Altimmune Inc. (NASDAQ:ALT) has announced that the FDA has given the company a go-ahead to proceed with its T-COVID clinical trial. T-COVID is Altimmune’s investigational agent for onset COVID-19 treatment.
Altimmune to commence enrolment of Phase 1/2 T-COVID trial
The company expects to begin enrolling patients in the first and second phase trials in June with a readout of data expected in Q4 2020. The investigational agent, T-COVID, is based on the replication-deficient adenovirus five vector technology. RD-Ad5 is the vector tech behind the company’s intranasal vaccines that include Anthrax’s NasoShield, Influenza’s NasoVAX as well as AdCOVID for SARS-COV-2, but its mechanism of action is different.
Recent National Institute of Allergy and Infectious Diseases sponsored preclinical studies to indicate that the intranasal RD-Ad5 vectors administration modulated inherent immune response. There was a significant decline in cellular inflammation due to the immunomodulatory effects and lower IL-6 concentration and inflammatory cytokines in treated animals’ lungs relative to controls.
Usually, excess inflammatory cytokines production, such as IL-6, is linked to lung pathology and mortality on COVID-19 patients. The study showed that protective effects did not depend on a particular vaccine or immunity effects versus the challenge virus. The protective effects were realized in RD-Ad5 intranasal administration with intramuscular administration providing no survival benefit.
FDA approves NasoVAX Influenza vaccine for T-COVID study
Altimmune believes that its T-COVID agent given in single intranasal doses alongside other treatment in COVID-19 patients with onset symptoms or with a recent diagnosis can halt disease progression. This prevents progression to acute lung inflammation and thus decreasing the development of coronavirus and the need for hospitalized patients. The FDA has approved the existing RD-Ad5 lot of NasoVAX influenza inoculation for the anticipated T-COVID clinical study, which allows Altimmune to commence the study.
The anticipated clinical study will evaluate T-COVID’s potential in preventing clinical deterioration in early COVID-19 patients. The company will enroll around 100 patients in the double-blind study who are above 35 years. They will be randomized 1:1 for intranasal T-COVID administration or placebo.