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Four late-stage COVID-19 vaccine trial protocols harmonized, Fauci says

Plus Regeneron and NIAID start Phase III prevention trial of antiviral mAb cocktail

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In a live-streamed conversation, NIH director Francis Collins and NIAID director Anthony Fauci discussed progress in standardizing protocols of Phase III trials for COVID-19 vaccines, as well as the ongoing need for therapies that can treat patients after infection.

Applying the same protocols and endpoints across COVID-19 clinical trials would help ensure quality standards and greatly facilitate comparison of results.

FDA’s COVID-19 guidance, released June 30, laid the groundwork for robust, randomized, placebo-controlled trials but left it up to groups such as NIH and Operation Warp Speed to encourage developers to coordinate and harmonize clinical trial endpoints and assays (see “FDA’s COVID-19 Vaccine Guidance Hits Mark”).

In the conversation between Collins and Fauci, which aired Monday on Twitter and Facebook, Fauci noted that at least four vaccines are slated to begin late-stage trials between July and October, and that the trial protocols have been harmonized and will include the same endpoints.

While Fauci did not name the vaccine candidates, they likely include three vaccine front-runners supported by Operation Warp Speed: BNT162 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX, mRNA-1273 from Moderna Inc. (NASDAQ:MRNA) and NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and INO-4800 from Inovio Pharmaceuticals Inc. (NASDAQ:INO).

Operation Warp Speed is supported by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium, a public-private partnership led by NIH and managed by the Foundation for NIH (see “Global Access to COVID-19 Vaccines”).

Separate 30,000-person Phase III studies of BNT162 and mRNA-1273 could start in July. Inovio plans to launch a Phase II/III study of INO-4800 this summer.

Phase II/III enrollment in the U.K. for a fourth Warp Speed candidate, AZD1222 from AstraZeneca plc (LSE:AZN; NYSE:AZN), has already begun.

COVID-19 therapeutics

Fauci and Collins also noted that vaccines against SARS-CoV-2 won’t be enough. COVID-19 countermeasures also need to include therapies that can treat the disease (see “More Than One Way to Tame a Virus”).

While remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) and the anti-inflammatory steroid dexamethasone have both shown some benefit patients with advanced COVID-19, therapies that can address early stages of COVID-19 are still needed, Fauci said. He highlighted several therapeutic classes that could fill that niche, including virus-targeting mAbs.

ACTIV is developing five separate master protocols for evaluating different classes of COVID-19 therapeutics. Two of the trials, ACTIV 2 and ACTIV 3, will test antiviral neutralizing mAbs in outpatient and hospital settings (see “ACTIV Coming into Focus”).

Antiviral mAbs also have potential to serve as preventative therapies while vaccine efficacy is still under evaluation, and NIAID and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are jointly running a Phase III trial of the company’s COVID-19 antiviral mAb cocktail as post-exposure prophylaxis.

Regeneron separately announced on Monday positive safety readouts from the Phase I portions of two adaptive Phase I/II/III studies evaluating REGN-COV2 to treat hospitalized and non-hospitalized COVID-19 patients.

The analysis by an independent data monitoring board has enabled the company to advance the antiviral mAb cocktail into the Phase II/III portions of the studies, which began in June, as well as begin the partnered preventative trial (see “Regeneron Pushes mAb Cocktail into Clinic”).

Regeneron and NIAID expect to enroll in the prophylaxis trial about 2,000 people in the U.S. who are household contacts of SARS-CoV-2-positive individuals. The primary efficacy endpoints are the total percentage of patients who become SARS-CoV-2-positive by one month, and the proportion of patients who become positive for the virus and develop symptoms.

The treatment trials, which are evaluating IV REGN-COV2, are expected to enroll about 1,850 hospitalized COVID-19 patients and about 1,050 non-hospitalized COVID-19 patients in the U.S., Brazil, Mexico and Chile; and will assess virologic and clinical endpoints. Preliminary data are expected this summer.

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