Rani Therapeutics Announces Preclinical Data Demonstrating Bioequivalence of RT-114, a GLP-1/GLP-2 Dual Agonist (PG-102) Delivered Orally via the RaniPill® Capsule, to Subcutaneously Administered PG-102

Core Insights - Rani Therapeutics has announced promising results for RT-114, an orally administered GLP-1/GLP-2 dual agonist, demonstrating bioequivalence to subcutaneously delivered PG-102 with a relative bioavailability of 111% [1][2][8] - The preclinical study showed comparable weight loss outcomes between RT-114 and SC PG-102, with RT-114 exhibiting less variability in weight loss results [1][4] - The company plans to initiate a Phase 1 clinical trial for RT-114 in mid-2025, furthering its commitment to developing oral therapies for obesity [1][9] Company Overview - Rani Therapeutics is focused on advancing oral delivery technologies for biologics and drugs, specifically through its proprietary RaniPill® capsule [10] - The company has successfully conducted multiple preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its oral delivery system [10] - RT-114 is part of a collaboration agreement with ProGen, aimed at developing and commercializing the drug for weight management [11] Clinical Data Highlights - In a preclinical study, RT-114 achieved a peak weight loss of 6.7% with a delivery success rate of 90% in canines, indicating strong pharmacokinetic and pharmacodynamic relationships [8] - The Phase 1 clinical trial of SC PG-102 showed an average weight loss of 4.8% and up to 8.7% after five weeks of dosing, demonstrating the drug's effectiveness in obese patients [3][4] - The pharmacokinetic data indicated that RT-114 had a Cmax of 1.51 µg/mL/kg and Tmax of 0.7 days, compared to SC PG-102's Cmax of 1.06 µg/mL/kg and Tmax of 1.3 days [7][8] Market Potential - RT-114 is positioned to fill a critical gap in the obesity treatment landscape by providing an effective oral alternative to existing injectable GLP-1 receptor agonists [2][4] - The convenience of an oral dosing regimen is expected to enhance patient compliance and address challenges associated with current GLP-1 treatment options [2][4]