BioFactura, a leading developer of high-value biosimilar and biodefense drugs using its patented StableFast platform, announced an agreement with Rani to assess its Ustekinumab biosimilar (BFI-751) in combination with Rani’s RaniPill platform.
BFI-751 is being developed by BioFactura Australia, a subsidiary of BioFactura, as a biosimilar drug to Stelara (ustekinumab), a biologic medication used to treat people diagnosed with Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Stelara is an immunosuppressant that reduces the effects of inflammatory proteins within the body. BFI-751 employs BioFactura’s StableFast technology, a novel platform that allows for the faster generation of fingerprint-like copies of the targeted reference drug.
[Read more: FDA approves new indication for Janssen's Stelara]
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.
The RaniPill capsule is designed to be a pain-free alternative for delivering large molecule chronic disease treatments that are typically administered via injection. Rani will conduct preclinical studies to determine whether BFI-751 can successfully be delivered into the bloodstream, when administered orally via the RaniPil capsule.
“With the prevalence of autoimmune diseases across the globe, it is important to provide new options to treat patients in innovative ways," said Dr. Darryl Sampey, BioFactura’s president and CEO. "The combination of BFI-751 and Rani’s delivery platform could provide an alternative treatment for debilitating disorders and improve patient compliance with an easy-to-swallow option.”
[Read more: Amgen gets FDA nod for biosimilar Remicade]
Dr. Jeffrey Hausfeld, chief medical officer and chairman of the BioFactura board of directors said, “It’s very exciting being on the cutting edge of technology. Bringing together our Stelara biosimilar with Rani's oral platform is a good example of BioFactura’s mission to continuously innovate, provide patients with high quality products, and offer improved value and accessibility.”