Additional dose cohorts and PK evaluation in this ongoing Phase 1 study continues and will inform dose selection for the upcoming PBI-0451 Phase 2/3 study anticipated to start mid 2022 (pending regulatory interactions) to evaluate PBI-0451 as a potential treatment of SARS-CoV-2. In multiple ascending dose cohorts, interim data showed that PBI-0451 twice-daily (BID 2 x 350 mg tablets) achieved and maintained PK exposures that the company believes has the potential to provide potent antiviral activity against SARS-CoV-2 and emerging variants. In a drug-drug interaction cohort, the pharmacokinetics of PBI-0451 was not substantially affected when co-administered with ritonavir, a potent P-glycoprotein/CYP450 3A inhibitor. All treatment emergent adverse events in the study reported through Januhave been assessed as mild in severity and resolved without intervention. In the ongoing first in human Phase I trial, PBI-0451 has been observed to be generally well tolerated over a >20-fold single- and >14-fold multiple-total daily dose range. We are excited to continue advancing our lead protease inhibitor PBI-0451 and bring our novel oral antiviral treatment one step closer to patients in need."
Additional treatment options with the potential to treat current and emerging variants, such as protease inhibitors, continue to be needed. "COVID-19 continues to take the lives of over 2,000 people a day in the United States alone and disrupts healthcare globally. "We are highly encouraged by these initial Phase 1 observations, which support continued development of PBI-0451 as a potential stand-alone antiviral therapy for the treatment and prevention of SARS-CoV-2 infections," said Uri A. ET.Ī presentation reviewing the non-clinical and preliminary interim clinical data presented at CROI 2022 can be found on Pardes' website under "Events and Presentations." ET to further discuss these results after the CROI late-breaker poster presentation, which is scheduled from 1:00 – 2:30 p.m. Pardes will host a conference call and webcast on Tuesday February 15, at 3:00 p.m. The presentation entitled, "PBI-0451: An Orally Administered 3CL Protease Inhibitor of SARS-CoV-2 for COVID-19," shared details around the nonclinical profile of PBI-0451 as well as interim clinical safety, tolerability, and pharmacokinetics (PK) after single- and multiple-ascending doses.
#Pardes biosciences trial#
PRDS, a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), announced that interim clinical data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers has been made available to registered conference attendees at the 29 th Conference on Retroviruses and Opportunistic Infections (CROI) 2022. 14, 2022 (GLOBE NEWSWIRE) - Pardes Biosciences, Inc. Company to host conference call and webcast Tuesday, Februat 3:00 p.m.
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