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NIH-led ACTIV partnership close to selecting repurposed therapies for COVID-19 trials

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The Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership is close to selecting a handful of therapies to test in one or more large-scale master protocols, NIH Director Francis Collins said Tuesday.

Collins also expressed optimism about the potential effectiveness of mAbs and said trial results could be available this summer.

ACTIV’s therapeutics working group narrowed down a list of hundreds of proposed therapeutic agents that have already been in clinical trials to about six priority candidates, Collins reported in an interview with JAMA. The candidates include immunomodulators and supportive therapies.

The working group presented ACTIV’s executive committee with the list on May 6, ACTIV co-chairs Collins and Paul Stoffels, vice chairman of the executive committee and CSO of Johnson & Johnson (NYSE:JNJ), wrote in a recent commentary about the partnership.

The executive committee will debate the proposal Wednesday afternoon, and if it agrees with the proposal, one or more large-scale master protocols to test their safety and efficacy will be started quickly, Collins said.

ACTIV’s goal is to launch a master protocol less than six weeks after its executive committee approves the prioritized list, Collins said.

Trial sites will be “geo-mapped” to coincide with regions with active COVID-19 outbreaks.

ACTIV, which is coordinated by the Foundation for the NIH (FNIH), brings together 18 biopharmaceutical companies; U.S. government agencies, including NIH and FDA; and academic scientists.

ACTIV executive committee members are Mikael Dolsten, CSO of Pfizer Inc. (NYSE:PFE); Anthony Fauci, director of NIH’s National Institute for Allergy and Infectious Diseases; Gary Gibbons, director of NIH’s National Heart, Lung, and Blood Institute; William Pao, head of pharma research and early development at Roche (SIX:ROG; OTCQX:RHHBY); and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

The first set of therapeutic candidates will be targeted at helping hospitalized COVID-19 patients, Collins said.

In addition to the master protocol for therapeutics, ACTIV is designing two master protocols for COVID-19 mAbs, one for outpatient use and another for hospitalized patients, Collins said.

More than a dozen companies are developing mAbs for COVID-19, Collins said. Three companies have announced that they’ll be ready to start trials soon: Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Vir Biotechnology Inc. (NASDAQ:VIR) and AbCellera Biologics Inc.

Collins did not say which of these companies will participate in ACTIV’s master protocol, but he expressed confidence that they will harmonize endpoints and trial designs so results can be easily compared.

Collins expressed cautious optimism about mAbs, saying that large effect sizes are expected, which could minimize the number of patients that need to be enrolled in trials. Results from the first trials could be ready in August, he said.

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