Biotechnology company Emergex has completed the Phase 1 naNO-COVID clinical trial in Switzerland that evaluated the safety and reactogenicity of CoronaTcP in healthy volunteers.

CoronaTcP is a multi-target T cell-priming set-point product that targets diseases caused by Betacoronaviruses, including SARS-CoV-1. It is also effective against known and emerging variants of SARS-CoV-2, which can potentially cause a major epidemic or pandemic.

According to the trial’s primary outcome measures, CoronaTcP showed a satisfactory safety profile, with no serious adverse events associated with the treatment.

The majority (88%) of adverse events were minor and the soreness at the injection site was the most frequent.

Regarding general safety or reactogenicity, there was no discernible difference between groups receiving high or low CoronaTcP doses, Emergex said.

In secondary immunogenicity analyses, the evaluation of baseline levels of SARS-CoV-2-specific anti-nucleoprotein antibodies revealed that most individuals had experienced previous SARS-CoV-2 infection.

CoronaTcP does not worsen an acute episode of Covid-19, as evidenced by the fact that some participants seroconverted throughout the trial but only experienced minor symptoms.

Overall, the results of the Phase 1 study support further research into additional T cell-priming immunological set-point candidates from the same platform and support the T cell-based strategy of the biotechnology company for defence against RNA viruses.

In both naNO-DENGUE and naNO-COVID trials, Emergex’s T cell-priming immune set-point candidate showed a favourable safety profile.

Emergex co-founder and CEO Thomas Rademacher said: “The positive data from both clinical trials – naNO-DENGUE and naNO-COVID – represent an important landmark for Emergex.

“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.”

The naNO-COVID trial was a double-blind, randomised, base particle-controlled, single-centre Phase 1 study.

It assessed the safety and reactogenicity of two intradermal injections of CoronaTcP at two different dosages on 26 healthy adult volunteers previously vaccinated against SARS-CoV-2.