As Covid research heats up, J&J retires a BARDA-funded flu antiviral they worked on for 7 years
The last eight months have seen a resurgence in antivirals as researchers, scrambling for something that might treat Covid-19, repurposed approved HIV drugs and racked the libraries of small molecules on pharma and biotech’s shelves for any that could inhibit the novel virus. But yesterday, J&J took an antiviral it had been testing for 7 years and formally put it back on the shelf.
J&J announced it was ending development of the experimental influenza drug pimodivir after an interim analysis of a Phase III study showed the drug was “very unlikely” to succeed over standard of care. The company halted both that study, in hospitalized influenza A patients, and another one, in outpatients. The decisions were made in consultation with BARDA, which co-funded the program.
“While our goal was to develop an innovative new treatment option for patients at risk of respiratory infections, unfortunately these data show that pimodivir does not offer a benefit above the existing standard of care,” James Merson, J&J’s infectious disease R&D chief, said in a statement.
As researchers rush to find Covid-19 treatments, the setback is a reminder of the pitfalls of developing antiviral drugs, where progress has been slow outside chronic infections like HIV and Hepatitis C.
As recently as spring of 2017, then-global R&D chief Bill Hait listed pimodivir as one of 14 potential blockbusters for the pharmaceutical giant. But by 2020, it was not exactly J&J’s most-watched asset. They licensed the drug from Vertex for $30 million plus milestones in 2014, back when the Boston biotech was pivoting from a small molecule antiviral engine to a small molecule cystic fibrosis engine. But the company said little about the compound before and after Hait’s announcement. “J&J picked up this one from Vertex in 2014,” we wrote in a 2017 story. “Not much has been heard about it since then.”
That spring, though, the company was about to announce data from a Phase IIa trial testing the drug in patients with influenza. Unlike Tamiflu, Relenza and the majority of approved influenza drugs, pimodivir targeted a part of the RNA polymerase, which the virus uses to replicate, as opposed to neuraminidase, which the virus uses to exit cells. Ideally, it could treat flu viruses that had evolved resistance to other drugs, precipitating BARDA’s interest in the program. And the study showed that across about 270 patients, those who received treatment saw lower viral loads than those on placebo.
J&J subsequently launched two Phase III trials, both of which were terminated this week.
This is J&J’s second recent failure in antiviral research, a field much of the industry had been leaving for years before Covid-19 struck. In 2014, the pharma also spent $1.75 billion to acquire the antiviral company Alios. But in 2018, they suspended development of Alios’s lead RSV drug, taking a $630 million impairment. In 2019, they wrote off another $930 million, essentially declaring the program a bust.
Late last year, the company also received a CRL on their ViiV-partnered long-acting HIV antiviral, a setback in a heated race with Merck.
J&J, of course, is now working with BARDA on a different product: A Covid-19 vaccine. The jury is still out on the candidate but the company has high hopes.