Rani Therapeutics announced positive preclinical data for RT-114, an oral formulation of ProGen’s GLP-1/GLP-2 dual agonist, PG-102, for obesity treatment. The study demonstrated that orally delivered RT-114 achieved bioequivalence to subcutaneous PG-102, exhibiting comparable bioavailability and weight loss in canines. A Phase 1 clinical trial for RT-114 is anticipated to commence in mid-2025.
This development is potentially transformative for obesity management. Current GLP-1 receptor agonists, while effective, require injections, which can be a barrier for some patients. An oral formulation like RT-114 could significantly improve patient adherence and expand access to this class of treatments, thereby impacting public health. Furthermore, the dual GLP-1/GLP-2 mechanism of PG-102 may offer advantages in terms of body composition and nutritional health compared to existing GLP-1 therapies. Preclinical data suggests PG-102 may induce a faster onset of clinically meaningful weight loss, a notable improvement over current options which often take months to demonstrate substantial effects.
In the preclinical study, RT-114 achieved 111% relative bioavailability compared to subcutaneous PG-102, with a 90% delivery success rate using the RaniPill® capsule. Both oral and subcutaneous delivery resulted in similar average peak weight loss (6.7%), though the oral group exhibited less variability. Subcutaneous PG-102 has shown promising weight loss results (average 4.8%, up to 8.7% after five weeks) and tolerability in a Phase 1 trial involving 73 obese patients. Notably, there were no treatment discontinuations in this study. The collaboration between Rani and ProGen entails shared development costs and profits, with Rani leading initial development and North American/European commercialization, while ProGen focuses on other territories after Phase 2.
The positive preclinical data for RT-114 reinforces the potential of Rani’s RaniPill® platform to revolutionize drug delivery for biologics. A successful Phase 1 trial would further validate this technology and pave the way for the development of additional oral formulations of currently injectable medications. If RT-114 continues to demonstrate efficacy and safety in clinical trials, it could become a preferred treatment option for obesity, offering patients a convenient and potentially more effective alternative to injectable therapies. This advancement could significantly reshape the obesity treatment landscape and improve patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
