UK-based biotechnology company Emergex Vaccines has reported ‘promising’ data from the Phase I naNO-COVID trial of CoronaTcP.
The CoronaTcP drug is designed to treat Betacoronaviruses such as SARS-CoV-1 and emerging variants of SARS-CoV-2, the virus that causes Covid-19.
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The randomised, double-blind study was conducted at Centre Hospitalier Universitaire Vaudois, which is part of the University of Lausanne in Switzerland.
It was part of a two-stage clinical trial and was initiated based on safety data from an interim analysis of the first stage, which was named naNO-DENGUE.
The naNO-COVID study assessed the safety and reactogenicity of low-dose 2.5nmol CoronaTcP and high-dose 7.5nmol in healthy adults.
A total of 26 healthy adult volunteers who were previously vaccinated against SARS-CoV-2 were administered intradermally with different dosages using a microneedle device.
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By GlobalDataEach participant received the assigned treatment on days zero and 21. The treatments were then followed up for a further six months.
CoronaTcP demonstrated a favourable safety profile and did not cause any serious adverse events in the trial.
Despite this, mild adverse events were observed in 88% of participants, with injection-site pain being the most common.
In terms of overall safety or reactogenicity, no systematic difference between the two treatment groups was found.
Memory CD8+ T-cells were activated in patients treated with two dosages and at Day 35 post-treatment, an increase in frequencies of CoronaTcP-specific CD8+ CD137+ CD69+ cells was also observed.
Emergex Vaccines co-founder and CEO Thomas Rademacher said: “Demonstrating that our platform has an acceptable safety profile and successfully mobilises specific T-cells that may elicit broad and long-term immune memory, validates our approach.
“By improving T-cell-based immunity, we can enhance any previous immune status.
“We are delighted that this first assessment of a treatment against infectious diseases for clinical use, based solely on a T-cell response, was successful.”
