Rani Therapeutics Holdings Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, has entered into a definitive agreement with ProGen Co. Ltd., a South Korean clinical-stage biotech company developing next-gen long-acting, multi-specific fusion protein therapeutics, for the co-development and commercialization of RT-114, an oral RaniPill capsule containing ProGen’s PG-102, a GLP-1/GLP-2 dual agonist, for the treatment of obesity.
 
The RaniPill capsule is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. To date, Rani has completed three Phase 1 clinical studies with the RaniPill capsule. Additionally, ProGen’s preclinical studies demonstrated that treatment with PG-102 resulted in greater glycemic control while inducing a similar degree of body weight loss versus semaglutide and tirzepatide.
 
ProGen recently presented results from its Phase 1 single-ascending dose study of PG-102, a GLP-1/GLP-2 dual agonist, at the 2024 American Diabetes Association conference in which PG-102 showed a favorable safety profile with lower frequencies of gastrointestinal (GI) side effects compared to competitors’ trials in similar settings.
 
Additionally, the PK/pharmacodynamic (PD) data from this trial and preclinical studies support potential dosing of RT-114 on a weekly to monthly schedule, which could improve patient compliance.
 
“This collaboration with ProGen reinforces Rani’s clear commitment to improving the lives of people suffering from chronic conditions, such as obesity, by replacing painful injections with the convenience of a pill,” said Talat Imran, CEO of Rani Therapeutics. “We chose to collaborate with ProGen based on the potentially unique pharmacokinetic (PK) and tolerability profile of PG-102 in a RaniPill capsule. Given the long half-life of PG-102, the parties intend to pursue development of RT-114 as a convenient, weekly oral dose. It also has the potential to improve body composition and nutritional health of patients owing to the unique mechanism of action of GLP-2.”
 
“This partnership brings together Rani’s oral biologics delivery expertise with ProGen’s two decades of experience in Fc-fusion proteins to enable development of a potentially unique oral therapy option for people with obesity,” said Dr. Jong-Gyun Kim, CEO of ProGen. “Together, we are focused on pursuing RT-114 as a potential first-in-class, oral dual agonist in the anti-obesity arena.”
 
Under the terms of the collaboration agreement, Rani and ProGen agree to share responsibilities for the development and commercialization of RT-114 worldwide, including a 50/50 cost and revenue share arrangement. Rani has exclusive rights to lead development and commercialization of RT-114 in the United States, Europe, Canada and Australia, and ProGen has exclusive rights to lead development and commercialization in the rest of the world. Each party has certain rights to sublicense in its territories.
 
Rani is designated to lead operationally in conducting preclinical and development activities through the Phase 1 program, which is expected to initiate in 2025. As part of this agreement, there is no upfront payment or financial exchange between the companies.