The NIH has kiboshed Synairgen’s arm of the ACTIV-2 trial testing the company's SNG001 in nonhospitalized patients due to a “significant shift” in the pandemic (read: the omicron variant).
The announcement from Synairgen Tuesday that recruitment was being halted came two weeks after the company first said the NIH had told it to slow its roll while the two tweaked the trial. But evidently, it needed more than just the tightening of a few nuts and bolts, with the company now explaining that it would need a “substantial modification” to proceed. The evolution of the virus plus the changing treatment landscape all factored into the decision, a Synairgen spokesperson explained to Fierce Biotech.
The latest update is a more severe development than what was conveyed on March 3, when Synairgen said the NIH had asked that they pause preparation of “clinical supplies” while the institute retooled the trial in light of the omicron variant. At the time, neither Synairgen nor NIH would provide more details on how the study had to be amended when asked for comment.
The initial delay of Synairgen’s trial came a day after the NIH fully axed SAB Biotherapeutics' treatment arm of the study citing low rates of omicron-related hospitalization and deaths. At the time, NIH said “no other arm of the ACTIV-2 trial has been stopped for that reason.” Evidently, that carefully worded language did not include other ways omicron was impacting trials beyond severe outcomes.
Even though its ACTIV-2 hopes have been dashed, Synairgen is not giving up. It is continuing to work with lead investigators of the trial to try and chart a path forward to continue evaluating its treatment.
“Even with improved standard of care, there remains a critical need to prevent progression to severe disease and death,” said Synairgen CEO Richard Marsden. “As such, we are actively seeking inclusion in platform trials for hospitalized patients and are working closely with the NIH to also find a suitable trial for SNG001 in home-based patients."
Synairgen’s therapy is an inhaled antiviral containing interferon beta, a cytokine which when lacking has been associated with worse COVID-19 outcomes. Even with the pause, the company says it still expects phase 2 data in the first half of this year.
In the wake of the news, the company's shares were down 19% on the London Stock Exchange as of Thursday afternoon, dropping from 26 pence sterling to 21.06.