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Oramed Pharmaceuticals (NASDAQ:ORMP) said oral COVID-19 vaccine candidate met the main and secondary goals of safety and immunogenicity as per preliminary data from a phase 1 trial.
Oramed's unit Oravax Medical's oral vaccine candidate combines Oramed POD technology with Premas Biotech's D-Crypt Platform as a triple antigen VLP vaccine that targets three major surface proteins of the SARS-CoV-2 virus - Spike, Membrane and Envelope, the company said in an Oct. 7 press release.
The phase 1 study is a dose-finding trial in up to 24 healthy volunteers. The first group of 12 eligible people received one capsule containing the low dose on day 1 and a second oral dose on day 21. The ongoing trial will include an additional 12 people who will get a high dose on day 1 and a second dose on day 21.
Preliminary phase 1 trial results from the first group, showed significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens seen in majority of the patients dosed, the company noted.
"We're very encouraged by this initial data, which indicates that our platform can be safely and successfully used to orally deliver protein-based vaccines," said Nadav Kidron, Oravax chairman and CEO of Oramed.
Oramed added that no safety issues were seen, including mild symptoms.
ORMP -1.07% to $6.47 premarket