. Atea no buscará una vía regulatoria para el bemnifosbuvir en el tratamiento del COVID-19, pero se concentra en desarrollar una combinación de bemnifosbuvir y ruzasvir para el tratamiento de la hepatitis C.
Atea Pharmaceuticals (Nasdaq: AVIR)는 COVID-19 치료를 위한 bemnifosbuvir를 평가하는 글로벌 3상 시험 SUNRISE-3가 주요 목표를 달성하지 못했다고 발표했습니다. 이 시험은 경증에서 중등증 COVID-19 환자 2,221명을 대상으로 진행되었으며, 위약 대비 29일차까지 모든 원인에 의한 입원 및 사망의 통계적으로 유의미한 감소를 보여주지 못했습니다. 실망스러운 결과에도 불구하고, bemnifosbuvir는 일반적으로 안전하고 잘 견뎌졌습니다.
회사는 시험의 실패를 COVID-19 변종의 진화하는 특성과 더 가벼운 질병으로의 경향에 기인한다고 설명했습니다. 이로 인해 입원 및 사망이 줄어들었습니다. 또한, SUNRISE-3에서 COVID로 인한 중증 호흡기 질환은 관찰되지 않았습니다. 이는 이전 연구와는 다릅니다. Atea는 COVID-19 치료를 위한 bemnifosbuvir의 규제 경로를 추구하지 않을 것이며, C형 간염 치료를 위한 bemnifosbuvir와 ruzasvir의 조합 개발에 집중할 것입니다.
Atea Pharmaceuticals (Nasdaq: AVIR) a annoncé que son essai mondial de phase 3 SUNRISE-3 évaluant bemnifosbuvir pour le traitement du COVID-19 n'a pas atteint son objectif principal. L'essai, impliquant 2 221 patients à haut risque atteints de COVID-19 léger à modéré, n'a pas montré de réduction statistiquement significative des hospitalisations ou des décès toutes causes confondues jusqu'au jour 29 par rapport au groupe placebo. Malgré ce résultat décevant, le bemnifosbuvir a été généralement jugé sûr et bien toléré.
L'entreprise a attribué l'échec de l'essai à la nature évolutive des variantes du COVID-19 et à la tendance vers des maladies plus légères, entraînant moins d'hospitalisations et de décès. Il convient de noter qu'aucune maladie respiratoire sévère causée par le COVID n'a été observée dans SUNRISE-3, contrairement aux études précédentes. Atea ne poursuivra pas de voies réglementaires pour le bemnifosbuvir dans le traitement du COVID-19, mais se concentre sur le développement d'une combinaison de bemnifosbuvir et de ruzasvir pour le traitement de l'hépatite C.
Atea Pharmaceuticals (Nasdaq: AVIR) gab bekannt, dass die globale Phase-3-Studie SUNRISE-3 zur Bewertung von bemnifosbuvir bei der Behandlung von COVID-19 ihr primäres Ziel nicht erreicht hat. In der Studie, an der 2.221 Hochrisikopatienten mit mildem bis moderatem COVID-19 teilnahmen, konnte im Vergleich zur Placebogruppe bis Tag 29 keine statistisch signifikante Reduktion der Krankenhausaufenthalte oder Todesfälle festgestellt werden. Trotz des enttäuschenden Ergebnisses war bemnifosbuvir im Allgemeinen sicher und gut verträglich.
Das Unternehmen führte das Scheitern der Studie auf die sich entwickelnde Natur der COVID-19-Varianten sowie auf den Trend zu milderen Krankheitsverläufen zurück, was zu weniger Krankenhausaufenthalten und Todesfällen führte. Es ist bemerkenswert, dass in SUNRISE-3 keine schweren Atemwegserkrankungen durch COVID beobachtet wurden, im Gegensatz zu früheren Studien. Atea wird keinen regulatorischen Weg für bemnifosbuvir zur Behandlung von COVID-19 verfolgen, sondern konzentriert sich auf die Entwicklung einer Kombination aus bemnifosbuvir und ruzasvir zur Behandlung von Hepatitis C.
