Positive Outcome of FDA Pre-IND Meeting for KAND567

San Francisco, June 5, 2025 - Recardio Inc., a late stage clinical stage life science company developing therapies for cardiovascular and other diseases, announced that the Pre-IND meeting with the FDA was completed successfully and a positive feedback on the planned clinical development program for KAND567 in ST-elevation myocardial infarction was received. The FDA stated that it agreed the proposed clinical development plan could support a marketing application and be eligible for Fast Track Designation.

Positive Outcome of FDA Pre-IND Meeting for KAND567

The Pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA). The purpose of the conducted Pre-IND meeting was receiving feedback from the FDA on the proposed clinical development plan for KAND567 in ST-elevation myocardial infarction (STEMI).

The proposed clinical development plan included a Phase IIb, randomized, placebo-controlled, double-blind, multi-center study (the FRACTIVE study) to evaluate the cardio protective effects after intravenous and oral administration of KAND567 in patients with anterior STEMI undergoing primary percutaneous coronary intervention and a pivotal Phase III study to further evaluate the safety of KAND567 as well as effect on major cardiovascular outcomes, e.g. mortality and heart failure.

In the written responses, the FDA stated in addition to other details that it agreed that the proposed clinical development plan could support a marketing application for the proposed indication and that it would be reasonable to submit a request for a Fast Track Designation.

In addition it agreed that KAND567’s non-clinical data package and planned activities are sufficient for initiating a Phase III study.

The next planned steps are seeking Scientific Advice from the European Medicines Agency (EMA).

KAND567 is part of the cooperation and planned license agreement between Recardio and the public Swedish biotech company Kancera AB.

About Recardio

Recardio Inc. is a late-stage clinical life science company focusing on therapies for cardiovascular and other diseases.

 The company is located in San Francisco, California, having its operations in USA and Europe.

The company’s lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated pre- and clinically 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.

After receiving FDA and EMA approval, Recardio is currently preparing its global pivotal Phase 3 clinical program in acute myocardial infarction for market authorization in major markets and will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases.

In addition, other development programs are in earlier clinical and preclinical stage.

For more information, visit: http://www.recardio.eu/  or contact pr@recardio.eu