Positive FDA Pre-IND Meeting for CGN001

Munich, January 8, 2025 - Cardiogen GmbH, a preclinical life-science company focused on cardiovascular regeneration and cellular reprogramming, today announced the successful completion of its Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead program, CGN001, being developed for the treatment of ST-elevation myocardial infarction (STEMI).

During the meeting, the FDA provided positive and constructive feedback on Cardiogen’s proposed non-clinical and clinical development strategy and confirmed that the outlined program could support a future IND application for CGN001 in the proposed indication.

The Pre-IND meeting was convened to obtain regulatory guidance on the remaining preclinical studies, required to enable first-in-human clinical testing of CGN001. The proposed development plan includes the completion of all key pharmacology, toxicology, and CMC activities necessary to support an IND submission and the initiation of a Phase Ib clinical study in patients with anterior STEMI undergoing primary percutaneous coronary intervention (PCI). 

In its written responses, the FDA stated, among other points, that the proposed non-clinical development plan and existing data package are appropriate to support an IND submission for the intended clinical program.

“This positive regulatory feedback represents an important milestone for Cardiogen and significantly de-risks the path toward clinical development of CGN001,” said Dr. Roman Schenk, Chairman of the Board and Co-Founder of Cardiogen GmbH. “We are encouraged by the FDA’s alignment with our development strategy and look forward to advancing CGN001 into the clinic for patients with acute myocardial infarction, where new regenerative approaches are urgently needed.”

About Cardiogen

Cardiogen is developing non-invasive regenerative therapies, aimed at restoring cardiac function, following myocardial injury. The company’s platform in cellular reprogramming and cardiovascular regeneration has the potential to improve survival and long-term quality of life for patients, suffering from heart attack and other major cardiovascular diseases.

For more information, please visit: https://www.cardiogentx.com/ or contact info@cardiogentx.com