Rani Therapeutics Holdings Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has developed a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule.
 
In preclinical testing, RaniPill HC demonstrated successful delivery of adalimumab and achieved high bioavailability.
 
“The RaniPill HC gives us the potential to deliver a much broader range of biologic drugs with its higher capacity of up to 20mg of drug per capsule,” said Mir Imran, Rani’s founder and executive chairman. “In addition, since the RaniPill HC shares many similarities with our existing RaniPill capsule, we are confident in our ability to achieve similar safety and performance metrics, and to leverage our existing investments in manufacturing and automation.”
 
Today, biologics are predominantly delivered via injection or intravenous infusion, which limits long-term treatment adherence, often leading to suboptimal patient outcomes. An equally effective oral alternative could change the treatment paradigm for a number of patient populations, including those with autoimmune diseases, cancer and diabetes.
 
“Therapeutic drug development has yielded a vast array of molecular entities, including peptides, antibodies and oligonucleotides. The new technology from Rani now allows for the potential oral administration of these drugs irrespective of their size or chemical nature,” said Dr. Dennis Ausiello, a member of Rani’s Board of Directors. Dr. Ausiello is the director of the Center for Assessment Technology & Continuous Health (CATCH) and was previously chief of medicine at Massachusetts General Hospital.

About the Study

Rani conducted a preclinical study of RaniPill HC, with each device containing an 18mg dose of the biologic adalimumab, a tumor necrosis factor (TNF)-α inhibitor that is approved for multiple autoimmune conditions including rheumatoid arthritis and Crohn’s disease. The unencapsulated RaniPill HC device was placed laparoscopically in the jejunum of each of three canine test subjects and allowed to self-deploy under observation. Successful delivery was achieved in all cases, and systemic serum drug concentration was detected and measured over five days.
 
“The RaniPill HC is a major milestone for our platform technology. It opens up a significant number of opportunities for new pipeline drugs and partnerships,” said Talat Imran, Rani’s CEO. “This sets the stage for the rest of the year, as we anticipate moving two programs into the clinic using our existing RaniPill capsule, while also advancing development of the RaniPill HC for high-dose biologics. We believe these technologies have the potential to improve the lives of millions of patients with chronic diseases who currently depend on frequent injections.”