We are cultivating a pipeline of novel, oral drug candidates to treat and prevent viral diseases, with an initial focus on stopping the current coronavirus pandemic (COVID-19) and preventing the next, including on-going evaluation of alternative coronavirus targets and other viral families of interest.
INFORMATION ON PBI-0451
PBI-0451, an investigational Coronavirus Main Protease (Mpro) Inhibitor
Existing COVID-19 treatment options are falling short due to safety concerns, lack of efficacy against new variants, significant drug-drug interactions (DDIs), limited access, and other factors. In non-clinical studies our lead product candidate, PBI-0451, has demonstrated potent antiviral activity against multiple human coronaviruses such as MERS, SARS, OC43 and 229E as well as recent SARS-CoV-2 variants of concern, including those in the Omicron lineage. Data from both non-clinical and Phase 1 clinical trials to date support PBI-0451 as a well-tolerated, stand-alone, ritonavir-free oral regimen. In September 2022, we initiated a Phase 2 clinical trial to evaluate the antiviral activity, safety and efficacy of PBI-0451, and expect to enroll 210 test-positive patients across approximately 75 sites in the United States. Due to its favorable DDI profile, use of concomitant medications for underlying health conditions are not being restricted in this trial. PBI-0451 has the potential to offer simplicity in prescribing, dispensing and administration and change the COVID-19 treatment paradigm globally.
Blocking Replication Before It Begins
Over the last 40 years, significant progress has been made in our understanding of how viruses infect cells, replicate, and spread within the body. We believe a promising method for treating and preventing coronavirus infections is to target the coronavirus Main Protease (Mpro), a highly-conserved protein required for the earliest stages of coronavirus replication. Blocking this target blocks the virus’ ability to replicate. We believe the highly conserved nature of Mpro across multiple coronaviruses, including SARS, MERS, and emerging SARS-CoV-2 variants of concern, supports the potential of this target for both known and potential future coronavirus strains and variants. These insights led to the design of PBI-0451, a coronavirus Mpro inhibitor with demonstrated in vitro activity against multiple strains of coronaviruses. PBI-0451 is currently being evaluated in a Phase 2 clinical trial.