Oramed Pharmaceuticals' Oral COVID-19 Vaccine Candidate Shows Safety, Immunogenicity In Early Study

Oramed Pharmaceuticals Inc's ORMP subsidiary, Oravax Medical Inc, reported preliminary data from its Phase 1 trial of an oral COVID-19 vaccine candidate.
Preliminary Phase 1 trial results from the first cohort include:
- Significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in most patients dosed.
- No safety issues were observed, including mild symptoms.
An open-label, Phase 1 trial will evaluate the safety, tolerability, and immunogenicity of two concentrations of the COVID-19 vaccine administered orally as a two-dose schedule administered 21 days apart.
The first cohort of 12 eligible subjects received one capsule containing the low dose on day one and a second oral dose on day 21. The ongoing trial includes an additional 12 subjects (subjects 13-24) who will receive a high dose on day one and a second dose on day 21.
Subjects will be monitored for safety, tolerability, and antibody titers for 24 weeks after the first dose. An end-of-trial visit will take place 24 weeks after the first dose.
Price Action: ORMP shares are down 6.12% at $6.14 on the last check Friday.