Taysha Advances REVEAL Pivotal Trial for Rett Syndrome

Taysha announced today that their REVEAL pivotal trial is expected to begin enrollment in the last quarter of this year.  A pivotal clinical trial gathers a comprehensive set of data for review by regulatory agencies like the FDA or EMA with the goal of obtaining regulatory approval to market the therapeutic.

The study, which is open label, will enroll 15 girls and young women between the ages of 6 and under 22 years old. The primary endpoint in the study will measure the percentage of participants who gain or regain a least one milestone.

A separate safety study in girls between the ages of 2 and under 6 years is being planned.

Questions can be directed to patientaffairs@tayshagtx.com

More information is available by reading Taysha’s community letter and press release below.