Rani Therapeutics Holdings, Inc. announced the initiation of a Phase 1 clinical trial to evaluate the safety and tolerability of RT-111, an orally administered RaniPill® GO capsule containing an ustekinumab biosimilar, CT-P43. Topline results from this study are expected early in the first quarter of 2024. Ustekinumab is a human IgG1k' monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 (IL-12 and IL-23) cytokines, and is marketed in the United States by Janssen as STELARA®.

STELARA® is approved by the FDA for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn's disease, and moderate to severe ulcerative colitis, all of which have large unmet medical needs for oral treatment. Sales for STELARA® were approximately $6.4 billion in the United States and approximately $9.7 billion worldwide in 2022. Currently, ustekinumab is available only as a subcutaneous injection.

In preclinical testing of RT-111 in animal models, the RaniPill® delivered ustekinumab bioavailability comparable to subcutaneous injection. RT-111 is a convenient, oral delivery of ustekinumab via the RaniPill®® capsule. The first subject has been administered RT-111 in the single-center, open-label Phase 1 study, which is being conducted in Australia.

The study will evaluate the pharmacokinetics, safety and tolerability ofRT-111 administered in up to 55 healthy human participants. The trial will consist of three cohorts, with two cohorts evaluating RT-111 at a dose of 0.5mg or 0.75mg, administered as a RaniPill® capsule containing ustekinumab. The third cohort, as the control group, will receive Stelara® (ustekinumab) 0.5mg via subcutaneous injection.

The ustekinumab biologics used in RT-111 is manufactured and supplied by Celltrion Inc. under Rani's License and Supply Agreement with Celltrion announced in January 2023. Under that agreement, Celltrion exclusively supplies to Rani the ustekinumabiosimilar drug substance (CT-P43) required for RT-111. Rani is granted an exclusive license to use CT-43 in the development and commercialization of RT-111, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial that meets its primary endpoint(s).