– Daily administration for 60 days was well-tolerated with no treatment-related adverse events –
– Preclinical data support the safety and tolerability of RaniPill® capsule for subsequent clinical studies –
“The preclinical data announced today are highly encouraging and we believe these data further validate the safety and tolerability of our RaniPill® drug delivery platform,” said
Data Highlights
The preclinical GLP study evaluated the safety and tolerability of the RaniPill® drug delivery platform, following 60-day repeat oral administration of the test article, RT-100. RT-100 is an enteric-coated capsule identical to RT-102, but instead of teriparatide contains the pharmaceutical excipient mannitol. The control group received a capsule (Mock-RP) of similar weight to RT-100 but filled with potato starch.
The study included males and females (1:1) divided into two groups that were administered orally either a Mock-RP (N=12) or RT-100 (N=24) once daily for 60 consecutive days with half the animals completing an additional 14-day clinical observation and safety evaluation period. RT-100 was well-tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.
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 planned initiation of the RT-102 Phase II study in 2023, the potential for the data from the 60-day GLP study to validate the safety and tolerability of the RaniPill® drug delivery platform, the potential for the RaniPill® capsule technology to have application across a wide range of biologics, the ability of the data from the 60-day GLP study to bolster the safety database supporting the RaniPill® capsule and Rani’s pipeline programs, customer acceptance of the RaniPill® capsule technology, and the potential benefits of the RaniPill® capsule technology. 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 “believe,” “potential,” “plan,” “opportunity” 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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