Tuesday, October 4, 2022


Biotechnology News Magazine

PBI-0451 Ongoing Phase 1 Trial Update from Pardes Biosciences

Presents Interim Clinical Data Supporting the Potential of PBI-0451 as a Stand-Alone Oral Regimen for COVID-19 at Conference on Retroviruses and Opportunistic Infections 2022

PBI-0451 administered twice-daily as a stand-alone agent achieves and maintains PK exposures anticipated to provide potent antiviral activity against SARS-CoV-2. PBI-0451 has been generally well-tolerated and has shown good oral bioavailability.

Pardes Biosciences, Inc. (NASDAQ: 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 29th Conference on Retroviruses and Opportunistic Infections (CROI) 2022.

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 will host a conference call and webcast on Tuesday February 15, at 3:00 p.m. PT / 6:00 p.m. ET to further discuss these results after the CROI late-breaker poster presentation, which is scheduled from 1:00 – 2:30 p.m. PT/ 4:00 -5:30 p.m. ET.

A presentation reviewing the non-clinical and preliminary interim clinical data presented at CROI 2022 can be found on Pardes’ website under “Events and Presentations.”

“We are highly encouraged by these initial Phase 1 observation, which supports 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. Lopatin, M.D., Chief Executive Officer. “COVID-19 continues to take the lives of over 2,000 people a day in the United States alone and disrupts healthcare globally. Additional treatment options with the potential to treat current and emerging variants, such as protease inhibitors, continue to be needed. 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.”

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. All treatment-emergent adverse events in the study reported through January 31, 2022, have been assessed as mild in severity and resolved without intervention.

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.

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.   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.

Conference Call and Webcast Details

Pardes Biosciences will host a conference call and webcast on Tuesday, February 15, 2022, at 3:00 p.m. PT / 6:00 p.m. ET to discuss the interim clinical data. Individuals interested in listening to the event may do so by dialing (855) 427-5533 for domestic callers, or (409) 220-9396 for international callers and reference conference ID: 5686644; or from the webcast link in the investors section of the company’s website at: www.pardesbio.com. The webcast will be available in the investors section on the company’s website for 30 days following the completion of the call.

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