Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) has announced Oravax Medical Inc., its majority-owned subsidiary, has received approval from the South African Health Products Regulatory Authority to start patient recruitment in the first in human, Phase 1 clinical study for the oral COVID-19 vaccines. Preparations to commence the trial are currently underway.
Oravax targets three SARS CoV-2 surface proteins
The virus-like particle (VLP) vaccine tech developed by Oravax targets three SARS CoV-2 virus surface proteins, including those less vulnerable to mutation, potentially making the vaccine more effective against existing and future COVID-19 virus strains. In addition, the VLP vaccine technology developed by Oravax is highly scalable and transportable.
CEO Oramed Nadav Kidron said, “We believe that Oravax’s oral COVID-19 vaccine candidate could offer an exciting potential solution to the COVID pandemic, whether as a booster or for the unvaccinated. An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to administer the vaccine themselves at home. Following this Phase 1 trial, our intention is to move forward with a Phase 2/3 trial for emergency use approval in relevant countries.”
Oramed to evaluated Oravax’s vaccine in 24 volunteers
Oramed will commence clinical trials in 24 unvaccinated volunteers that will be monitored after taking the oral vaccine. The pill demonstrated in animal models that it can produce antibodies. Trials are expected to commence soon and go on for some months.
Kidron explained, “We applied in both Israel and South Africa because when you talk about the COVID-19 vaccine, every hour matters. We know that when you deal with government agencies, time is not always in your control. So we wanted to get it going as soon as possible and that’s why we applied in parallel in both South Africa and Israel. We got IRB (institutional review board) approval in South Africa. We already got that approval to start then in Israel.”
