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 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, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- 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