Celltrion enters phase 1 trial for oral formulation of autoimmune therapy

[Courtesy of Celltrion]

South Korea’s Celltrion is extending its reach beyond the realm of biosimilars to become a biopharmaceutical company that encompasses novel drug discovery and development.

The company is engaged in open innovation with domestic and foreign companies in various fields, including antibody drug conjugates (ADCs), microbiomes, and anti-viral platforms, and has made progress in the field of oral antibody therapeutics for the first time.

Celltrion announced on Tuesday that Rani Therapeutics, its U.S. biotech partner, has initiated a phase 1 clinical trial for RT-111, the oral formulation of Celltrion’s CT-P43.

CT-P43 is a biosimilar version of ustekinumab treating autoimmune diseases.

“We believe that Rani’s platform holds potential for application across various pipelines, and we will assess the possibility of expanding our collaboration based on the clinical results,” a Celltrion spokesperson said.

Rani Therapeutics is conducting a phase 1 clinical trial in Australia involving up to 55 participants to evaluate ustekinumab’s pharmacokinetics and safety in its oral format. The topline results of the study are expected to be available in the first quarter of 2024. Depending on the phase 1 results, Celltrion will be eligible for preferential negotiation rights for the drug’s global development and commercialization.