A day after axing a study of SAB Biotherapeutics' COVID-19 antibody, the National Institutes of Health (NIH) has placed another arm of the trial on hold, this time for Synairgen’s inhaled medicine.
Synairgen said Thursday that the study is temporarily paused "in light of the emergence of the Omicron variant." The company did not disclose how the study will be changed to address the variant, but it's on hold until “the timeline for the activation of this agent in the trial is clarified.”
The pause comes a day after the NIH ditched SAB Biotherapeutics’ polyclonal antibody treatment from the trial as a result of declining COVID hospitalization and death rates. At the time, the National Institute for Allergy and Infectious Diseases said the ACTIV-2 trial was ongoing and SAB was the only treatment arm to be stopped due to low omicron-related hospitalizations and deaths.
ACTIV-2 was launched in August 2020 to test novel COVID therapies and has included both Big Pharmas and smaller biotechs alike. AstraZeneca’s antibody combination Evusheld was the latest authorization to come from the trial.
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Synairgen’s treatment is an inhaled antiviral containing interferon beta, a cytokine produced in the lungs during viral lung infections to help the immune system. Prior research has indicated that a lack of interferon beta has been associated with cases of critical or severe COVID-19.
The ACTIV-2 development came as the U.K.-based company announced the treatment had “potent antiviral activity” against both the delta and omicron variants.
Synairgen will now have to wait for the phase 3 ACTIV-2 trial to get underway, but, in the meantime, a readout of phase 2 data for the therapy is expected by the middle of the year.