RT-111 (ustekinumab biosimilar) / Rani Therap, Celltrion - LARVOL DELTA

ORALLY-ADMINISTERED USTEKINUMAB BIOSIMILAR DELIVERED VIA A ROBOTIC PILL YIELDS BIOAVAILABILITY COMPRABLE TO SUBCUTANEOUS INJECTION IN CANINES (DDW 2024) - "1) Maintenance of therapeutic serum ustekinumab levels may be superior with daily small doses compared to the current regimen of once every 1 weeks; and ) in canines the orally administered RP achieved serum bioavailability of ustekinumab comparable to that of SC injection demonstrating the feasibility of oral dosing. These data form the basis for the continued development of an oral alternative to injectable ustekinumab."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain

Rani Therapeutics to Present Clinical and Preclinical Data on Oral Delivery of an Ustekinumab Biosimilar via the RaniPill Capsule at Digestive Disease Week 2024 (GlobeNewswire) - "Rani Therapeutics Holdings, Inc...today announced that it will present clinical and preclinical and data on the RaniPill capsule, the company’s oral delivery platform, at Digestive Disease Week (DDW) taking place both virtually and in-person on May 18-21, 2024 in Washington, DC....Abstracts selected by the American Gastroenterological Association (AGA) for presentation at DDW will be available in a supplement to Gastroenterology."

P1 data • Preclinical • Immunology • Inflammation • Inflammatory Bowel Disease

Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111) (GlobeNewswire) - P1 | N=55 | NCT05890118 | Sponsor: RANI Therapeutics | "Rani Therapeutics Holdings, Inc...announced positive topline results from its Phase 1 clinical study of RT-111...In the study, RT-111 was well-tolerated and delivered ustekinumab with high bioavailability....Oral RT-111 delivered ustekinumab biosimilar in a dose proportional manner and with high bioavailability (estimated at 84% relative to subcutaneous injection). Oral RT-111 demonstrated a higher C_max and shorter T_max compared to ustekinumab delivered by SC injection (0.5mg)."

P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: RANI Therapeutics | Active, not recruiting ➔ Completed

Trial completion

Rani Therapeutics Holdings Inc (RANI) Reports Q3 2023 Financial Results and Corporate Developments (Yahoo Finance) - "The company has initiated a Phase 1 clinical trial for RT-111, a RaniPill GO containing an ustekinumab biosimilar, with results expected in the first quarter of 2024."

P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill Capsule (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: RANI Therapeutics | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Nov 2023 | Trial primary completion date: Apr 2024 ➔ Nov 2023

Enrollment closed • Trial completion date • Trial primary completion date

Rani Therapeutics Initiates Phase 1 Study of RT-111 (RaniPill Containing Ustekinumab Biosimilar, CT-P43) (GlobeNewswire) - "Rani Therapeutics Holdings, Inc...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....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."

P1 data • Trial status • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

Rani Therapeutics Reports Second Quarter 2023 Financial Results; Provides Corporate Update (GlobeNewswire) - "Initiation of Phase 1 study of RT-111 containing an ustekinumab biosimilar in the second half of 2023..."

New P1 trial • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule (clinicaltrials.gov) - P1 | N=55 | Not yet recruiting | Sponsor: RANI Therapeutics

New P1 trial

Rani Therapeutics Reports First Quarter 2023 Financial Results; Provides Corporate Update (GlobeNewswire) - "Announced partnership with Celltrion on development of an ustekinumab biosimilar for RT-111. In January 2023, Rani announced a partnership with Celltrion for the development of RT-111, a RaniPill GO capsule containing Celltrion’s ustekinumab biosimilar (CT-P43) for the potential treatment of psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis. Rani was granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, and Celltrion was granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial."

Licensing / partnership • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Rani Therapeutics Announces New RT-111 Development Program (GlobeNewswire) - "Rani announces preclinical development of RT-111, a RaniPill GO capsule containing ustekinumab biosimilar for the potential treatment of psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis...Initiation of three additional Phase 1 studies in 2023 with pipeline molecules - RT-105, RT-110 and RT-111."

New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis