Rani Therapeutics Announces Successful Drug Delivery of High-Capacity Pill in Preclinical Studies

Two preclinical studies of RaniPill® HC achieved 18/20 successful drug delivery of orally administered teriparatide resulting in a cumulative 90% success rate

Rani Therapeutics Holdings, a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, announced three new positive preclinical studies which support the development of a high-capacity oral biologics device known as the RaniPill^® HC, a version of the RaniPill^® capsule that is capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule.

“We are delighted to share that the orally administered RaniPill^® HC was able to demonstrate successful drug delivery and high reliability across multiple preclinical studies, further supporting our development of the RaniPill^® HC,” said Talat Imran, Chief Executive Officer of Rani. “The RaniPill^® HC is designed to enable the potential delivery of 90+ additional drug candidates, opening up a significant market opportunity for Rani Therapeutics. We are excited about the difference the RaniPill^® HC could make to alleviate the burden of painful injections for patients and provide a new solution for providers, and look forward to bringing the technology into the clinic through the initiation of a Phase 1 study of adalimumab RT-105.”

Preliminary Data Highlights:

Teriparatide Canine Studies

Rani conducted two preclinical studies of the RaniPill^® HC containing 40ug of teriparatide. In the first study, two RaniPill^® HC capsules were orally administered to 5 awake canine subjects sequentially, with a second RaniPill^® HC capsule administered after the deployment of the previous device was confirmed. In the second study, a single RaniPill^® HC capsule was administered to 10 awake canines.

• RaniPill^® HC achieved 18/20 successful drug delivery of teriparatide in the two studies, resulting in a cumulative 90% success rate.
• Successful drug delivery was confirmed by positive drug signal for teriparatide in serum.
• Devices used in these studies were separate iterations, and may not comprise all the same components expected in a final version.
• Preliminary preclinical testing supports the potential for RaniPill^® HC to have high reliability.

Rani also conducted an additional preclinical study of RaniPill^® HC containing Fe57 (iron) in 2 canine subjects.

• The RaniPill^® HC containing Fe57 showed a positive drug signal comparable to subcutaneous injection.
• Initial analysis of drug delivery via the RaniPill^® HC shows a potential for mimicking parenteral (subcutaneous) administration.

Anticipated Next Steps & Milestones:

• Continue preclinical testing of the RaniPill^® HC to confirm the preliminary reliability rate and optimize device performance.
• Introduce RaniPill^® HC into the clinic with the initiation of a Phase 1 trial of RT-105 containing adalimumab.

Published on : 08th September, 2023