Celltrion announced on Feb. 6 that Rani Therapeutics (Rani) in the United States has confirmed positive topline results in the Phase 1 clinical trial of oral ustekinumab (development name: RT-111). RT-111 is an oral formulation of Celltrion’s Stelara biosimilar, CT-P43, currently under development.
In this clinical trial conducted in Australia, RT-111’s pharmacokinetics (PK) and safety were confirmed in 55 healthy adults. According to the clinical results, the oral RT-111 demonstrated a significantly higher bioavailability of 84 percent compared to the subcutaneous injection formulation of ustekinumab. Additionally, it proved similar PK and no serious adverse reactions were observed.
Following the successful outcome of this clinical trial, Celltrion plans to initiate the process of exercising the right of first offer for global development and sales (global license) through discussions with Rani. In January, Celltrion signed a license and supply agreement with Rani for the development of oral Ustekinumab and secured the right of first offer for global development and sales based on the Phase 1 clinical trial results.
Rani possesses an exclusive oral capsule platform called “RaniPill.” Oral capsules created using RaniPill technology are designed to dissolve in the small intestine, releasing micro-needles that dissolve within the body to deliver medication in a manner similar to injections.
Celltrion expects that the development of CT-P43 as an oral formulation will significantly improve patients’ medication convenience and secure differentiated competitiveness in the global ustekinumab market. The original drug for CT-P43, Stelara, is an interleukin (IL)-12 and IL-23 inhibitor. It is used for indications such as plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis. Currently, it is available in two formulations: intravenous (IV) and subcutaneous (SC) injections. There is a significant unmet medical demand for oral treatments in these therapeutic areas.
Celltrion is advancing beyond biosimilars to secure next-generation therapies, aiming to establish itself as a pharmaceutical company focused on innovative drug development. To achieve this goal, Celltrion is conducting independent development and collaborations across various fields, including oral antibody therapies, antibody-drug conjugates (ADC), novel antibodies, bispecific antibodies, and microbiome research.