Rani Therapeutics Initiates Phase 1 Study of RT-111 (RaniPill Containing Ustekinumab Biosimilar, CT-P43)

- 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, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- 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 RaniPillGO 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.”