Secretome Therapeutics Granted FDA Fast Track Designation for STM-01, a Neonatal Cardiac Progenitor Cell Therapy for HFpEF

DALLAS--(BUSINESS WIRE)--Secretome Therapeutics, a pioneering company in the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, the company’s neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF).

HFpEF is a debilitating condition affecting millions of patients worldwide, characterized by impaired heart relaxation and elevated left ventricular (LV) filling pressure despite a normal or near-normal ejection fraction. With limited disease-modifying treatments available, HFpEF remains a significant unmet medical need in cardiovascular medicine.

"The FDA’s decision to grant Fast Track designation to STM-01 highlights the critical need for innovative therapies to address HFpEF, a condition with limited treatment options," said Vinny Jindal, President and CEO of Secretome Therapeutics. "This designation marks a pivotal regulatory milestone as we prepare to initiate our Phase 1 clinical trial. It provides us with an opportunity to expedite the development of STM-01 and advance our mission of delivering a first-in-class regenerative therapy for patients in need."

The FDA’s Fast Track program is designed to facilitate the development and expedite the regulatory review of therapies that address serious conditions with unmet medical needs. With this designation, Secretome Therapeutics will benefit from increased interactions with the FDA, including the potential for priority review and a rolling submission of its Biologics License Application (BLA) for STM-01.

About Secretome Therapeutics

Secretome Therapeutics is developing therapies derived from neonatal cardiac progenitor cells (nCPCs) to address life-threatening cardiovascular diseases and conditions driven by inflammation. Our lead drug is STM-01, a first-in-class cellular therapy designed to reduce inflammation, inhibit fibrosis, and support tissue repair in DCM and HFpEF. We are also developing STM-21, a secretome-based therapeutic in preclinical development for inflammatory conditions, including skin wounds and co-morbidities of diabetes.

About STM-01

STM-01 is an investigational, allogeneic neonatal cardiac progenitor cell (nCPC) therapy to improve cardiac function in patients with HFpEF and other inflammatory-driven cardiovascular diseases. Preclinical studies have demonstrated that STM-01 has the potential to reduce inflammation, inhibit fibrosis, and support cardiac tissue repair. A Phase 1 clinical trial is preparing to be launched evaluating safety and preliminary efficacy of STM-01 in HFpEF.