Candidate: T-COVID
Type: Intranasal immune modulator for COVID-19, based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, including the company’s other COVID-19 candidate AdCOVID.
Status: Altimmune said June 29 it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund the entire cost of its Phase I/II clinical trial of T-COVID in outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the U.S. Department of Defense (DoD).
The Phase I/II trial is set to start “in the coming weeks,” Altimmune said, with data readout expected in the fourth quarter. If the Phase trial is successful, the company plans to launch a Phase II/III trial of T-COVID early next year, and begin talks with the FDA about a potential Emergency Use Authorization.
Earlier in June, Altimmune said it expected to commence the Phase I/II outpatient trial following FDA clearance of its IND. The planned double-blind clinical trial is expected to enroll approximately 100 patients who are 35 years and older randomized 1:1 to receive either intranasal T-COVID or placebo administered in an outpatient (non-hospitalized) setting within 48 hours of onset of symptoms and 24 hours of diagnosis.
The study will be enrolled in three cohorts of increasing risk factors for severe COVID-19, with the final cohort enrolling patients of all ages and risk factors. The trial’s primary efficacy endpoint is the proportion of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation (SpO2), or need for hospitalization.
The lead investigator of the trial is Michael Yin, MD, associate professor of Infectious Diseases at Columbia Presbyterian Hospital.
T-COVID is designed to complement Altimmune’s single-dose intranasal COVID-19 vaccine candidate, AdCOVID. T-COVID is intended for non-hospitalized patients prior to the development of pulmonary dysfunction, and is being developed to prevent the progression to severe lung inflammation and thereby decrease the development of severe COVID-19 and the need for hospitalization.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
