Yesterday we received the following messages from Paul Wang, Vice President, Clinical & Medical Affairs at Seaside Therapeutics, Inc.
Dear all –
I wanted to let you know about a letter that we just posted to the Seaside website.
It is on the main page, under “Families.” Because so many people have expressed interest in providing financial support to Seaside, we realized that we need to provide more informatiom to them.
The new information in the letter is that study 301 (adolescents and adults with FXS, age 12-50 years) was not positive on its primary endpoint. We believe that there are positive hints in the data, but by themselves, they will definitely not be enough to get FDA approval. We are now waiting for the 302 results.
We believe that STX209 is helpful to many people with FXS, based on our data, and the direct feedback we have received from so many families. At the same time, it is very challenging to prove this to FDA’s satisfaction. Commercial investors are primarily motivated by the prospect of FDA approval, and our previous results (study 22001; published last year), got enough money to last until now. The canceled open-label study was initially launched as a 1-year study, and we are very glad we were able to continue well beyond 1 year, in response to the positive feedback we received from so many families and investigators, and we are sorry that we cannot continue it longer. As stated in the website letter Study 302 will continue until it ends, with results expected in late summer. We do not know the results of this study; it is still completely blinded.
We are really touched by the offers to provide financial support to Seaside. Our business people are looking into how we might make this happen, but first we wanted to share the 301 results.
Finally, I want to let you know that we have been overwhelmed by messages (calls and emails) this past week. So far, I think we have returned every call and email, but I’m not sure we can continue to do so. Let me know if any of you would like to talk – I will do my best to carve out some time.