Yesterday, Celltrion and US-based Rani Therapeutics ("Rani") announced that they will jointly develop an oral formulation of CT-P43, a biosimilar to Stelara® (ustekinumab), indicated for the treatment of psoriasis, Crohn's disease, and ulcerative colitis. Celltrion's CT-P43 biosimilar is currently only available in two injectable formulations – intravenous and subcutaneous.
According to its website, Rani Therapeutics has developed "a 'robotic' pill that incorporates a number of innovations, enabling it to navigate through the stomach and enter the small intestine." Rani describes how its RaniPill" capsule is broken down by stomach acids before entering the small intestine and releasing soluble microneedles to inject a protein or antibody drug into the intestinal wall – "where there are no sharp pain receptors, so the injection is painless." Celltrion will exclusively supply CT-P43 to Rani for the non-clinical and phase 1 clinical trials of an oral formulation of ustekinumab with the potential to expand throughout its product pipeline.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.