On December 14, 2023, Rani Therapeutics Holdings, Inc. announced preclinical data regarding a unimolecular triagonist molecule delivered via endoscope and an update regarding timing of the initiation of its RT-102 Phase 2 clinical study. Data Highlights: The recent preclinical study evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of an incretin triagonist (GLP-1, GIP, glucagon receptors) when delivered via endoscope-guided transenteric administration to mimic the RaniPill route of administration, versus the traditional administration route of subcutaneous (SC) injection. The study was conducted in canines separated into two groups.

In Group 1 (N=5), 0.12 mg/kg of drug was administered via transenteric delivery by endoscope. In Group 2 (N=5),0.12 mg/kg of Drug was administered by subcutaneous injection. Blood samples were collected over 2 weeks for analysis of serum drug concentrations and various PD and safety biomarkers.

A single dose of drug delivered via either transenteric or SC routes elicited rapid decreases in body weight and serum lipids. Weight loss is believed to be due to early satiety leading to reduced caloric intake. The drug was well tolerated in both groups with no serious adverse events (SAEs) observed or changes in safety markers assessed.

Peak Decreases in Body Weights: Group 1: Endoscopic (N=5); Group 2: SC (N=5). All data are Means SE: Near-Term Milestone expectations: initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected in 2024. Topline results of Phase 1 clinical trial of RT-111, a RaniPillGO containing ustekinumab biosimilar CT-P43, expected in the first quarter of 2024.

Development of RaniPill HC to be ready for potential Phase 1 clinical trials in the second half of 2024.