Company: 

Recardio Inc

Recardio Inc

Key activities provided by Niche have included over the year of our partnership have included:

  • Editorial and medical writing support – including regulatory documents, scientific manuscripts and conference publications
  • Strategic input on regulatory and medical affairs
  • Compilation and writing of the non-clinical IMPD, Investigator’s Brochure, clinical protocols and study reports
  • Assembling and filing the Clinical Trial Applications and ethics submissions
What our client said

"Based on this personal and team experience, I have always been impressed by the standard of the work delivered by the Niche teams. The native English-speaking writers provided confidence in the written documents they produce and fosters clear communication."

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Roman Schenk, Executive Chairman

Recardio Inc




Project background
RECARDIO (REgenerative CARDIOvascular Therapy) is a late clinical-stage life science company focusing on therapies for cardiovascular and other 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, resulting in healing cardiac tissue after an injury.
Delivery

Niche began discussing Recardio's clinical aspirations and future requirements in 2017 as the company completed recruitment for the Phase 1 study of dutogliptin, which evaluated safety, pharmacokinetics and pharmacodynamics in healthy volunteers after single and repeated parenteral application. The Niche team provided support services for the development of regulatory documents to support the REC-DUT-002 (Phase 2), a global multicentre, double-blind, randomised, placebo-controlled trial that evaluated the safety and initial efficacy of dutogliptin in co-administration with filgrastim as an adjunct treatment for patients in early recovery following an acute myocardial infarction. This was followed by the HEAL-MI study, a global multicentre, randomised, double-blind, placebo-controlled Phase 3 trial that is evaluating safety and efficacy of dutogliptin in co-administration with filgrastim in early recovery post-myocardial infarction.

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