Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.
FYB202 is being developed in a joint venture by Aristo Pharma GmbH and Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%. Bioeq GmbH is the sponsor of the clinical trial and is also responsible for the study design and clinical operation.
Provided successful completion of clinical Phase I and subsequent Phase III testing and timely regulatory approval, FYB202 can be launched after patent expiry of Stelara® (USA 09/2023; EU 07/2024).
* Stelara® is a registered trademark of Johnson & Johnson.