Transcript
Note: This was generated via Vimeo and may not be exactly as spoken.
Hello, my name is Juan-Carlos Gomez. I’m the Chief Medical Officer at Shionogi. I am here to update the Fragile X syndrome community in the U.S. on the progress of Shionogi EXPERIENCE clinical trials. These are the trials previously conducted by Tetra, which is now, as some of you may know, a subsidiary of Shionogi, and I want to share where we are in the overall development of this program.
I would like to start by expressing our sincere gratitude for the support from this incredible community, both clinical investigators, study staff, study participants, and their families. Your role is crucial to advancing the hope for new therapies. I also want to reassure the community of Shionogi’s commitment to this project as we are now close to reaching a very important milestone in the program, which is the full recruitment of the phase three trials.
Let me start with our study in adults. A recent search in participation has enabled the adult study experience […] to complete recruitment, and this has been earlier than we anticipated.
Patient screening has closed, and no new appointments can be scheduled for this trial. At this time, I would like to acknowledge that there are families who may have been waiting for an appointment or were waiting for an appointment in the next few months. Now, obtaining that appointment is no longer an option. The decision to close enrollment in the study has been made as we reached the maximum number of participants that we could include in the study.
The study is being conducted under a protocol approved by FDA, which has a specific number of participants, and that number cannot be exceeded or only by a small percentage. In addition, enrolling more than the planned number may exceed the available supply of a study medication.
We know the announcement to close new participant enrollment came very suddenly. We have tried to accommodate families who had appointments for screening visits in this latter part of March, but that may not have been possible in all cases.
I would really like to offer my sincere apologies to the families who have their plans and their expectations disrupted due to this shift in timelines. In relation to study 204, our adolescent study enrollment is also nearing the end.
For this adolescent study experience 204. All scheduled participants are proceeding as planned with visits, screening visits scheduled in March and April, but no new appointments are available. Then in relation to study 302, the open-label extension study continues without changes, so participants completing the double-blind placebo controlled studies remain eligible to continue in the extension study. Completing the study enrollment in studies 301 and 204 is of course a critical step towards completing the studies themselves. Once the treatment phase of the studies are completed,we will then proceed to look at the database, the statistical analysis, and the data interpretation in the latter part of this year.
Once the study results are available and fully interpreted, we will come back with news to share with the study participants and families, with the study investigators, and with the Fragile X community at large to finalize.
I’d like to emphasize again, our commitment to and our appreciation for this incredible Fragile X community in the U.S. We are working hard to complete these clinical trials and are hopeful that we might bring a new treatment to you.
Thank you.
