Oragenics Says All Three Australian Concussion Trial Sites Enrolling Patients
Oragenics (OGEN) said Tuesday that the three sites in its Australian phase 2a clinical trial of ONP-002 to treat mild traumatic brain injury, or concussion, are now active and enrolling patients. The biotech firm said that there have been no serious adverse events reported among all patients dosed to date, and that it continues to expect to present phase 2a data in Q4. Oragenics also said it has submitted a Type B meeting request to the US Food and Drug Administration for guidance on its planned US clinical development program for ONP-002 that is intended to support an Investigational New Drug application. The company said it is aiming to submit its application in Q4. Shares of Oragenics were up 6.3% pre-bell.
Oragenics (OGEN) said Tuesday that the three sites in its Australian phase 2a clinical trial of ONP-002 to treat mild traumatic brain injury, or concussion, are now active and enrolling patients.
The biotech firm said that there have been no serious adverse events reported among all patients dosed to date, and that it continues to expect to present phase 2a data in Q4.
Oragenics also said it has submitted a Type B meeting request to the US Food and Drug Administration for guidance on its planned US clinical development program for ONP-002 that is intended to support an Investigational New Drug application.
The company said it is aiming to submit its application in Q4.
Shares of Oragenics were up 6.3% pre-bell.