One of the clinical trials finished recently, and we’re now pleased to share the announcement from IntraBio regarding the successful outcome of their pivotal Phase III IB1001-303 trial in AT.
Their trial demonstrated statistically significant and clinically meaningful improved neurological symptoms and everyday function, and was observed to be safe and well-tolerated, with no drug-related serious adverse events.
This is extremely positive news and represents a critical step in the first treatment for AT becoming available.
IntraBio will immediately start the process of seeking approval from the drug regulatory authorities in the US, Europe and other global authorities. We will continue to work closely with them to help ensure a speedy approval by the Medicines and Healthcare products Regulatory Agency in the UK.
On 19th May 2026, the FDA in the US agreed to decide on the regulation of this treatment by September 2026. This is an important and positive step forward and may help to accelerate the process in the UK. Further information can be found here
For more information please visit: Clinical Trials – IntraBio
