- 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 -
“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
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
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the potential initiation of a Phase 1 trial of RT-105, Rani’s development and advancement of its RaniPill® HC and RaniPill® GO capsule technology, the ability to confirm reliability and optimize performance of the RaniPill® HC, the market opportunity for Rani utilizing the RaniPill® HC including the potential to enable Rani to address 90+ additional product candidates, customer acceptance of the RaniPill® capsule technology, the potential benefits of the RaniPill® capsule technology, and Rani’s growth as a company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “could,” “look forward,” “potential,” “enables,” “designed to,” “continue,” “anticipated,” “expected” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rani’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rani’s business in general and the other risks described in Rani’s filings with the
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