(03) 9818 6333 / 1800 063 501 (Toll Free)
IMPORTANT CLINICAL TRIAL UPDATE
Sky-0515 9-month data release
Early Biological Findings Show Target Engagement
In a nine-month interim analysis from a Phase 1 study in early-stage Huntington’s disease, SKY-0515 showed dose-dependent reductions in mutant huntingtin (mHTT) in blood, with average reductions of approximately 62% at the higher dose. Reductions of about 26% in PMS1 mRNA were also observed. Importantly, SKY-0515 was shown to reach the brain, indicating engagement with its intended biological targets. The clinical significance of these findings is not yet known.
Safety Observations to Date
SKY-0515 has been generally well tolerated in the Phase 1 study so far. No significant safety concerns were identified in the reported data. Safety monitoring is ongoing as clinical studies continue.
Clinical Measures Are Exploratory and Ongoing
Exploratory clinical assessments, including the Composite Unified Huntington’s Disease Rating Scale (cUHDRS), showed generally stable average scores over time, with small average improvements observed after nine months of treatment. Because this is an early-phase study with a limited number of participants, these results should be interpreted with caution. Larger and longer studies are needed to better understand potential effects on symptoms or disease progression.
What’s Next & How the Community Can Stay Engaged
Participants in the Phase 1 study continue in a blinded extension, with additional data expected in mid-2026. The Phase 2/3 FALCON-HD study is currently enrolling in select countries, with additional locations planned. Skyhawk remains committed to transparent communication and ongoing engagement with the Huntington’s disease community through patient advocacy organizations, events, and educational forums.
Want to know more? Click on the button below read the official community letter from the Skyhawk team!
Read the below update to know more about the SKY 0515 therapeutical molecule and its proposed effect on reducing the mutant HTT protein
