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March 24, 2021updated 11 Jul 2022 9:51am

Pfizer begins trial of oral antiviral therapeutic agent for Covid-19

Pfizer has initiated a Phase I study of an investigational, novel oral antiviral therapeutic, PF-07321332, for SARS-CoV-2 virus that causes Covid-19, in healthy adult subjects in the US.

Pfizer has initiated a Phase I study of an investigational, novel oral antiviral therapeutic, PF-07321332, for SARS-CoV-2 virus that causes Covid-19, in healthy adult subjects in the US.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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PF-07321332 is a SARS-CoV2-3CL protease inhibitor that showed potent in vitro anti-viral activity against SARS-CoV-2 and other coronaviruses.

The randomised, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adult subjects will analyse the safety, tolerability and pharmacokinetics of PF-07321332.

It is currently progressing to multiple ascending doses after concluding the dosing of single ascending doses.

Pfizer Development and Medical Worldwide Research chief scientific officer and president Mikael Dolsten said: “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care.

“At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients.

“Together, the two have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs.”

In addition, Pfizer is evaluating an intravenously administered investigational protease inhibitor, PF-07304814. This candidate is being analysed in a Phase Ib multi-dose trial in hospitalised Covid-19 patients.

In a separate development, Hong Kong has suspended Covid-19 inoculations using two batches of the Pfizer and BioNTech’s vaccines citing defective packaging, Reuters reported.

The government said manufacturers pointed out that they had no reason to believe safety was at risk and the latest move was just a preventative step.

The news agency quoted the government as saying that it received notice from the vaccine distributor in the financial hub and Macau, Fosun Pharma Industrial (Hong Kong), that packaging defects linked to the closure of bottles were identified in a vaccine batch numbered 210102.

This month, the Israel Ministry of Health (MOH), Pfizer and BioNTech reported real-world evidence showing significantly reduced incidence rates of Covid-19 in fully vaccinated people.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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