Altimmune Launches Clinical Trial of T-COVIDTM, an Investigational Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19

• Clearance of IND application received from the U.S. FDA
• Planned Phase 1/2 outpatient clinical trial will focus on patients with early SARS-CoV-2 infection
• Placebo-controlled trial expected to commence in June with data readout expected in Q4 2020
• Therapeutic development program will complement Company’s single-dose intranasal COVID-19 vaccine candidate, AdCOVID
• Company to host conference call on Monday, June 1, 2020 at 8:30 a.m.

GAITHERSBURG, Md., June 01, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the  treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020.

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls. Excessive production of inflammatory cytokines like IL-6 has been associated with the lung pathology and death in COVID-19. The protective effects were independent of any specific immunity or vaccine effects against the challenge virus. These protective effects were only observed with intranasal administration of RD-Ad5, and intramuscular administration provided no survival benefit. 

The Company believes that treatment with T-COVID administered as a single intranasal dose to patients with an early onset of symptoms and recent diagnosis of COVID-19 may prevent the progression to severe lung inflammation and thereby decrease the development of severe COVID-19 and the need for hospitalization. The FDA has agreed that the Company may use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for the planned T-COVID clinical trial allowing the Company to immediately initiate the study.