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01/24/22 3:20 PM

#241315 RE: DewDiligence #241123

PRDS—Ritonavir-related excerpt from S-1 filing (for registration of insider shares):

In August 2021, we initiated our first-in-human trial for PBI-0451. This trial is anticipated to enroll up to 180 healthy volunteers. The Phase 1 study is a placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy volunteers designed to evaluate the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses.

This study will also evaluate the drug-drug interaction potential of PBI-0451, including upon its coadministration with ritonavir.

Emphasis added.


02/16/22 11:00 AM

#241539 RE: DewDiligence #241123

PRDS is leaning toward a 1400mg daily dose of PBI-0451 (two 350mg tablets BID, taken with food), according to the company’s presentation at CROI this week: (slide #19)

1400mg/day is a lot of drug, even for a short-course regimen.