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Topline Phase 3 Results from C-FORWARD Expected Around Year-End 2026
More Than 880 HCV Treatment-Naïve Patients Enrolled Across 17 Countries Outside North America
C-FORWARD and C-BEYOND Represent the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for the Treatment of HCV
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced completion of patient enrollment in C-FORWARD, its Phase 3 clinical trial outside North America, evaluating the regimen of bemnifosbuvir and ruzasvir (BEMRZR) for the treatment of hepatitis C virus (HCV) infection. The anticipated topline results from C-BEYOND, the Phase 3 trial conducted in the US and Canada, remain on track for mid-year 2026.
C-FORWARD enrolled more than 880 treatment-naïve patients across approximately 120 clinical sites in 17 countries. The trial is evaluating the fixed-dose combination regimen of BEM/RZR against a current standard of care – the fixed-dose combination regimen of sofosbuvir and velpatasvir – in patients with chronic HCV infection. Topline results from C-FORWARD are expected around year-end 2026. Notably, patients enrolled in C-FORWARD have a diverse range of HCV genotypes, including genotypes more commonly observed outside North America, supporting the potential for a broad treatment label.
"Completion of enrollment in C-FORWARD marks another significant milestone for our global Phase 3 HCV program as we look ahead to topline results mid-year from C-BEYOND, our North American trial," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "These studies represent the first global Phase 3 program with head-to-head trials of direct-acting antivirals for HCV and underscore our commitment to advancing a potentially best-in-class regimen. We believe the target profile of the regimen of BEM/RZR, featuring short treatment duration, low risk of drug-drug interactions and convenience with no food effect, if successfully developed, will uniquely position us to address the evolving needs of today's patients and bring us closer to the ultimate goal of HCV eradication."
Despite the availability of direct-acting antivirals (DAAs), HCV remains a significant global public health challenge with an estimated over 50 million people living with chronic infection worldwide, including up to four million people in the US. In the US, HCV diagnoses continue to outpace annual cure rates. Untreated HCV can lead to serious liver complications, including cirrhosis, liver failure and hepatocellular carcinoma. Atea's HCV program aims to meaningfully advance the standard of care by delivering a best-in-class regimen for the treatment of patients worldwide.
About the C-FORWARD Phase 3 Trial
C-FORWARD is a randomized, open-label Phase 3 trial evaluating the safety and efficacy of the fixed-dose combination regimen of BEM/RZR in treatment-naïve patients with chronic HCV infection outside North America. The trial enrolled more than 880 patients in 17 countries.
The regimen of BEM/RZR is being administered once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is being administered once-daily for 12 weeks to all patients, regardless of cirrhosis status.
The primary endpoint for the C-FORWARD 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 measurement occurs at the same relative timepoint from the start of treatment in all patients. The primary endpoint will be assessed in the per-protocol population in C-FORWARD.
About Bemnifosbuvir and Ruzasvir for HCV
Bemnifosbuvir 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 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 of drug-drug interactions. Bemnifosbuvir has been administered to over 3,000 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 2,800 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 HCV
HCV is a blood-borne, 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 approximately 240,000 deaths occurring each year. Despite the availability of DAAs, 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, up to four 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 and 49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is a leading cause of liver cancer in the US, Europe and Japan.
About Atea Pharmaceuticals
Atea is a late-stage clinical 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. Atea's Phase 3 program is evaluating the fixed-dose combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. Atea anticipates initiating clinical development of AT-587, a nucleotide analog, for the treatment of hepatitis E virus (HEV) in mid-2026. 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 potential best-in-class profile of the regimen of BEM/RZR for the treatment of HCV, anticipated milestone events and timelines for clinical trials including the timeline for readout of the HCV Phase 3 clinical trials results and initiation of the HEV clinical development, future results of operations and business strategy. 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, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; dependence on the success of Atea's most advanced product candidates, in particular the BEM/RZR regimen for the treatment of HCV; 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 March 31, 2026 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
