Atea Pharmaceuticals to Highlight 2025 Strategic Priorities at the 43rd Annual J.P. Morgan Healthcare Conference
Atea Pharmaceuticals (AVIR) announces strategic priorities for 2025, focusing on its global Phase 3 program for HCV treatment. The company plans to initiate trials for its bemnifosbuvir and ruzasvir regimen in Q1 2025, targeting a $3 billion global HCV market.
The company reports $454.7 million in cash and equivalents as of December 31, 2024, with runway extending into 2028. The Phase 3 program will include two open-label trials, each enrolling up to 800 treatment-naïve HCV patients. The trials will evaluate 8-week treatment for non-cirrhotic patients and 12-week treatment for cirrhotic patients, compared to sofosbuvir/velpatasvir.
Market research indicates strong healthcare provider interest in prescribing the regimen and positive payor receptiveness. The treatment aims to address the significant global HCV burden, affecting an estimated 50 million people worldwide with approximately one million new infections annually.
Atea Pharmaceuticals (AVIR) annuncia le priorità strategiche per il 2025, concentrandosi sul suo programma globale di Fase 3 per il trattamento dell'HCV. L'azienda prevede di avviare le sperimentazioni per il suo regime di bemnifosbuvir e ruzasvir nel primo trimestre del 2025, mirando a un mercato globale dell'HCV di $3 miliardi.
L'azienda riporta $454,7 milioni in contante e equivalenti al 31 dicembre 2024, con una disponibilità estesa fino al 2028. Il programma di Fase 3 comprenderà due studi aperti, ciascuno con un massimo di 800 pazienti HCV naive al trattamento. Gli studi valuteranno un trattamento di 8 settimane per pazienti non cirrotici e un trattamento di 12 settimane per pazienti cirrotici, confrontato con sofosbuvir/velpatasvir.
Le ricerche di mercato indicano un forte interesse da parte dei fornitori di servizi sanitari nella prescrizione del regime e una reattività positiva da parte dei pagatori. Il trattamento mira ad affrontare l'importante onere globale dell'HCV, che colpisce circa 50 milioni di persone in tutto il mondo, con circa un milione di nuove infezioni annuali.
Atea Pharmaceuticals (AVIR) anuncia sus prioridades estratégicas para 2025, centrándose en su programa global de Fase 3 para el tratamiento de la HCV. La compañía planea iniciar ensayos para su régimen de bemnifosbuvir y ruzasvir en el primer trimestre de 2025, con el objetivo de un mercado global de HCV de $3 mil millones.
La compañía informa de $454.7 millones en efectivo y equivalentes a partir del 31 de diciembre de 2024, con un horizonte que se extiende hasta 2028. El programa de Fase 3 incluirá dos ensayos abiertos, cada uno inscribiendo hasta 800 pacientes de HCV que nunca han recibido tratamiento. Los ensayos evaluarán un tratamiento de 8 semanas para pacientes no cirróticos y un tratamiento de 12 semanas para pacientes cirróticos, en comparación con sofosbuvir/velpatasvir.
Las investigaciones de mercado indican un fuerte interés por parte de los proveedores de salud en prescribir el régimen y una receptividad positiva de los pagadores. El tratamiento tiene como objetivo abordar la significativa carga global de HCV, que afecta a aproximadamente 50 millones de personas en todo el mundo, con aproximadamente un millón de nuevas infecciones anualmente.
Atea Pharmaceuticals (AVIR)는 2025년을 위한 전략적 우선사항을 발표하며 HCV 치료를 위한 글로벌 3상 프로그램에 집중합니다. 이 회사는 2025년 1분기에 bemnifosbuvir와 ruzasvir 치료 요법에 대한 시험을 시작할 계획이며, 30억 달러 규모의 글로벌 HCV 시장을 타겟으로 하고 있습니다.
회사는 2024년 12월 31일 기준으로 4억 5천 470만 달러의 현금 및 현금 équivalents를 보유하고 있으며, 자금이 2028년까지 이어질 것으로 기대하고 있습니다. 3상 프로그램은 각 시험에 최대 800명의 HCV 치료 이력이 없는 환자를 등록하는 두 개의 공개 시험을 포함할 것입니다. 이 시험들은 비간경변 환자에 대해 8주 치료와 간경변 환자에 대해 12주 치료를 평가하며, sofosbuvir/velpatasvir와 비교됩니다.
