RT-111 is a capsule containing ustekinumab biosimilar CT-P43, marketed by Johnson & Johnson as subcutaneous Stelara. Credit: Ridofranz via Getty Images.

US-based Rani Therapeutics has announced positive topline data from the Phase I clinical study (NCT05890118) of RT-111, an ustekinumab biosimilar in development for the treatment of psoriasis. 

Comprising ustekinumab biosimilar CT-P43 housed in a RaniPill capsule, RT-111 uses ‘robotic’ technology to inject the drug through the intestinal wall, in a non-invasive and painless drug delivery process. 

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The open-label, single-centre study evaluated the safety, tolerability, and pharmacokinetics of RT-111 in healthy subjects across three cohorts. The active comparator group was given a 0.5mg subcutaneous injection of Stelara (ustekinumab) while the other two cohorts received 0.5mg or 0.75mg of RT-111. In the 55-patient cohort, the primary endpoints of pharmacokinetics and safety were met, with no serious adverse events reported in the study. 

The ustekinumab biosimilar CT-P43 was supplied to Rani by Celltrion after Rani signed a licence and supply agreement with Celltrion for the drug in January 2023. The agreement grants Celltrion the first negotiation for the worldwide rights to the drug. 

In the US, the human IgG1қ monoclonal antibody ustekinumab is marketed by Johnson & Johnson (J&J) as Stelara for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis. 

Earlier this month, STADA and Alvotech won the first EU approval for its Stelara biosimilar Uzpruvo (AVT04), opening the door for more competition to enter the regional ustekinumab market. In addition, Amgen scored the first US Food and Drug Administration (FDA) for its interchangeable biosimilar version of Stelara, dubbed Wezlana (ustekinumab-auub) in November 2023.  

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J&J’s Supplementary Protection Certificate (SPC) for Stelara is set to expire on 19 July 2024. SPC protect intellectual property as an extension of patent rights. Stelara generated $10.9bn worldwide in 2023, according to J&J’s 2023 annual report. GlobalData anticipates that sales of Stelara will drop to $2.5bn in 2029 as competition from biosimilars decreases sales. 

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