Rani Therapeutics Announces Successful Drug Delivery of High-Capacity Pill in Preclinical Studies
- Category: Proteins and Peptides
- Published on Friday, 08 September 2023 09:47
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- Two preclinical studies of RaniPill® HC achieved 18/20 successful drug delivery of orally administered teriparatide resulting in a cumulative 90% success rate
- Rani will continue preclinical testing to confirm preliminary reliability rate and optimize device performance
- Increased payload of up to 20mg enables potential delivery of 90+ additional drug candidates -
SAN JOSE, CA, USA I September 07, 2023 I Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today 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.
Fe57 Canine Study
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.
About Rani Therapeutics
Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani is progressing two RaniPill® capsules, the RaniPill® GO and the RaniPill® HC. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill® capsule technology. For more information, visit ranitherapeutics.com.
SOURCE: Rani Therapeutics