SOUTH AFRICA – Oramed Pharmaceuticals has received clearance from the South African Health Products Regulatory Authority to start patient enrollment in a Phase 1 clinical trial for its Oravax pill.
The Israeli inventors of the oral coronavirus vaccine have received the green light to start clinical trials in South Africa, and expect to be up and running next month.
“We’re excited to be moving ahead with clinical trials of our oral COVID-19 vaccine in South Africa,” Nadav Kidron, CEO of Oramed, the company behind the pill, said, adding that as boosters are increasingly recommended, his pill could provide an effective way of keeping vaccinations up to date.
The South Africa trial is expected to run concurrently with a Tel Aviv trial that will start soon when approvals by Israel’s Health Ministry are finalized.
The vaccine will be suitable for use as an initial inoculation or a booster, Kidron added, noting that for either use it has “many benefits.”
He said, “These include ease of distribution and the fact that most people prefer to take a pill rather than a shot, especially in Africa. Especially in countries with low vaccination rates, a safe, effective and easy to swallow vaccine could be a game-changer in combatting the virus and getting life back to normal.”
Oravax is a single-dose oral version of a prospective vaccine being developed in partnership with India-based Premas Biotech, and in March announced that it had successfully generated antibodies in pigs.
It hopes that the pill will be suitable as a simple initial vaccination, as it won’t need to be stored at low temperatures and eliminates the need to have professionals administering injections.
“We believe that Oravax’s oral COVID-19 vaccine candidate could offer an exciting potential solution to the pandemic, whether as a booster or for the unvaccinated,” said Kidron.
He also added that, “An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale 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 and 3 trial for emergency use approval in relevant countries.”
Pill based options forCovid-19 are on the rise. Early last month, an experimental antiviral pill developed by Merck & Co proved to halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.
If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Current treatment options include Gilead Sciences Inc’s (GILD.O) infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.
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