Altimmune announced that the FDA has approved the company’s IND for a Phase 1/2 clinical trial of its T-COVID intranasal therapy for the treatment of COVID-19, with data expected to be available in the fourth quarter of 2020. Earlier this year, Altimmune announced a partnership with the University of Alabama Birmingham for development of an intranasal vaccine for COVID-19 called AdCOVID.
According to Altimmune, pre-clinical studies of T-COVID have demonstrated that the intranasal formulation reduces inflammation and cytokine concentrations in the the lungs of treated animals, with those effects separate from immune effects.
T-COVID is based on the same adenovirus 5 vector technology as Altimmune’s intranasal vaccine candidates AdCOVID, NasoVax, and NasoShield, and the FDA has okayed the use of an existing lot of NasoVax influenza vaccine for the study, the company said. In March 2019, the company said that a Phase 2 study had demonstrated that NasoVAX provided protection against the flu for more a year following vaccination.
The T-COVID clinical trial is expected to enroll 100 COVID-19 patients aged 35 years and older who have had symptoms for 48 hours or less and have been diagnosed within 24 hours. Those patients will receive either intranasal T-COVID or placebo in an outpatient setting.
Altimmune President and CEO Vipin K. Garg commented, “The preclinical data on RD-AD5 and the potential applicability of our vector technology as a therapeutic approach to COVID-19 suggests that we may be able to protect patients with COVID-19 from the need for hospitalization. With the addition of T-COVID, we now have both a vaccine candidate and a therapeutic candidate in development as our team is working rapidly and diligently to fight this pandemic.”
Read the Altimmune press release.
