BFI-751 (ustekinumab biosimilar) / BioFactura, Aurobindo - LARVOL DELTA

Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial. (PubMed, Clin Pharmacol Drug Dev) - P1 | "There were no marked differences in the safety and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups."

Journal • P1 data • PK/PD data

Aurobindo Pharma arm gets exclusive rights for monoclonal antibody ustekinumab's biosimilar (CNBC-TV18) - "Drug major Aurobindo Pharma Ltd...said its wholly-owned subsidiary CuraTeQ Biologics Private has signed an exclusive licence agreement with the US-based BioFactura to commercialise BFI-751, a proposed biosimilar to Stelara (ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used for treating Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

BioFactura’s Biosimilar Ustekinumab, Demonstrates Pharmacokinetic (PK) Bioequivalence to Stelara in Phase 1 Study (EIN News) - P1 | N=216 | NCT04843631 | Sponsor: BioFactura Australia Pty Ltd. | "BioFactura Inc. has announced today the completion of the pivotal pharmacokinetic comparability clinical trial for its Ustekinumab Biosimilar (BFI-751). The clinical trial was conducted in two sites in Australia and one site in New Zealand. BioFactura developed BFI-751 using its proprietary NS0 host cell line-based StableFastTM Biomanufacturing Platform....Pairwise comparisons between the three treatments all met the standard bioequivalence criteria that the 90% CI (Confidence Interval) of the geometric mean ratios of AUCinf, AUC0-tlast and Cmax of Ustekinumab lay completely within the acceptance interval of 80% - 125%. Clearance and elimination rates were shown to be comparable across the three treatment arms. Secondary endpoints met included no marked differences in the safety and tolerability profile for subjects receiving BFI-751 as compared to EU- or US-STELARA®."

P1 data • Immunology • Psoriasis

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults (clinicaltrials.gov) - P1 | N=216 | Completed | Sponsor: BioFactura Australia Pty Ltd. | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

BioFactura Announces Material Transfer Agreement with RANI Therapeutics (EIN News) - "BioFactura Inc...announces an agreement with Rani Therapeutics ('Rani') to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform....Under terms of the material transfer agreement, Rani has agreed to evaluate BFI-751 in its RaniPill™ capsule, a novel, proprietary and patented platform technology, intended to replace subcutaneous or IV injection of biologics with oral dosing....Rani will conduct preclinical studies to determine whether BFI-751 can successfully be delivered into the bloodstream, when administered orally via the RaniPill™ capsule."

Licensing / partnership • Immunology • Psoriasis

BioFactura Announces Initiation of Phase I Study of BFI-751, a Stelara (ustekinumab) Biosimilar (Businesswire) - "BioFactura...announces today the initiation of a pivotal PK (pharmacokinetics) Phase 1 Clinical Trial for its Ustekinumab Biosimilar (BFI-751), to assess the effects on healthy human volunteers compared to the biologic medicine, Stelera®. This is the first time BFI-751 has been administered to humans, as authorized by the Ethics Committees in both Australia and New Zealand...BFI-751...is a prescription biologic medicine used to treat people with Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis."

Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults (clinicaltrials.gov) - P1; N=228; Recruiting; Sponsor: BioFactura Australia Pty Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults (clinicaltrials.gov) - P1; N=228; Not yet recruiting; Sponsor: BioFactura Australia Pty Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis