TrialSignal
Clinical trial intelligence report
A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 24, 2026
Report code
NCT07378644-Jun 24, 2026
NCT ID
NCT07378644
Status
RECRUITING
Phase
Phase 2/3
Sponsor
Skyhawk Therapeutics, Inc.
Executive brief
Investment-Ready Snapshot
Skyhawk Therapeutics, Inc. is advancing SKY-0515 through a pivotal Phase 2/3 clinical trial aimed at addressing the unmet medical need in Huntington's Disease, a rare neurodegenerative disorder. The trial's design, which includes a randomized, double-blind, placebo-controlled approach, positions SKY-0515 as a potentially significant therapeutic option in a market with limited effective treatments. The estimated enrollment of 400 participants across multiple international sites indicates a robust commitment to data generation. Given the increasing prevalence of HD and the growing focus on neurodegenerative diseases, successful outcomes could lead to a strong market entry and competitive advantage, particularly if SKY-0515 demonstrates superior efficacy and safety profiles compared to existing therapies. Additionally, the trial's focus on pharmacodynamics and comprehensive efficacy measures enhances its potential attractiveness to investors and partners.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT07378644
Indication
Huntington Disease
Modality
small molecule
Target
SKY-0515 targets the mutant huntingtin (mHTT) protein associated with Huntington's Disease (HD) by reducing its levels, as well as lowering postmeiotic segregation 1 (PMS1) protein, which is implicated in somatic CAG repeat expansion, a key driver of HD progression.
Intervention
SKY-0515, SKY-0515 Placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.