Rani Therapeutics announces topline results from Phase 1 study of RT-111

Rani Therapeutics Holdings announces topline results from its Phase 1 clinical study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43. In the study, RT-111 was well-tolerated and delivered ustekinumab with high bioavailability. Ustekinumab is a human IgG1 monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 cytokines. Currently, ustekinumab is available only as a subcutaneous injection and is marketed in the United States by Janssen 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, 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. Rani‘s single-center, open label, Phase 1 study of RT-111 was conducted in Australia. The study evaluated the safety, tolerability, and pharmacokinetics of RT-111 in healthy adult volunteers. The study enrolled 20 participants each in RT-111 0.5mg and 0.75mg dose groups, and 15 participants in a STELARA 0.5mg subcutaneous injection group. Pharmacokinetics Oral RT-111 delivered ustekinumab biosimilar in a dose proportional manner and with high bioavailability. Oral RT-111 demonstrated a higher Cmax and shorter Tmax compared to ustekinumab delivered by SC injection. Safety and Tolerability: RT-111 was well-tolerated by all participants in the two RT-111 groups, and no serious adverse events were observed in the study. There was no meaningful difference in incidence of anti-drug antibodies via RaniPill route of delivery, compared to STELARA SC injection. No participants reported difficulty swallowing the capsule and capsule remnants passed from all participants without sequelae. The ustekinumab biosimilar used in RT-111 is manufactured and supplied by Celltrion, under Rani’s License and Supply Agreement with Celltrion announced in January 2023. Under that agreement, Celltrion exclusively supplies to Rani the ustekinumab biosimilar drug substance required for RT-111. Rani is granted an exclusive license to use CT-P43 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.