Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced the initiation of THRIVE-2, a Phase 2 clinical study evaluating STM-01 in patients with Duchenne muscular dystrophy (DMD). The study is now open for enrollment, with the first patient expected to enroll imminently.
THRIVE-2 is a multicenter, multi-dose, open-label Phase 2 study designed to evaluate the safety and efficacy of STM-01 in patients with DMD, including assessments of both skeletal muscle and cardiac function.
STM-01 is an investigational biologic therapy derived from neonatal cardiac progenitor cells. Pertinent to DMD, the mechanism of action for STM-01 includes anti-inflammatory and anti-fibrotic properties, with the potential to address key biological processes driving the progressive skeletal and cardiac muscle degeneration in DMD.
“The initiation of THRIVE-2 marks an important milestone for Secretome Therapeutics and brings a novel, investigational cell therapy to the Duchenne community,” said Teji Singh, MD, Chief Medical Officer of Secretome Therapeutics. “Despite meaningful advances in recent years, Duchenne muscular dystrophy remains a devastating disease with substantial unmet medical need. STM-01’s broad and powerful mechanism has the potential to address the multiple biological processes that contribute to disease progression in DMD. We are grateful to the patients, families, investigators, and advocacy organizations whose collaboration has made this study possible, and we look forward to enrolling the first patient shortly.”
“We are pleased to begin recruiting patients in THRIVE-2 imminently, and to evaluate a novel therapeutic approach for individuals living with Duchenne muscular dystrophy,” said Diana Castro, MD, pediatric neuromuscular specialist and clinical investigator for THRIVE-2. “Compared to cell therapies derived from adults, STM-01 is derived from the youngest possible donor, potentially maximizing the regenerative and therapeutic potential efficacy of cell therapy. We look forward to working with patients and families as this study gets underway.”
“Duchenne muscular dystrophy is characterized by ongoing muscle injury, chronic inflammation, and fibrosis, all of which contribute to the progressive loss of skeletal and cardiac muscle function,” said Aravindhan Veerapandiyan, MD, pediatric neuromuscular neurologist at Arkansas Children’s Hospital and associate professor of pediatrics at the University of Arkansas for Medical Sciences. “What is particularly encouraging about STM-01 is its potential to address some of these fundamental mechanisms of tissue injury and remodeling. In head-to-head preclinical studies, STM-01 demonstrated greater improvement in cardiac function and a greater reduction in cardiac fibrosis than several other stem cell approaches. We are excited to participate in THRIVE-2 and to help advance the development of a potential therapy that could ultimately improve outcomes for individuals living with Duchenne.”
“Families living with Duchenne muscular dystrophy urgently need additional therapeutic options, and every thoughtfully designed and studied new therapy brings us closer to that goal,” said Pat Furlong, Founding President and Chief Executive Officer of Parent Project Muscular Dystrophy (PPMD). “We’re encouraged to see continued investment in the development of cell-based therapies that seek to address inflammation and fibrosis—two important contributors to disease progression. We are proud to support Secretome Therapeutics and the clinical investigators advancing THRIVE-2, and extend our gratitude to the families whose participation makes research possible.”
Additional information about THRIVE-2, including participating clinical sites and eligibility criteria, will be available on ClinicalTrials.gov as sites begin enrolling participants.
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About THRIVE-2
THRIVE-2 is a multicenter Phase 2 clinical study evaluating the safety and efficacy of STM-01 in patients with Duchenne muscular dystrophy. The study is currently open for enrollment at participating clinical sites in the United States.
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About STM-01
STM-01 is an investigational biologic therapy derived from neonatal cardiac progenitor cells. The therapy is designed to harness the regenerative activity of the cells’ secretome, which contains naturally occurring bioactive factors with anti-inflammatory and anti-fibrotic properties. By modulating biological pathways involved in chronic inflammation, fibrosis, and tissue repair, STM-01 is being developed as a potential disease-modifying treatment for Duchenne muscular dystrophy.
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About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is a rare, progressive X-linked genetic disorder caused by mutations in the dystrophin gene. The disease leads to ongoing muscle damage, chronic inflammation, fibrosis, progressive loss of skeletal and cardiac muscle function, and premature mortality. Although advances in care have improved outcomes for patients, significant unmet medical need remains for therapies that can slow disease progression and preserve muscle function.
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About Secretome Therapeutics
Secretome Therapeutics is a clinical-stage biotechnology company developing regenerative medicines derived from proprietary neonatal cardiac progenitor cell technology for the treatment of serious diseases with significant unmet medical need. The company’s platform leverages the regenerative potential of the cellular secretome to develop therapies that target inflammation, fibrosis, and tissue repair across multiple disease areas.
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