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Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara* in Phase III Study

DGAP-News: Formycon AG / Key word(s): Study results/Study Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara* in Phase III Study 16.08.2022 / 07:30 CET/CEST The issuer is solely responsible for the content of this announcement. Press Release // August 16, 2022

  

Formycon’s Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara* in Phase III Study

• VESPUCCI study demonstrates the comparable efficacy of FYB202 to the reference product Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
• Primary Efficacy Endpoint of the Global Phase III Study met
• Comparative Phase I Pharmacokinetics Study in recruitment

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara(Ustekinumab).

The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). This is the most common form of psoriasis, accounting for 80 to 90 percent of all cases.

The primary endpoint of the comparative global Phase III study measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. The values obtained for FYB202 and reference product are within the relevant equivalence limits. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed.

The extended Phase I pharmacokinetics study has commenced. Recruitment is evolving according to plan and a substantial number of subjects has already been enrolled in the study.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara achieved a global sales volume of over USD 9 billion in 2021.