- Oramed Pharmaceuticals Inc ORMP Subsidiary, Oravax Medical Inc, reported preliminary data from its Phase 1 trial of an oral COVID-19 vaccine candidate.
- Preliminary results from the Phase 1 study from the first cohort include:
- Significant antibody response (2- to 6-fold above baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in most treated patients.
- No safety issues were observed, including mild symptoms.
- A Phase 1 open-label study will evaluate the safety, tolerability and immunogenicity of two concentrations of the COVID-19 vaccine administered orally as a two-dose schedule 21 days apart.
- The first cohort of 12 eligible subjects received a low dose capsule on day one and a second oral dose on day 21. The ongoing study 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. At the end of the study, there will be a visit 24 weeks after the first dose.
- Price promotion: ORMP shares are down 6.12% to $6.14 on the last check Friday.
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