A new nonprofit wants to design cheap drug trials, aiming to build on massively successful Covid-19 study
The UK’s RECOVERY trial, a platform study evaluating several potential treatments for Covid-19 using the NHS’ network of hospitals, has proven one of the most successful pandemic endeavors, likely saving hundreds of thousands of lives. Its creators want to tackle other diseases in a similar manner, and they’ve secured some Big Pharma cash to get started.
Led by RECOVERY mastermind Martin Landray, the nonprofit Protas launched Monday with $6.8 million from Sanofi. The goal is to design and develop cost-effective large scale clinical trials across a wide range of diseases, partnering with pharma companies, clinical sites, academic institutions and patient groups along the way.
“As we have seen during the recent pandemic, large randomized clinical trials are critical for the proper assessment of possible treatments,” Landray said in a statement. “The situation is not [unique] to the pandemic; there are many other common and other life-threatening diseases… where better treatments are needed to reduce the huge burden on patients and the NHS.”
In addition to the Sanofi partnership, Protas has also won an NHS grant for an undisclosed sum. The nonprofit expects to begin designing its first trials in 2023.
RECOVERY is largely credited with discovering how dexamethasone, a cheap corticosteroid, can lessen the risk of death in hospitalized Covid-19 patients. Landray and his team delivered the result early on in the pandemic, launching the study back in March 2020, giving hospitals a tool to fight the most severe Covid-19 cases.
The trial also showed the Regeneron/Sanofi monoclonal antibody and the rheumatoid arthritis drug Actemra worked in the same patients, while finding other treatments like hydroxychloroquine and convalescent plasma were not effective.
Given the ballooning costs of conducting clinical studies, Protas now wants to expand the methodology to other common disease areas — its launch statement lists heart, lung and respiratory disease, arthritis, cancer, depression and dementia as areas of interest. Landray and his team plan to design their own studies from scratch, focusing on clinical trials’ most essential aspects.
Some pharma companies can even spend hundreds of millions of dollars on a single drug candidate, but Protas hopes its efforts to streamline R&D will lead to more drugs being developed at a fraction of their current costs. And working as a nonprofit will make the studies both more affordable and improve their quality, Protas says.
Making platform studies the norm is an idea that has been floated before, particularly by Landray himself. In a February 2020 article in NEJM, Landray wrote how pharma companies were increasingly turning to real-world evidence to cut costs, relying on that “myth” instead of randomized studies.
But by focusing only on the essentials, Protas is hoping to reverse the trend and remind the industry of the “magic” behind randomization.