Celltrion Confirms Positive Results in Phase 1 Clinical Trial of Oral Stelara

Celltrion's 'oral antibody therapy' being developed with US-based Lani Therapeutics confirmed an effect comparable to existing injectable drugs in Phase 1 clinical trials.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

On the 6th, Celltrion announced that it confirmed positive top-line results in the Phase 1 clinical trial of 'RT-111,' an oral ustekinumab being developed by Lani. RT-111 is a candidate drug that Celltrion is developing orally based on 'CT-P43,' a biosimilar of the autoimmune disease treatment 'Stelara.'

This clinical trial, conducted in Australia, involved 55 healthy adults to evaluate the pharmacokinetics (PK) and safety of RT-111. As a result, RT-111 showed 84% bioavailability compared to the existing subcutaneous injection formulation of ustekinumab. Bioavailability refers to the proportion of an orally administered drug that reaches systemic circulation through the bloodstream. The company explained, "We demonstrated similar levels of pharmacokinetics" and "no serious adverse reactions were observed."

Based on these clinical results, Celltrion plans to negotiate with Lani to exercise the priority rights for global development and sales. In January last year, Celltrion signed a license and supply agreement with Lani for the development of oral ustekinumab. Through this, Celltrion secured priority negotiation rights for global development and sales depending on the Phase 1 clinical trial results.

Lani owns an independent oral capsule platform called ‘Lanipill.’ The oral capsules made using Lanipill technology can deliver drugs in a manner similar to existing injectables through micro-needles that dissolve inside the body when the capsule disintegrates in the small intestine.

Celltrion expects that if the oral formulation development of CT-P43 succeeds, it will dramatically improve patient administration convenience and secure differentiated competitiveness in the global ustekinumab market. Stelara, the original drug of CT-P43 developed by Johnson & Johnson (J&J), recorded global blockbuster sales of $10.86 billion (approximately 14.5 trillion KRW) last year. However, since only intravenous and subcutaneous injection formulations are currently available, there is a significant unmet demand for oral therapies.

A Celltrion official said, “These clinical results are a visible outcome of Celltrion’s efforts to secure next-generation therapies beyond biosimilars,” adding, “We will continue to secure innovative drug development technologies that can create synergy not only with biosimilar products but also with new drugs under development, and we will make every effort to achieve meaningful results.”

This content was produced with the assistance of AI translation services.