- Bemnifosbuvir was generally safe and well-tolerated in the trial
- Atea remains focused on developing bemnifosbuvir and ruzasvir combination for hepatitis C treatment
- Additional results from the Phase 2 hepatitis C trial expected in Q4 2024
- SUNRISE-3 trial failed to meet primary endpoint for COVID-19 treatment
- No statistically significant reduction in all-cause hospitalization or death through Day 29
- Company will not pursue regulatory pathway for bemnifosbuvir in COVID-19 treatment
The failure of bemnifosbuvir to meet its primary endpoint in the SUNRISE-3 trial is a significant setback for Atea Pharmaceuticals. This outcome highlights the challenges in developing effective COVID-19 treatments as the virus evolves. Key points:
- The trial involved a large cohort of 2,221 high-risk patients, which lends credibility to the results.
- The absence of severe respiratory disease cases in this trial, compared to previous studies, suggests a shift in COVID-19's clinical presentation.
- This evolution makes it harder for direct-acting antivirals to demonstrate efficacy, potentially impacting future drug development strategies.
While disappointing, these results contribute valuable data to our understanding of COVID-19's progression and treatment challenges.
This news is likely to have a negative impact on Atea Pharmaceuticals' stock in the short term. Key financial implications:
- The failure of SUNRISE-3 eliminates a potential revenue stream from COVID-19 treatment.
- Atea will likely redirect resources to its hepatitis C program, focusing on the bemnifosbuvir and ruzasvir combination.
- Investors may reassess Atea's pipeline value, potentially leading to a market capitalization adjustment.
However, the company's
The SUNRISE-3 trial results reflect broader trends in the COVID-19 therapeutics market:
- Evolving virus variants and milder disease presentations are changing the landscape for antiviral development.
- There's a potential shift in market demand towards treatments for long COVID or prevention strategies.
- The challenges faced by Atea may impact investor sentiment towards other companies developing COVID-19 antivirals.
This outcome underscores the need for adaptable research strategies in the face of rapidly evolving infectious diseases. Companies with diverse pipelines beyond COVID-19 may be better positioned in this changing market environment.
BOSTON, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated.
“We are disappointed by the outcome of the SUNRISE-3 trial. Variants of COVID-19 are constantly evolving and the natural history of the disease trended toward milder disease, which has resulted in fewer hospitalizations and deaths. In particular, hospitalization due to severe respiratory disease caused by COVID was not observed in SUNRISE-3, in contrast to our prior study. In an environment where there is much less COVID-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate impact on the course of the disease,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “I am proud of our team’s rigorous execution of this trial in a constantly changing pandemic environment.”
“We want to thank the study participants and investigators who made this important research possible. While we are disappointed with the outcome of trial and will not pursue a regulatory pathway forward, we believe that the findings add to the collective understanding of the evolution of COVID-19,” added Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals.
Atea remains focused on the development of the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C. The company plans to announce additional results from the Phase 2 trial in the fourth quarter of 2024.
About the Phase 3 SUNRISE-3 Trial in High-Risk Outpatients with COVID-19
The global, multicenter, randomized, double-blind, placebo-controlled Phase 3 SUNRISE-3 trial evaluated bemnifosbuvir or placebo administered concurrently with the locally available standard of care (SOC). SUNRISE-3 exclusively 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 primary endpoint of the SUNRISE-3 trial was all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort. In addition, secondary endpoints measured patient outcomes in the trial through Day 60 post-treatment.
About Bemnifosbuvir
Derived from our internal discovery program, bemnifosbuvir, is an investigational, novel, orally administered guanosine nucleotide analog polymerase inhibitor that combines a unique nucleotide scaffold with novel double prodrugs for the intended purpose of inhibiting the enzymes central to viral replication. We believe that utilizing this double prodrug moiety approach allows us to maximize formation of the active metabolite potentially resulting in an oral antiviral product candidate that is selective for and highly effective at preventing replication and transcription of single stranded RNA (“ssRNA”) viruses while avoiding toxicity to host cells.
Bemnifosbuvir is in Phase 2 development in combination with ruzasvir, an oral NS5A inhibitor, for the treatment of hepatitis c virus (HCV) infection. Bemnifosbuvir has a low risk of drug-drug interactions, and has a generally safe and well-tolerated profile, with a distinct mechanism of action and a high barrier to treatment resistance.
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. 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 anticipated timing of results from Atea’s Phase 2 trial of the combination of bemnifosbuvir and ruzasvir in the treatment of hepatitis C. 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, 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 June 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 Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com
Will O’Connor
Precision AQ
212-362-1200
will.oconnor@precisionaq.com
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