Factor-H and Skyhawk Therapeutics collaborate to Support Responsible Communication on the Falcon-HD Clinical Trial in Latin America

A central priority for Factor-H is ensuring that information about clinical research is shared in a way that does not create unrealistic expectations or add to the emotional burden faced by individuals and families affected by Huntington’s disease.

While scientific progress is essential and provides reasons for optimism, it is also a long and complex process. Even when studies show promising results, years of additional research or clinical trials, regulatory review, and approval are often required before any therapy may become an established treatment, and access may not be immediate or universal.

The (code named) Falcon-HD study is evaluating the potential therapeutic effects of SKY-0515, an experimental, orally administered small-molecule drug being developed for the treatment of Huntington’s disease by Skyhawk Therapeutics. SKY-0515 is designed to modulate the expression of the HTT gene, whose mutation is the underlying cause of the disease. The compound is currently being evaluated in Phase 1 clinical studies in Australia and New Zealand, with Phase 2/3 trials expected to begin soon and to include clinical centers in Latin America.

Given Factor-H’s longstanding collaboration with Huntington’s disease communities throughout Latin America, Skyhawk Therapeutics requested Factor-H’s support to help ensure that information about the study is communicated in a timely, accurate, and accessible manner.

Factor-H will support educational sessions about clinical trials and will facilitate interactions between the patient associations and the community at large with Skyhawk. As part of this effort, Factor-H will organize a series of virtual informational sessions to support transparent communication.

The objective of this collaboration is to help patients, families, caregivers, and patient associations clearly understand the purpose of the trial, its design, and how to learn more about participation, without promoting the investigational drug or the study itself since Factor-H is a neutral, humanitarian organization. Factor-H does not promote specific drugs or therapeutic approaches and does not conduct, sponsor, or manage scientific or clinical research. Its role in this collaboration is strictly informational and educational. Factor-H would fulfill the same role with any other company that might request help to engage and educate the HD families in Latin America.

The inclusion of Latin American clinical centers in Huntington’s disease clinical trials represents an important milestone for the region. Factor-H remains committed to ethical responsibility, transparent communication, and supporting individuals and families in making informed decisions regarding care and potential participation in clinical research.