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.
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.
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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