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Atea Pharmaceuticals Presents New Data Supporting the Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir as a Potential Best-in-Class Regimen for Treatment of Hepatitis C Virus Infection at The Liver Meeting® 2025
Globenewswire· 2025-11-07 13:00
Core Insights - Atea Pharmaceuticals presents new modeling data indicating that the combination of bemnifosbuvir (BEM) and ruzasvir (RZR) achieves near-complete inhibition of hepatitis C virus (HCV) replication, with a modeled time to cure of approximately 7 to 8 weeks [1][5] - The Phase 2 study results show sustained virologic response rates (SVR12) of 98% in treatment-adherent patients and 95% overall, reinforcing the regimen's potential as a best-in-class treatment for HCV [1][16] - A virtual KOL panel event is scheduled for November 13, 2025, to discuss the implications of these findings and the ongoing Phase 3 clinical development program [9][10] Phase 2 Study Results - The combination regimen of BEM and RZR demonstrated a high barrier to resistance, with SVR12 rates unaffected by resistance-associated substitutions (RASs) [2][7] - The regimen's efficacy was supported by a resistance analysis indicating that most viral failures were due to treatment non-adherence rather than resistance [7] - The Phase 2 study involved 275 patients, with a notable 98% SVR12 rate in the per-protocol treatment-adherent population [16] Phase 1 Study Findings - A Phase 1 study showed high relative bioavailability of the BEM/RZR fixed-dose combination (FDC) formulation, which can be dosed with or without food [2][8] - The FDC formulation is currently being utilized in the ongoing Phase 3 program, indicating its readiness for broader clinical application [2][11] HCV Market Context - HCV remains a significant public health crisis, with new diagnoses outpacing cure rates despite the availability of direct-acting antiviral therapies [4][15] - An estimated 50 million people are chronically infected with HCV globally, with approximately 240,000 deaths occurring each year [13][15] - The need for optimized treatment options is critical, especially for patients with co-infections or those on concomitant medications [4][3] Upcoming Events - Atea will host a virtual investor event featuring leading HCV clinical experts to discuss current challenges in HCV treatment and the potential benefits of next-generation therapies [9][10] - The event will provide insights into the HCV commercial market opportunity and updates on the ongoing global Phase 3 clinical development program [10][11]
Atea Pharmaceuticals Announces Full Results from Phase 2 Study of Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus (HCV) Presented at EASL Congress 2025
Globenewswire· 2025-05-07 11:00
Core Insights - Atea Pharmaceuticals presented results from its Phase 2 study of bemnifosbuvir (BEM) and ruzasvir (RZR) for hepatitis C treatment, achieving a 98% sustained virologic response rate at 12 weeks post-treatment with an 8-week regimen [2][5][8] - The study demonstrated the regimen's safety, low risk of drug-drug interactions, and effectiveness in patients with hepatic or renal impairment [3][9][12] Phase 2 Study Results - The Phase 2 study included 275 patients, showing a 98% SVR12 in treatment-adherent patients and 95% in all patients regardless of adherence [2][8] - Among patients with compensated cirrhosis, the SVR12 rate was 88%, with all achieving undetectable viral levels by the end of the 8-week treatment [6][8] Safety and Tolerability - The combination of BEM and RZR was generally safe and well-tolerated, with treatment-emergent adverse events reported in 43% of patients, mostly mild to moderate [8] - No serious adverse events or treatment discontinuations were linked to the study drugs [8] Drug-Drug Interaction Studies - Phase 1 studies indicated a low risk of drug-drug interactions when BEM/RZR was co-administered with standard HIV treatments [3][10] - BEM was found to be safe for patients with hepatic and renal impairments without the need for dose adjustments [9][12] Future Developments - Atea plans to conduct two Phase 3 trials, C-BEYOND and C-FORWARD, to further evaluate the BEM/RZR regimen against existing treatments [16][18] - The primary endpoint for these trials is achieving HCV RNA levels below the lower limit of quantitation at 24 weeks [17] Market Context - An estimated 2.4 to 4.0 million people in the US are living with chronic HCV, with a significant portion also taking concomitant medications [7][15] - The ongoing need for effective HCV treatments is underscored by the fact that annual diagnoses outpace cure rates [7][15]