Skyhawk Therapeutics Announces First U.S. Patients Dosed in Pivotal FALCON-HD Study Evaluating SKY-0515 in Huntington's Disease
New Huntington’s disease clinical study: FALCON-HD
Skyhawk Therapeutics has announced that the first people in the US have started taking part in a clinical study called FALCON-HD. There are also two study sites in the UK. We wanted to share the news with you.
What is being tested?
The study is testing an experimental medicine called SKY-0515. It’s taken as a tablet once a day. It’s designed to lower two proteins linked to Huntington’s disease: mutant huntingtin and PMS1.
SKY-0515 is still an investigational medicine. Its safety and effectiveness have not yet been established.
About the study
- About 250 people have joined so far, at more than 30 sites in 10 countries.
- People take one of three doses of SKY-0515, or a placebo. A placebo has no active medicine in it.
- The worldwide study plans to enrol 400 people with stage 2 and stage 3 Huntington’s disease, at more than 40 sites. It is still recruiting.
What does this mean?
HDBuzz shares Huntington’s disease research news in plain language. It’s written by scientists, for the global Huntington’s disease community. This is what they said about FALCON-HD:
“The expansion of FALCON-HD into the US is welcome news. It reflects substantial progress in developing SKY-0515 and creates more opportunities for people with HD to contribute to research. But we need to be careful not to confuse trial progress with proof that a medicine works.”
Thinking about taking part?
Joining a study is a personal choice, and it isn’t right for everyone. You can find out who can take part and where at FALCON-HD.com or ClinicalTrials.gov.
Find out where the study is recruiting
We are pleased to share this update as part of an ongoing conversation about the latest drug developments.