Rani Therapeutics has developed an oral biologics device, named RaniPill HC, for the delivery of biologics.
The new device is capable of delivering a drug payload of up to or more than 500% higher compared to the company’s current oral biologics capsule.
A preclinical study of RaniPill HC has been conducted by the company, in which the device was administered to subjects with an 18mg dose of adalimumab.
In the study, the unencapsulated device was placed laparoscopically in the jejunum of three canine test subjects.
The device demonstrated successful delivery of adalimumab in all cases and also achieved high bioavailability in preclinical testing.
Over the course of five days, the systemic serum drug concentration was detected and measured.
Rani Therapeutics CEO Talat Imran said: “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.
“This sets the stage for the rest of the year, as we anticipate moving two programmes 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.”
Additionally, the company estimates a $13m to $15m net loss for the fourth quarter (Q4) of 2021, compared to $5.8m for the same quarter of 2020.
The net loss includes nearly $3.2m of estimated equity-based compensation expense for the quarter and approximately $22.6m for the complete year.