Rani Therapeutics Reports Positive Initial Phase 1 Data For RT-114

(RTTNews) - Rani Therapeutics Holdings, Inc. (RANI) on Wednesday reported positive initial data from the Phase 1 study of RT-114, an orally administered RaniPill Capsule delivering PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen Co., Ltd.

The initial data demonstrated that oral RT-114 achieved systemic exposure exceeding that of matched subcutaneous administration, with a safety and tolerability profile consistent with the GLP-1/GLP-2 agonist class of therapeutics.

No serious adverse events were reported, and treatment-related side effects, including nausea, vomiting and diarrhea, were mild and transient. The elimination half-life was similar between oral RT-114 and subcutaneous PG-102.

Following the results, Rani is adding a new Phase 1a cohort to further evaluate the oral-to-subcutaneous pharmacokinetic relationship and support dose selection for a planned Phase 1b obesity study, expected to begin in 2026 with data anticipated in 2027.

Rani Therapeutics and ProGen are jointly developing RT-114 under a collaboration agreement that shares development costs and future revenues equally.

Rani Therapeutics shares rose more than 2% in pre-market trading after closing at $0.6490 on Tuesday.