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.

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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“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.