First clinical data from Bemnifosbuvir and Ruzasvir combination shows combination well tolerated in Phase 1 study
Plasma pharmacokinetic (PK) profiles of Bemnifosbuvir and Ruzasvir are not affected by food or coadministration, indicating low risk of drug interactions
Bemnifosbuvir and Ruzasvir are potent direct in vitro antiviral drugs with good antiviral effects against HCV NS5A and NS5B resistance-associated variants (RAV)
BOSTON, Nov. 13, 2023 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea) is a clinical-stage biopharmaceutical company discovering and developing treatments for serious viral diseases oral antiviral therapy, today announced the presentation of two posters at the American Association for the Study of Liver Diseases (AASLD) supporting the combination of the oral nucleotide polymerase inhibitor bemnifosbuvir (bemnifosbuvir) with the oral NS5A inhibitor ruzasvir (ruzasvir) combinations as potential treatments for hepatitis C virus (HCV) The 2023 Liver Conference will be held November 10-14, 2023 in Boston, MA.
“The results from these two studies further support the potential of these two drug candidates combined as novel treatments for HCV. Phase 1 data show that the combination of bemnifosbuvir and ruzasvir is well tolerated and is not affected by food or coadministration impact, indicating a lower risk of drug interactions,” said Dr. Jean-Pierre Sommadossi, CEO and founder of Atea Pharmaceuticals. “and, in vitro Data demonstrate that the combination of bemnifosbuvir and Ruzasvir retains potent, genome-wide antiviral activity against major HCV NS5A and NS5B resistance-associated variants and difficult-to-treat subgenotypes that have been identified in some HCV patients who have failed current treatments . “Available Therapies.”
“We are very pleased with the substantial progress made this year in our Phase 2 combination study of Bemnifosbuvir and Ruzasvir for the treatment of HCV, and we expect to announce results from a 60-person pilot cohort in early 2024,” continued Dr. Somadosi. “We look forward to advancing the clinical development of this potent direct-acting antiviral combination to potentially benefit the millions of patients who remain undertreated despite available HCV treatments.”
Poster number: 1879-A
Date and time: Friday, November 10, 1:00 pm – 2:00 pm
Place: Hall A
title: Lack of pharmacokinetic drug interaction between benifobuvir and ruzavir in healthy subjects
Results from a phase 1 study in 32 healthy adult participants show that the combination of benifobuvir and ruzavir was well tolerated, with plasma pharmacokinetic (PK) profiles generally independent of food or co-administered effects, indicating that there is no drug interaction between the two candidate drugs. Both groups (n = 16) were administered (i) 550 mg bemnifosbuvir once daily from days 7 to 18 for 18 days; ruzasvir 180 mg once daily or (ii) ruzasvir 180 mg once daily for 18 days, beginning on days 7 through 18, benifobuvir 550 mg once daily . No deaths or serious treatment-emergent adverse events (TEAEs) were reported, and no participants withdrew due to TEAEs. These Phase 1 data support the ongoing clinical evaluation of these two potent drug candidates in combination for the treatment of HCV.
Poster number: 1861-A
Date and time: Friday, November 10, 1:00 pm – 2:00 pm
Place: Hall A
title: Bemnifosbuvir and Ruzasvir are potent HCV DAAs with good antiviral properties against the major HCV NS5A and NS5B RAV and support combined use
Results from in vitro Studies have shown that the combination of bemnifosbuvir and ruzasvir has potent, genotype-wide antiviral activity against the major HCV NS5A and NS5B RAV, as well as difficult-to-treat subgenotypes. Furthermore, results showed that bemnifosbuvir was approximately 10 times more potent than sofosbuvir (SOF) and retained full potency against all HCV GT-1a and GT-3a NS5A RAVs tested.Based on these in vitro The results, combined with other data to date, indicate that the combination of bemnifosbuvir and Ruzasvir is expected to retain antiviral activity against the major clinically relevant HCV NS5A and NS5B RAVs. Given the potent, genotype-wide antiviral activity of benifobuvir and ruzasvir, the high resistance barrier of benifobuvir, and the previously reported clinical safety and antiviral activity data for each drug, Benifobuvir is The combination of nifobuvir and ruzasvir may become a promising treatment option for HCV infection. When drug candidates are administered alone, there is a lack of drug interaction between the two drug candidates and their mechanisms of action are complementary.
About hepatitis C virus (HCV)
HCV is a blood-borne, positive-sense, single-stranded RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplantation, and is transmitted through blood transfusions, hemodialysis, and needle sticks. Injection drug use accounts for approximately 60% of all new HCV cases in the United States. Diagnosis of HCV is made through blood tests, including molecular tests, which can detect, quantify and analyze the viral genome and classify the infection into specific viral genotypes. Infection becomes chronic in 75% to 85% of cases, with an incubation period lasting 2 to 26 weeks.
HCV is divided into 7 genotypes and 67 subtypes, with genotype 1 responsible for more than 70% of HCV cases in the United States. HCV patients are also classified according to liver function status: compensated cirrhosis (scarring of the liver) refers to patients whose liver function has not yet been impaired, while decompensated cirrhosis refers to patients whose liver function is moderately to severely impaired.
The number of HCV patients continues to grow dramatically in the United States. Much of the current increase in incidence is due to the opioid crisis, injection drug use, and hepatitis C virus reinfection. The prevalence of hepatitis C in the United States is expected to remain stable in the coming years as rising hepatitis C incidence offsets the number of new patients receiving treatment. The HCV market will have global net sales of approximately $3.5 billion in 2022, approximately 50% of which will come from the United States.
About Bemnifosbuvir and Ruzasvir for the treatment of hepatitis C virus (HCV)
Bemnifosbuvir is an oral nucleotide polymerase inhibitor that has been shown to be approximately 10 times more effective than SOF in vitro A panel of laboratory strains and clinical isolates targeting HCV genotypes 1-5. in vitro Studies have shown that bemnifosbuvir is still fully active against SOF resistance-related strains (S282T), and its potency is 58 times higher than SOF. The PK profile of benifobuvir supports once-daily dosing for the treatment of HCV, and benifobuvir was well tolerated in healthy and HCV-infected subjects at doses up to 550 mg and for up to 8- 12 weeks.
RZR is an oral NS5A inhibitor that has demonstrated potent pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. RZR has been treated in more than 1,200 HCV-infected patients for 12 weeks at daily doses up to 180 mg and demonstrated a favorable safety profile. RZR’s PK profile 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 unmet medical needs in patients with severe viral infections. Leveraging the company’s in-depth understanding of antiviral drug development, nucleos