Rani Therapeutics Announces Preclinical Data Demonstrating Bioequivalence Of RT-114, A GLP-1/GLP-2 Dual Agonist

- RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable PK profiles, meeting the primary endpoint of demonstrating bioequivalence –

- Both groups demonstrated comparable weight loss with less variability observed with RT-114 compared to subcutaneous PG-102 –

- Phase 1 clinical trial of subcutaneous PG-102 demonstrated weight loss in obese patients, with an average reduction of 4.8% and up to 8.7% following five weeks of dosing -

- Data bolster expanding body of evidence of the RaniPill® platform's potential to facilitate oral delivery of multiple obesity treatments including previously announced semaglutide -

- Phase 1 clinical study for RT-114 for the treatment of obesity expected to initiate in mid- 2025 -  

SAN JOSE, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. ("Rani Therapeutics" or "Rani") (NASDAQ:RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced pharmacokinetic and pharmacodynamic data from a preclinical study evaluating RT-114, a GLP-1/GLP-2 dual agonist (PG-102). PG-102 delivered orally via the RaniPill® capsule demonstrated comparable bioavailability and weight loss to subcutaneously (SC) injected PG-102 ("SC PG-102"). PG-102 is ProGen Co., Ltd's ("ProGen") Fc-fusion protein conjugated GLP-1/GLP-2 dual agonist.

"We believe that RT-114 has the potential to be a first-in-class, orally administered GLP-1/GLP-2 dual agonist for the treatment of obesity, addressing a critical gap in the treatment landscape. Despite the remarkable success of GLP-1 receptor agonists, there is a pressing need for effective oral therapies with convenient dosing strategies to eliminate the need for burdensome injections. With RT-114's extended half-life, we are targeting a convenient, oral dosing regimen for the treatment of obesity," said Talat Imran, Chief Executive Officer of Rani Therapeutics. "Furthermore, in our preclinical study, RT-114 achieved pharmacokinetics, bioavailability, and weight loss comparable to PG-102 delivered via subcutaneous injection. We believe that PG-102's GLP-1/GLP-2 dual agonist construct is key to its potential to induce higher quality weight loss, positioning RT-114 to potentially deliver improved body composition and nutritional health as an oral therapy. We are encouraged by the data generated to date and look forward to advancing RT-114 into a Phase 1 clinical trial this year."