Secretome Therapeutics Initiated Phase 2 Study of STM-01
The company has begun testing its neonatal cardiac cell-derived biologic in patients with Duchenne muscular dystrophy.
Updated on Sept. 29, 2026 in Biotech
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Secretome Therapeutics has launched the THRIVE-2 Phase 2 clinical trial, an open-label, multicenter study evaluating the safety and efficacy of its investigational biologic therapy, STM-01. The study is currently recruiting patients across the United States to assess the drug's impact on skeletal muscle and cardiac function.
Why it matters
The trial aims to determine if STM-01 can slow or stabilize the progressive muscle degeneration characteristic of Duchenne muscular dystrophy. By targeting chronic inflammation and fibrosis, the therapy seeks to address the biological mechanisms driving decline in skeletal and cardiac tissue.
STM-01 is a biologic derived from neonatal cardiac progenitor cells, or early-stage heart muscle precursor cells. It functions by modulating pathways related to fibrosis—the formation of excess connective tissue—and inflammation, providing a mechanism for potential tissue repair.
The players
Secretome Therapeutics
A Plano, Texas-based biotechnology company focused on developing cell-derived biologic therapies for degenerative muscle conditions.
The details
STM-01 acts by delivering therapeutic factors that counteract the inflammatory and fibrotic processes inherent in Duchenne muscular dystrophy, a genetic disorder causing severe muscle loss. This open-label, multi-dose trial will measure changes in both skeletal and cardiac performance over the course of treatment. The therapy leverages the biological properties of neonatal cardiac progenitor cells to attempt to modify the progression of muscle-related pathology.
Timeline
September 29, 2026: Secretome Therapeutics announced the initiation of the THRIVE-2 Phase 2 study.
The Tech Race
The study sits within the broader competitive field of regenerative medicine targeting Duchenne muscular dystrophy. It advances the race to find effective systemic therapies that can address the specific cardiac complications associated with the disease.
Patients and families currently seeking enrollment options can contact clinical sites now, as the study is open for recruitment. This trial represents a high-stakes effort to develop a novel therapeutic intervention for those suffering from progressive muscle degeneration.
The takeaway
This trial marks a critical transition of STM-01 from preclinical research into human patient evaluation. Observers should track upcoming reports on the first patient enrollment and subsequent safety data to gauge the feasibility of this biologic approach.
What happens next
The first patient enrollment in the THRIVE-2 study is expected to occur imminently.
Further reading
Learn more about the latest research in Biotech to understand how clinical-stage therapies are shifting the landscape of genetic disease treatment.
Source note: This article includes information reported by Firstwordpharma.
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