080210xf's Blog

L'X fragile sera vaincu | Fragile X will be conquered

Seaside advances autism drug

Boston Business Journal – by Julie M. Donnelly|

Seaside Therapeutics has issued positive results for a second phase 2 clinical trial on its drug candidate to treat autism.

While the first study focused on fragile X syndrome, the most common cause of autism, the second study expanded the indication to a variety of autism spectrum disorders. The company has decided to move forward with phase 3 trials for the potential therapy, called STX209, in both indications. The Cambridge-based biotechnology company said that the study showed a marked improvement in patients’ symptoms, including irritability and social withdrawal.

“These study results add to a growing body of evidence supporting the potential of STX209 to play an important role in treating neurodevelopment disorders such as fragile X syndrome and autism spectrum disorders,” Dr. Randall L. Carpenter, Chief Executive Officer of Seaside Therapeutics, said in a statement. “In addition, we have now observed significant improvement in social interaction across two studies. We believe the reduction in social withdrawal is important as it suggests that STX209 is demonstrating efficacy for a core symptom of both fragile X syndrome and autism.”

The second trial for the broader therapeutic indication was conducted as a so-called open label study, which means there was no control group taking a placebo. This type of study is considered to be less scientifically rigorous. The first study, focusing on fragile X, was a placebo-controlled study.

Thirty-two patients with autism spectrum disorders between the ages of 6 and 17 were enrolled in the study. Two patients withdrew from the study due to a worsening of their symptoms. Another patient reported a serious adverse event, a worsening of aggression, as the patient transitioned off the drug.

Read more: Seaside advances autism drug – Boston Business Journal

No comments yet»

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: