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BayPAT’s Licensee Recardio and FDA reach agreement on Pivotal Phase 3 Regenerative Post-Myocardial Infarction Trial Design for Dutogliptin

Jun 20, 2022

BayPAT, a service provider offering services in the area of technology transfer, IP management and IP commercialisation, today announced that its licensee Recardio reached agreement with the U.S. Food and Drug Administration (FDA) for Recardio’s planned pivotal Phase 3 trial for regenerative therapy in early recovery post-myocardial infarction.

The regenerative therapy concept of Recardio with its DPP-IV inhibitor dutogliptin is subject to a licence agreement concluded in 2012 between BayPAT and Recardio and is based on an invention originating from Ludwig-Maximilians-University of Munich, Germany.

Recardio’s Phase 2 trial results demonstrated the excellent safety profile of its lead drug dutogliptin along with data suggesting potential positive effects on cardiac function and were presented in May at the World Congress on Acute Heart Failure 2022 in Madrid. Along with data suggesting potential positive effects on cardiac function, it was concluded that a pivotal study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted.

After reviewing the phase 2 trial results, FDA agreed with the proposed study design and sample size for the pivotal Phase 3 study of dutogliptin in co-administration with filgrastim in early recovery post-myocardial infarction. A comparable agreement was also reached with the European Medicines Agency (EMA).

The global pivotal study, named HEAL-MI, will enroll 4.000 acute myocardial infarction patients with ST-elevation myocardial infarction (STEMI) but not specified left ventricular ejection fraction (LVEF) and with facilitated screening procedures, which will accelerate the total enrollment. The primary endpoint is a combined clinical endpoint with a Quality-of-Life evaluation as secondary endpoint.

Based on this advice, preparations are already under way for the study that is intended to start in the course of 2022 and will enroll patients in the key global regions - US, Europe and China.

The regenerative therapeutic approach of Recardio to minimize and repair the heart muscle injury that follows an infarction consists of mobilizing, recruiting, and homing stem cells in vivo by using cytokines and inhibitors. Specifically, the growth of stem cells and improvement of cardiac function is achieved by the mobilization of stem cells from the bone marrow using G-CSF. The mobilized stem cells enter the bloodstream and are directed to the site of myocardial injury by dutogliptin. Dutogliptin is a small molecule inhibitor of dipeptidyl peptidase-IV (DPP4). It is responsible for the activation of stromal derived factor-1α (SDF-1α), a cytokine responsible for the binding of circulating stem cells in the area of ischemic injury.

“This is great news for the management of cardiac infarction and demonstrates the regenerative therapy concept of and the competence of the Recardio team.” said Dr. Robert Phelps, BayPAT’s Managing Director.

“We appreciate the positive feedback the FDA and are looking forward to contributing with this HEAL-MI pivotal trial to further therapeutic options for the respective patients with myocardial infarction – initiated by a successful cooperation between academia in Bavaria, BayPAT and Recardio.” commented Dr. Roman Schenk, Recardio President.

More information about the clinical program is available under

About BayPAT

Bayerische Patentallianz GmbH (BayPAT) was founded in 2007 by the Universität Bayern e.V. and the Hochschule Bayern - the Bavarian Universities of Applied Sciences - e.V. as the central patent and marketing agency to foster technology transfer of Bavarian Universities, University Hospitals and Universities of Applied Sciences and is responsible for 28 research institutes. Under the umbrella of the Bavarian Research and Innovation Agency (BayFIA), BayPAT ( is a full-service technology management provider offering services in the areas of technology transfer, IP management and IP commercialisation. Key clients are the Bavarian Universities, University Hospitals and Universities of Applied Sciences and its over 25,000 associated scientists, as well as non-university research institutes, industry and independent inventors worldwide. BayPAT’s main focus in assessing and exploiting IP are the areas of therapeutics, diagnostics, biotechnology, chemistry, medical technology, physics, automotive industry, energy and environment engineering, information and communication technology as well as mechanical engineering.


Dr. Robert Phelps, Managing Director
Bayerische Patentallianz GmbH
Prinzregentenstr. 52
80538 München
Tel. +49 (0)89 54801770

About Recardio

Recardio Inc. 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 having demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration resulting in healing cardia tissue after an injury.

Recardio is currently initiating 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 preclinical stage.

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