ProGen and U.S.-based Rani Therapeutics announced on Monday that they have launched a Phase 1 clinical trial in Australia for their jointly developed oral obesity treatment, RPG-102 (designated RT-114 by Rani).
RPG-102 integrates ProGen’s dual-action Glucagon-Like Peptide (GLP)-1 and GLP-2 agent, PG-102, with Rani’s oral delivery platform, RaniPill.
PG-102 is a next-generation drug engineered to maintain the potent weight loss effects of existing GLP-1 medications while enhancing body composition and tolerability through GLP-2 action.
In preclinical beagle dog studies, RPG-102 demonstrated an average bioavailability exceeding 110% compared to injections, achieving weight loss effects comparable to injectable forms despite its oral formulation.
This breakthrough challenges the prevailing notion that oral GLP-1 treatments may be less effective than injections, suggesting that oral medications could potentially match the potency of injectables.
The Australian Phase 1 trial marks the first step in validating these preclinical findings in humans.
Part A of the study will compare the pharmacokinetics (PK) and bioavailability of a single dose of RPG-102 in healthy adults against injectable PG-102, assessing the feasibility of weekly dosing for the oral formulation.
Part B will involve administering RPG-102 to patients with a BMI of 30 or higher over eight weeks, evaluating safety, tolerability, and preliminary weight loss effects.
In a previous Phase 1 trial, injectable PG-102 achieved an average weight loss of 4.8% within five weeks in obese patients. The current trial aims to replicate or surpass this efficacy with the oral formulation.
Most oral GLP-1 treatments currently require daily dosing and are associated with gastrointestinal side effects.
RPG-102 aims to set new standards in oral obesity treatments by offering stronger weight loss effects and improved tolerability through a weekly dosing regimen. This approach goes beyond simply converting injections to oral forms, potentially redefining efficacy, dosing intervals, and tolerability benchmarks for oral obesity medications.
ProGen has completed dosing for the Phase 2 clinical trial of injectable PG-102 in obese patients and is analyzing the data. Results from this trial, along with Phase 1 findings for oral RPG-102, are expected to be released later this year.
ProGen Chief Executive Officer (CEO) Kim Jong-kyun commented that while the obesity treatment landscape is rapidly shifting towards oral GLP-1 agents, significant challenges remain in tolerability and long-term adherence. It believes RPG-102, with its weekly oral dosing based on the highly tolerable PG-102, could dramatically improve patient experience while maintaining efficacy.
He added that this Australian Phase 1 trial will explore the potential of weekly oral administration and comprehensively demonstrate the versatility of the PG-102 platform across both injectable and oral formulations.