The FDA has granted fast track designation to bemnifosbuvir (Atea Pharmaceuticals). Vemnifosbuvir (Atea Pharmaceuticals) is an investigational oral antiviral for the treatment of her COVID-19 in an outpatient at high risk of disease progression, regardless of vaccination status. This specifically includes patients over the age of 80, those over the age of 65 with at least one of her major risk factors, and those over the age of 18 who are immunocompromised.
The Fast Track Program aims to facilitate the rapid development and review of new drugs or biologics to demonstrate potential to treat serious or life-threatening conditions and to address unmet medical needs. I’m doing it. As part of the designation, Attea Pharmaceuticals may benefit from more frequent communication with FDA and the resulting rolling review of completed sections of new drug applications.
“Grant decision [Fast Track Designation] Dr. Jean-Pierre Sommadossi, CEO and Founder of Atea Pharmaceuticals, said in a press release: “[Fast Track Designation] We look forward to continued discussions with the FDA as it may accelerate the development of bemnifosbuvir. ”
Vemnifosbuvir is a nucleotide polymerase inhibitor that targets the SARS-CoV-2 RNA polymerase. Conserved genes are less likely to change as the virus mutates and new variants emerge. Bemnifosbuvir has a unique mechanism of action with dual targeting of RNA-dependent RNA polymerase (RdRp) and nucleotitytyltransferase (NiRAN), potentially creating a high barrier to resistance.
in vitro The data confirm that bemnifosbuvir is active with similar efficacy against all variants of concern and tested variants of interest, including Omicron subvariants BA.4 and BA.5. It is currently being evaluated in the SUNRISE-3 global multicenter Phase 3 registry trial for the treatment of COVID-19.
The trial is investigating bemnifosbuvir or placebo administered concurrently with locally available standard therapy. Researchers will study at least 1,500 high-risk patients with mild or moderate COVID-19 who were not hospitalized, including patients aged 80 and older, patients aged 65 and older with at least one major risk factor, and immunocompromised patients. We anticipate studies enrolling at-risk patients aged 18 years and older, regardless of COVID-19 vaccination status. Participants were randomized 1:1 to groups in which he received either bemnifosbuvir 550 mg or placebo twice daily, and he received locally available standard of care for 5 days. .
SUNRISE-3 consists of two populations derived from the type of standard therapy received. First, we will evaluate bemnifosbuvir administered as monotherapy in a supportive care population where patients are ineligible for approved oral antiviral therapy or in areas where oral antivirals are not locally available. Second, the combination antiviral population evaluates combination therapy with bemnifosbuvir and standard of care when standard of care includes treatment with other COVID-19 antiviral agents.
The primary endpoint was hospitalization or death from any cause by day 29 in a supportive care population of at least 1,300 patients evaluating bemnifosbuvir as monotherapy. Secondary endpoints in both cohorts included COVID-19 complications, hospital visits, symptom rebound or recurrence, and viral load rebound.
“Given the limitations of current antiviral therapies, including drug-drug interactions, potential risks of genotoxicity and reproductive toxicity, and the ability of the virus to evade vaccines and monoclonal antibodies, new therapeutic options are urgently needed. We are doing it,” said Sommadossi. press release. “With SUNRISE-3, we are targeting the most vulnerable patient populations who are at highest risk of disease progression or death to severe his COVID-19 and who currently have the fewest treatment options.”
reference
Attea Pharmaceuticals announces that Vemnifosbuvir, an investigational oral antiviral agent for the treatment of COVID-19, has been granted Fast Track designation by the US FDA. news release. Atea Pharmaceutical. April 25, 2023. Accessed April 25, 2023. https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-announces-us-fda-fast-track-designation-0
