Revolutionizing Drug Delivery: Rani Therapeutics Launches Phase 1 Trial of RT-111 (RaniPill® Loaded with Ustekinumab Biosimilar, CT-P43)

SAN JOSE, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) — Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a trailblazing biotherapeutics company, is embarking on a Phase 1 clinical journey to explore the safety and tolerance of RT-111. This groundbreaking RaniPill®GO capsule contains an ustekinumab biosimilar, CT-P43, and could revolutionize drug delivery. Anticipate the eagerly awaited topline results in early Q1 2024.

Ustekinumab, a human IgG1қ monoclonal antibody, plays a vital role by targeting the p40 protein subunit shared by interleukin-12 and interleukin-23 (IL-12 and IL-23) cytokines. Janssen markets it as STELARA®, FDA-approved to tackle moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis—a lineup with substantial unmet medical needs for an oral solution. Remarkably, STELARA® generated around $6.4 billion in U.S. sales and approximately $9.7 billion globally in 2022.

Currently, ustekinumab is only available via subcutaneous injection. However, preclinical testing of RT-111 in animal models showcased the RaniPill® as an oral delivery method with bioavailability on par with subcutaneous injection.

Talat Imran, CEO of Rani, exclaimed, “This is a significant stride as we usher RT-111 into the clinical realm, bringing us closer to realizing our vision of accessible oral biologics for autoimmune disease patients. Conditions like psoriasis and psoriatic arthritis often require painful, frequent injections, which can be arduous. RT-111, encapsulated in the RaniPill®, offers a convenient oral alternative. What’s more, Rani’s drug-agnostic capsule technology opens doors to potentially replacing other injectable monoclonal antibodies and large molecules with oral options.”

The inaugural subject has received RT-111 in this open-label Phase 1 study, conducted in Australia. It will assess the pharmacokinetics, safety, and tolerance of RT-111 across up to 55 healthy volunteers. The trial features three cohorts: two exploring RT-111 at 0.5mg or 0.75mg doses, delivered through RaniPill® capsules containing ustekinumab, while the third cohort serves as a control group, receiving Stelara® (ustekinumab) 0.5mg via subcutaneous injection.

Notably, the ustekinumab biosimilar used in RT-111 is provided by Celltrion, Inc. (“Celltrion”), pursuant to the License and Supply Agreement between Rani and Celltrion, unveiled in January 2023. This agreement grants Rani exclusive rights to use CT-P43 in RT-111’s development and commercialization, while Celltrion secures a right of first negotiation for global RT-111 rights post a Phase 1 clinical trial with successful primary endpoint(s).

About Rani Therapeutics

Pioneering the Future of Drug Delivery: Rani Therapeutics is at the forefront of revolutionizing biologics and drug administration. Their game-changing technology, the RaniPill® capsule, is a cutting-edge, patented platform designed to usher in a new era of oral dosing, replacing the need for uncomfortable subcutaneous injections and intravenous infusions.

Rani is currently advancing two groundbreaking capsules, the RaniPill®GO and the RaniPill®HC. Their journey has been marked by successful preclinical and clinical studies, focusing on safety, tolerability, and bioavailability, all made possible by the innovative RaniPill capsule technology.

Forward-Looking Statements

Venturing into the Future: This press release is not just about facts; it’s about vision. Forward-looking statements underpin our journey, as we navigate uncharted territory. We’re talking about the exciting anticipation of topline results from the RT-111 Phase 1 study in early 2024, the potential for Celltrion to seize its right of first negotiation, and the broader horizon where RT-111 and the RaniPill® capsule technology may replace injectable monoclonal antibodies and large molecules with a convenient oral alternative.

It’s a world of opportunities we’re exploring, backed by our innovative RaniPill® capsule technology. But, as with any adventure, there are challenges along the way. We acknowledge that reality and understand that risks and uncertainties may impact our path. However, we’re committed to our vision and will continue to forge ahead. Stay tuned for the unfolding chapters of our journey!

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