DGAP-News: Formycon AG / Key word(s): Study/Miscellaneous
Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)
- Vespucci study examines comparable efficacy, safety and immunogenicity of FYB202 and the reference product Stelara(R) in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
- Successful transfer of the third (late-stage) biosimilar candidate into a Phase III clinical trial
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris. This is the most common form of psoriasis, accounting for 80 to 90 percent of its occurrence, and is also known as plaque psoriasis. Due to this systemic disease affecting the entire body or organism, affected patients also have an increased risk of developing psoriatic arthritis and chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis.
The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide.
FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).
Formycon's COO Dr. Stefan Glombitza is pleased: "With the start of what is now our third clinical Phase III study, we have reached another milestone in the development of our (late-stage) biosimilar candidates. With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. We would also like to thank our partners for their constructive cooperation and look forward to further joint steps towards the approval of our high-quality Stelara(R) biosimilar."
* Stelara(R) is a registered Trademark of Johnson & Johnson
09.11.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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