시장 조사는 의료 제공자들이 이 요법을 처방하는 데 강한 관심을 보이고 있으며, 지불자의 수용도 긍정적임을 나타냅니다. 이 치료는 전 세계적으로 약 5천만 명의 사람들에게 영향을 미치는 HCV의 상당한 부담을 해결하는 것을 목표로 하며, 매년 약 100만 건의 새로운 감염이 발생하고 있습니다.
Atea Pharmaceuticals (AVIR) annonce ses priorités stratégiques pour 2025, en se concentrant sur son programme mondial de phase 3 pour le traitement du VHC. L'entreprise prévoit de commencer des essais pour son régime de bemnifosbuvir et ruzasvir au premier trimestre 2025, visant un marché mondial du VHC de 3 milliards de dollars.
L'entreprise rapporte 454,7 millions de dollars en liquidités et équivalents au 31 décembre 2024, avec une durée de financement s'étendant jusqu'en 2028. Le programme de phase 3 comprendra deux essais ouverts, chacun recrutant jusqu'à 800 patients HCV naïfs de traitement. Les essais évalueront un traitement de 8 semaines pour les patients non cirrhotiques et un traitement de 12 semaines pour les patients cirrhotiques, comparé à sofosbuvir/velpatasvir.
Les recherches de marché indiquent un fort intérêt des prestataires de soins de santé pour prescrire le régime et une réceptivité positive des payeurs. Le traitement vise à s'attaquer au fardeau mondial significatif du VHC, touchant environ 50 millions de personnes dans le monde, avec environ un million de nouvelles infections chaque année.
Atea Pharmaceuticals (AVIR) gibt strategische Prioritäten für 2025 bekannt, wobei der Schwerpunkt auf seinem globalen Phase-3-Programm zur Behandlung von HCV liegt. Das Unternehmen plant, im ersten Quartal 2025 Tests für sein Regime aus bemnifosbuvir und ruzasvir zu starten, mit dem Ziel eines globalen HCV-Marktes von 3 Milliarden US-Dollar.
Das Unternehmen berichtet zum 31. Dezember 2024 von 454,7 Millionen US-Dollar in Bargeld und Äquivalenten und von einer Finanzierungsdauer bis 2028. Das Phase-3-Programm wird zwei offene Studien umfassen, in denen jeweils bis zu 800 behandlungsnaive HCV-Patienten rekrutiert werden. Die Studien werden eine 8-wöchige Behandlung für nicht-zirrhotische Patienten und eine 12-wöchige Behandlung für zirrhotische Patienten evaluieren, verglichen mit sofosbuvir/velpatasvir.
Marktforschung zeigt ein starkes Interesse der Gesundheitsdienstleister an der Verordnung des Regimes und eine positive Bereitschaft der Kostenträger. Die Behandlung zielt darauf ab, die erhebliche globale HCV-Belastung anzugehen, die schätzungsweise 50 Millionen Menschen weltweit betrifft, mit etwa einer Million neuer Infektionen jährlich.
- Strong cash position of $454.7 million with runway into 2028
- Phase 2 study met primary endpoints for HCV treatment
- Targeting $3 billion global HCV market opportunity
- Positive market research feedback from healthcare providers and payors
- Shorter treatment duration (8 weeks) for non-cirrhotic patients compared to standard 12 weeks
- None.
Insights
The initiation of a global Phase 3 program for HCV treatment represents a major milestone for Atea Pharmaceuticals. The combination of bemnifosbuvir and ruzasvir shows potential advantages over existing treatments, including shorter treatment duration for non-cirrhotic patients (8 weeks vs standard 12 weeks) and a simplified dosing profile with no food restrictions.
The Phase 3 program's design with 1,600 patients across two trials is robust and well-powered. The company's strong cash position of
The target market opportunity is substantial, with the global HCV market generating
Recent market research indicates strong commercial potential for this HCV regimen. Healthcare provider receptivity and positive payor feedback regarding formulary inclusion are important early indicators of commercial viability. The drug's profile addresses key market needs: simplified dosing, shorter treatment duration and minimal drug interactions.
The HCV market dynamics are particularly favorable - while existing treatments are available, infection rates are outpacing treatment rates in the US. This creates an opportunity for new entrants with superior profiles to capture significant market share. The company's targeted positioning as a potential best-in-class treatment could drive rapid adoption, especially given the large untreated patient population of 2.4-4 million in the US alone.
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
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
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
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
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
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
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 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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1 Atea Custom Research, PharmaValue Partners 2023 and Atea Custom Research, Formulary Insights 2024
FAQ
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