BioFactura has specialized in biodefense agents for smallpox and Marburg virus, but sees revenue potential in biosimilars.
Frederick, Maryland–based BioFactura has begun a phase 1 clinical trial for an ustekinumab biosimilar candidate (BFI-751). The prospective biosimilar references Stelara (Janssen Biotech), an immunosuppressant for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
The phase 1 trial will compare the pharmacokinetics of BFI-751 with US and EU versions of Stelara following a single subcutaneous dose administered to healthy volunteers. The randomized, double-blind study will assess safety, tolerability, and immune response.
“The first 3 sentinel groups have been dosed with no significant adverse events reported to date,” BioFactura said in a statement. The study will continue with the opening of clinical sites in Adelaide and Brisbane, Australia, and Auckland, New Zealand.
Darryl Sampey, PhD, president and CEO, said this is BioFactura’s first biosimilar clinical trial. Previously, the company has worked on biodefense, such as engineering drugs for emergency treatment of smallpox and Marburg virus (related to Ebola) outbreaks. Janssen reported $5.24 billion in Stelara revenues in 2020, up from $4.35 billion the year before.