– Topline results from this study are expected in early Q1 2024

– Celltrion has a right of first negotiation for RT-111 following positive Phase 1 results

SAN JOSE, CA, USA I September 18, 2023 I Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today 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 IgG1қ 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 biosimilar orally with bioavailability comparable to subcutaneous injection.

“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,” said Talat Imran, Chief Executive Officer of Rani. “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.”

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 of RT-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 biosimilar used in RT-111 is manufactured and supplied by Celltrion, Inc. (“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 (CT-P43) 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(s).

About Rani Therapeutics

Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani is progressing two RaniPill® capsules, the RaniPill®GO and the RaniPill®HC. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill capsule technology. For more information, visit ranitherapeutics.com.

SOURCE: Rani Therapeutics