Oragenics Receives Approval for Phase 2 Study (Pharmacy Choice)

UF Innovate | Sid Martin Biotech alumni startup Oragenics announced that it has been approved in Belgium to enroll patients in its Phase 2 trial for its drug AG013 for a mouth disorder, Oral Mucositis (OM).

Receiving this clearance and allowing the company to expand its trial globally gives it an advantage to finish the trial in 2019 along with financing from recent warrant exercises, generating proceeds of approximately US$9.5 million.

Following regulatory milestones such as enrollment targets, Oragenics expects to finish enrollment mid-2019 and release topline data from the trial between the middle and second half of the same year. Around 30 patients are currently enrolled in the ongoing trial in the US with the company planning to enroll close to 200.

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