Eyegene Inc., which is developing messenger-RNA Covid-19 vaccine, said it would conduct clinical trials in the South African Republic, following Korea and Australia.
In a public notice on Thursday, the company said it had won approval from SAHPRA, the South African Republic's health industry regulator, for phase 1/2a investigational new drug (IND) clinical trial of “EG-COVID” Covid-19 booster shot.
The approval comes on the extension of Eyegene’s plan to expand the number of countries for its phase 1/2a clinical trials of Covid-19 booster shot.
Eyegene said it had completed the phase 1 trial by administering the drug to 20 Australians. It plans to move on to phase 2a trial to search for the efficacy of EG-COVID booster shot on 100 healthy adults in Australia and the South African Republic, including those injected with previously approved vaccines, the company added.
The company said the domestic trials are also proceeding smoothly. It has completed administering the drug in phase 1 trial in Korea (basic vaccination) and Australia (booster shot injection) and is analyzing interim results.
In the domestic phase 1 clinical trial, we have completed the basic vaccination on subjects who had never received a Covid-19 shot, collected data in the first four weeks, and is confirming the safety and partial efficacy,” a company official said.
The official explained that Eyegene conducted a phase 1 trial for booster vaccination in Australia. It also confirms the safety and partial effectiveness after completing booster shot vaccination on subjects receiving Covid-19 shots.
“Among official safety and efficacy results, we will be able to announce the interim analysis result of antibody formation in mid-September after the Chuseok holiday is over,” the official added.
According to Eyegene, EG-COVID, unlike existing Covid-19 vaccines like those of Pfizer and Moderna that use lipid nanoparticles (LNP) as mRNA transmitters, uses cationic liposomes and, therefore, is free from patent infringement issues.
Last month, Moderna filed a suit against Pfizer and BioNTech, saying they infringed on its patent.
Most infectious disease experts warn that it would take a long time to be safe from infection risks long after the Covid-19 pandemic officially ends, the Eyegene official said. According to such predictions, given the characteristics of the Covid-19 virus, its variants will continue to appear and reappear for years. And that shows the need for seasonal Covid-19 once or twice a year like influenza, the official added.
“Eyegene has prepared for such a situation by shifting its development focus to booster shoots,” she said. “After confirming the ongoing clinical trial results, we will reflect them on follow-up clinical designs to shift to the booster shot-oriented clinical trials afterward.”