DGAP-News

Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP Manufacturing Capacities

DGAP-News: Formycon AG / Key word(s): Miscellaneous Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP Manufacturing Capacities 24.02.2021 / 07:00 The issuer is solely responsible for the content of this announcement.

Press Release // February 24, 2021

Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP Manufacturing Capacities

- Process development, preclinical as well as concepts for clinical phase I and phase II aligned

- Accelerated review of applications for clinical trials

- Manufacturing capacities for FYB207 assured at experienced German GMP manufacturer

- Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) in preparation

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific Advice, the Federal Institute for Vaccines and Biomedicines supports Formycon's approach in the further development of FYB207. In particular, analytics, process development, manufacturing (so-called CMC-part: Chemistry-Manufacturing and Control), the preclinical development as well as the clinical concept of phases I and II, including the associated bioanalytical strategy, have been aligned. The review of the applications for the clinical trials is expected to be conducted in an accelerated process. All preclinical activities as well as preparations for entering clinical trials with FYB207 are progressing according to plan. In addition, Formycon is preparing a Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced German manufacturer.