San Francisco, September 14, 2020 – Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced publication of the study protocol for its Clinical Phase 2 Study. Entitled “Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction”, the article can be accessed here: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04652-0
The article provides a comprehensive description of Recardio’s phase 2 study protocol to evaluate a novel combined pharmacologic therapy in patients who experienced a severe type of heart attack called STEMI. The therapy consists of a two week treatment that starts within 36 hours after the STEMI and includes filgrastim, a growth factor to boost stem cells in circulating blood, and Recardio’s dutogliptin, a small molecule that enables sustained recruitment and targeting of those stem cells to the site of cardiac injury. The article reviews the study protocol’s background, objectives, trial design, and methods including interventions, data management, statistical analysis, coordination, data monitoring, reporting, and others. Based on the protocol, besides examining safety and tolerability of the combined treatment with dutogliptin and figrastim, results of the study will lay the foundation for an appropriately powered pivotal trial to confirm the efficacy of this therapeutic approach in patients with STEMI.
The Phase 2 study is currently ongoing in multiple centers. The presentation of final outcomes is expected in 2021. Details of the ongoing Phase 2 study can be found at: https://clinicaltrials.gov/ct2/show/NCT03486080
Dr. Roman Schenk, Executive Chairman of Recardio, expressed his gratitude to the multinational group of clinical and scientific advisors who designed the protocol. “The protocol as described in this publication is solid and has been implemented successfully; we look forward to the conclusion of the study despite the recent obstacles placed by the pandemic.”
Recardio Inc. is a clinical-stage life science company focusing on therapies for cardiovascular and other diseases, oncology and infectious diseases. The company is located in San Francisco, California, and is having its operations in USA and Europe. The company’s lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration. In addition to its current Phase 2 cardiovascular clinical program, Recardio will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival.