BioFactura Starts Phase I Study of BFI-751, a Stelara Biosimilar

BFI-751 is a biosimilar designed to treat people with plaque psoriasis and psoriatic arthritis and other conditions.

BioFactura is set to begin a pivotal pharmacokinetics Phase 1 clinical trial for its Ustekinumab biosimilar BFI-751.

The first-in-human Phase I study will assess the effects on healthy human volunteers compared to the biologic medicine, Stelara. This is the first time BFI-751 has been administered to humans, as authorized by the Ethics Committees in both Australia and New Zealand.

The study is a bioequivalence randomized, double-blind, trial being conducted in Australia and New Zealand. The study’s primary purpose is to compare pharmacokinetics of 751-BFI to US-Stelara and EU-Stelara following a single dose under the skin.  It will also assess the safety and tolerability of BFI-751 in 210 healthy volunteers and their immune response.

The first three sentinel groups have been dosed with no significant adverse events reported to date. As such, the Safety Review Committee has recommended the study progress with the opening of all three clinical sites, in Adelaide and Brisbane, Australia, and Auckland, New Zealand, which are now accepting new volunteers for the trial.

“The initiation of this inaugural first-in-human study is an important milestone for BioFactura as it marks the beginning of clinical development of the first product candidate in our biosimilar pipeline,” says Dr. Darryl Sampey, BioFactura’s President and CEO, in a news release. “Drugs such as Stelara are optimally suited for biosimilar development employing our StableFastT technology which uniquely positions BioFactura for the future as we look to increase market share.” BioFactura is headquartered Maryland, USA.