Celltrion said that Rani Therapeutics has reported positive topline results from its phase 1 clinical trial of RT-111, an oral form of ustekinumab.

The trial, conducted in Australia, involved 55 healthy adults and aimed to evaluate the pharmacokinetics (PK) and safety of RT-111, showcasing an impressive 84 percent bioavailability compared to the subcutaneous (SC) injection form of ustekinumab, with no serious adverse reactions observed.

RT-111 is being developed as an oral version of Celltrion’s Stelara biosimilar, CT-P43, marking a leap forward in patient convenience and potentially transforming the global market for ustekinumab treatments.

Stelara, developed by Janssen, is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals in the world, with IQVIA data showing that the treatment recorded $17.7 billion in sales in 2022.

Rani Therapeutics' proprietary RaniPill capsule technology, which delivers drugs similarly to injections via micro needles that dissolve in the small intestine, plays a crucial role in the development of RT-111.

The two companies believe that this approach could significantly enhance treatment adherence and patient experience by offering a non-invasive administration route.

Following these encouraging Phase 1 outcomes, Celltrion is set to discuss the exercise of a global development and commercialization license with Rani Therapeutics, building on an agreement that included a licensing and supply deal aimed at developing oral ustekinumab in January of last year.

"This clinical outcome represents the materialization of Celltrion's efforts to go beyond biosimilars and secure next-generation therapeutics," a company official said. “The company remains committed to innovating in the biopharmaceutical field, with ongoing projects in oral antibody therapies, antibody-drug conjugates (ADCs), new antibody medications, dual antibodies, and the microbiome.”