Rani Therapeutics has initiated a Phase I clinical trial of RT-111, a RaniPill GO capsule containing ustekinumab biosimilar CT-P43.
The open-label, single-centre study, being carried out in Australia, is designed to assess the safety, tolerability, and pharmacokinetics of RT-111 in healthy subjects.
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It intends to enrol nearly 55 participants who will be divided into treatment group of two cohorts and the control group with one cohort.
Two cohorts will receive RT-111 0.5mg or 0.75mg as a RaniPill capsule, while one cohort will be given Stelara (ustekinumab) 0.5mg subcutaneous injection.
In the trial, the first subject received the dosage.
Rani Therapeutics CEO Talat Imran said: “We are thrilled to announce the advancement of RT-111 into the clinic, an important milestone for Rani which brings us one step closer to our goal of making oral biologics a reality for patients with autoimmune diseases.
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By GlobalData“Psoriasis, psoriatic arthritis and other autoimmune conditions are chronic diseases that can require regular, painful injections that are burdensome for patients.
“RT-111 is a convenient, oral delivery of ustekinumab via the RaniPill capsule. Moreover, because the RaniPill capsule technology is a drug-agnostic delivery platform, RT-111 also represents a broader opportunity to potentially replace other injectable-only monoclonal antibodies and large molecules with an oral alternative.”
Topline results from the study are anticipated in the early first quarter of next year.
CT-P43 is supplied to Rani by Celltrion, as part of the license and supply agreement signed between the two companies this January.
Rani gained an exclusive licence to use CT-P43 during the development and marketing of RT-111 while Celltrion has a right of first negotiation to acquire global rights for RT-111, following positive Phase I results.
In the US, the human IgG1қ monoclonal antibody ustekinumab is marketed by Janssen as STELARA.
Ustekinumab binds to the p40 protein subunit, used by the interleukin-12, as well as interleukin-23 cytokines.
