Altimmune has discontinued development of its AdCOVID intranasal vaccine for the prevention of COVID-19 after the failure of a Phase 1 trial and has stopped enrollment in a Phase 1/2 trial of its T-COVID intranasal therapy for COVID-19 the company said. The FDA had cleared the IND for the Phase 1 trial of AdCOVID in February 2021; the Phase 1/2 trial of T-COVID was initiated in June 2020.
Earlier this year, Altimmune announced agreements with Summit Biosciences and Lonza for manufacturing of AdCOVID, with Summit set to manufacture a multi-dose version of AdCOVID and Lonza agreeing to dedicate a manufacturing suite to production of the single dose nasal vaccine.
According to Altimmune, the Phase 1 trial of AdCOVID in 80 healthy adults demonstrated an immune response that was “substantially lower than what had been demonstrated for other vaccines already authorized for emergency use” for any dose level of AdCOVID. The immune response was also significantly lower than for the company’s NasoVax flu vaccine. A Phase 2 study of NasoVAX had demonstrated that it protected against the flu for more a year following vaccination.
The T-COVID trial, which had been expected to enroll 100 COVID patients, was terminated because significant levels of vaccination and reduced incidence of COVID-19 infection in the US made it impossible to enroll a a sufficient number of subjects in the third cohort of the study, the company said. Altimmune said that it will discuss the possibilities for further development of T-COVID with its partners before deciding whether or not to proceed.
Altimmune Chief Scientific Officer Scot Roberts commented, “The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial. Unlike the NasoVAX study, the AdCOVID study population lacked immunity from prior infection or vaccination. We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID.”
Read the Altimmune press release.
