Biopharmaceutical company Altimmune (Nasdaq: ALT) has announced a phase 1/2 clinical trial evaluating the utility of their replication-deficient adenovirus 5 (RD-Ad5) vector therapy T-COVID for the prevention of clinical deterioration in non-hospitalized patients with diagnosed COVID-19.
The double-blind placebo-controlled trial has been authorized by the United States Food and Drug Administration (FDA) and is expected to start in June with data available in the fourth quarter of 2020.
T-COVID, which would be administered intranasally via a single dose, consists of the same RD-Ad5 vector technology as Altimmune’s other vaccine candidates and is intended to prevent the damaging lung immunopathology characteristic of severe cases of COVID-19.
According to Altimmune, National Institute of Allergy and Infectious Diseases (NIAID)-sponsored preclinical studies of intranasally-administered RD-Ad5 vectors demonstrated modulation of “the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death.”
As compared to control animals, the mice treated with the vectors were observed to have “significantly decreased cellular inflammation” and reduced levels of inflammatory cytokines including interleukin 6 (IL-6), whose over-expression has been associated with the lung inflammation and mortality of COVID-19.
The survival benefit associated with the vector was not thought to be related to an immune response against the virus and was observed only after administration through the nasal route, as intramuscular administration was not found to improve the survival of the mice.
According to Altimmune’s press release, their team “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.”
President and CEO of Altimmune Vipin K Garg, PhD, stated, “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.”
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“I am encouraged by the potential use of T-COVID in the treatment of respiratory viral illnesses like COVID-19. There is a serious unmet need for therapeutics for this condition, and while multiple investigative efforts are underway, they are mainly focused on the hospitalized patients with established pulmonary deterioration,” stated Michael Yin, MD, Associate Professor of Infectious Diseases at Columbia Presbyterian Hospital and Lead Investigator of the clinical trial.
“T-COVID focuses on the prevention of worsening in patients not yet hospitalized and has the potential of being broadly applied to other respiratory illnesses and future pandemics,” Dr. Yin continued.
100 patients at least 35 years of age are expected to be enrolled in the clinical trial and randomly assigned at a 1:1 ratio to receive either T-COVID or a placebo “within 48 hours of onset of symptoms and 24 hours of diagnosis.”
The study’s primary efficacy endpoint will be “the proportion of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation (SpO2), or need for hospitalization.”
Other non-vaccine-based approaches to preventing COVID-19 are also under development, including neutralizing antibodies developed by Vir Biotechnology.