Today, Secretome Therapeutics announced that its Phase 2 clinical study, THRIVE-2, has opened for enrollment at participating clinical sites across the United States. The study will evaluate the safety and efficacy of STM-01, an investigational therapy being developed as a potential disease-modifying treatment for people living with Duchenne muscular dystrophy. Secretome Therapeutics expects the first patient to enroll in the study soon. For more information, read Secretome Therapeutics community letter below or view the company’s press release.
Dear Duchenne Community,
Today, we are pleased to share an important milestone for Secretome Therapeutics and our work in Duchenne muscular dystrophy: we have initiated THRIVE-2, a Phase 2 clinical study evaluating our investigational therapy, STM-01, in people living with Duchenne.
THRIVE-2 is a multicenter, multi-dose, open-label study that will evaluate the safety and potential effects of STM-01, including assessments of both skeletal muscle and cardiac function. The study is now open for enrollment, and we expect the first participant to enroll soon.
About STM-01
STM-01 is an investigational cell therapy derived from neonatal cardiac progenitor cells. The cells used to produce STM-01 originate from a small amount of cardiac tissue removed during medically necessary heart surgery in newborns with congenital heart defects that would otherwise have been discarded. With appropriate consent, cells are isolated from the donated tissue and grown to create the cells used to manufacture STM-01.
These neonatal cardiac cells produce a broad range of naturally occurring biological factors that may help regulate inflammation, fibrosis, and tissue repair – processes that are important in the progressive skeletal and cardiac muscle damage that occurs in Duchenne.
Rather than targeting a specific genetic mutation, STM-01 is being studied for its potential to address several biological processes that contribute to muscle damage and loss of function in Duchenne.
THRIVE-2 will help us learn more about the safety of STM-01 and its potential effects in Duchenne. STM-01 is investigational and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority, and its safety and effectiveness have not been established. Participation in a clinical trial is an important personal decision that families should discuss with their healthcare providers and study investigators.
Learning more about THRIVE-2
THRIVE-2 is a small Phase 2 study that will be conducted at multiple clinical trial sites in the United States. As individual sites begin enrolling, information about participating locations, eligibility criteria, and study contacts will be posted on ClinicalTrials.gov. If you would like more information about this study to share with your treating doctor, please reach out to [email protected], or to connect with the patient advocacy team, email us at [email protected].
As we begin THRIVE-2, we want to express our sincere gratitude to the individuals and families living with Duchenne, advocacy organizations, clinicians, researchers, and others who have shared their experiences and perspectives with us. Your input has helped inform our work, and we recognize that clinical research would not be possible without the individuals and families who choose to participate.
We look forward to keeping the Duchenne community informed as THRIVE-2 progresses.
With gratitude,
The Secretome Therapeutics Team