FDA Backs New Effort to Repurpose Drugs As COVID-19 Treatments

FDA is teaming up with the Critical Path Institute and National Center for Advancing Translational Sciences (NCATS) to launch the CURE Drug Repurposing Collaboratory (CDRC) to evaluate existing drugs that show promise as COVID-19 treatments, according to a press release. 

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CDRC is a public-private partnership initiated earlier this month that leverages real-world data collected through the CURE ID platform to boost drug repurposing and inform future clinical trials for diseases of high unmet medical need. 

The CURE ID is an FDA-NCATS collaboration to build an internet-based repository that allows the global clinical community to report novel uses of existing drugs to treat diseases through a website, a smartphone, or other mobile devices, the release stated.

The repository receives the clinical outcomes when drugs are used for new indications, in new populations, in new doses, or in new combinations.

The release also noted that the CDRC includes emerging and reemerging diseases, anti-microbial drug resistant infections, neglected infectious diseases, and rare oncology diseases where there are limited treatment options.

“CDRC’s pilot project focuses on COVID-19. With no approved therapy available, the SARS-CoV-2 pandemic has led clinicians to treat patients with off-label drugs and/or different drug combinations, doses and regimens. Gathering much-needed data from clinicians about their COVID-19 patients’ medical outcomes can generate vast amounts of data on a global scale.” the release said.

“To address this need, the CURE ID platform will be used to capture individual case reports and serve as the single centralized source of reliable curated publicly available information for COVID-19. The platform will be coordinating with the FDA Adverse Event Reporting System (FAERS) to collect both safety and efficacy data so health care providers do not need to submit duplicate reports.”

Many organizations are participating in CDRC, including global stakeholders, clinicians, scientists, HHS agencies, non-government organizations, foundations, and societies. 

Critical Path Institute noted five ways in which the organizations will help to advance CDRC, including to:

• Promote the CURE ID platform to enable the global health community to openly share patient treatment outcomes
• Evaluate drug leads through advanced analytics to identify candidates for repurposing as new treatments in a transparent open forum
• Inform the design of clinical trials of existing marketed drugs for new indications
• Generate real-world evidence for expanding drug labels
• Provide a regulatory roadmap to advance drug repurposing and expedite the availability of safe and efficacious treatments for diseases with limited or no treatment options

Many drugs used to treat chronic diseases initially showed potential as COVID-19 treatments, such as lopinavir, ritonavir, nitazoxanide, and hydroxychloroquine. But since then, studies have found that these drugs may not be as effective as once believed. 

In mid-June, the US Defense Advanced Research Projects Agency (DARPA) signed a $16 million agreement with Wyss Institute for Biologically Inspired Engineering at Harvard University to test FDA approved drugs that could be repurposed to treat COVID-19. 

This collaboration will leverage the Institute’s computational drug discovery pipelines and human organ chip technologies, Wyss said. So far, researchers have already found multiple approved compounds that show promise against SARS-CoV-2. 

The team is led by Donald Ingber, MD, PhD, Wyss founding director and professor of vascular biology at Harvard Medical School and Boston Children’s Hospital.

“Our initial successes allowed us to obtain this new support from DARPA, which we hope will greatly accelerate the development of drugs that might be used to prevent the spread of disease in large populations, as this is precisely what is needed before we can all go back to something close to life as usual,” said Ingber, who is also the professor of bioengineering at the Harvard John A Paulson school of engineering and applied sciences (SEAS), and co-founder of Emulate, Inc.

The team also formed relationships with the Beth Israel Deaconess Medical Center (BIDMC) and SUNY Downstate Medical Center.

Currently, the organizations are collecting specimens from COVID-19 patients and carrying out RNA analysis using the sequencing core at the Broad Institute of Harvard and MIT, which will then provide data that they can later leverage in its pipeline, the release concluded.