Rani Therapeutics Announces New Preclinical Pharmacokinetic Data Supporting Transenteric Delivery of GLP-1 Incretin Triagonist
2024年10月17日 - 9:00PM
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 new
pharmacokinetic data from a preclinical study evaluating a GLP-1,
GIP and glucagon receptors incretin triagonist with a delivery
method mimicking the RaniPill route of administration. A previous
study with this incretin triagonist delivered transenterically
demonstrated pharmacodynamic effects comparable to subcutaneous
injection. Rani also previously completed a study demonstrating
oral delivery of GLP-1 receptor agonist with high bioavailability
via the RaniPill capsule.
“The pharmacokinetic data announced today
combined with the previously announced pharmacodynamic data further
highlight the RaniPill’s potential to serve as a novel delivery
platform for incretin triagonists, a next generation modality for
the treatment of obesity,” said Talat Imran, Chief Executive
Officer of Rani Therapeutics. “Overall, the totality of RaniPill
preclinical data presented to date is promising and provides
scientific validation for the potential of the RaniPill to replace
painful injections with oral alternatives with differentiated
dosing flexibility for multiple obesity drug candidates. Looking
ahead, we are focused on execution of a Phase 1 clinical trial for
RT-114, a RaniPill capsule containing ProGen’s GLP-1 / GLP-2
dual-agonist, PG-102, and we are evaluating options to move forward
with one or more additional molecules in the obesity space.”
Data Highlights
The preclinical study evaluated the
pharmacokinetic (PK) and pharmacodynamic (PD) profiles of an
incretin triagonist (GLP-1, GIP, glucagon receptors) when delivered
via an endoscope-guided transenteric administration to mimic the
RaniPill route of administration, versus the traditional
administration route of subcutaneous (SC) injection. The study was
conducted in canines separated into two groups. In Group 1 (N=3),
0.12 mg/kg of drug was administered via transenteric delivery by
endoscope. In Group 2 (N=5), 0.12 mg/kg of drug was administered by
SC injection. Blood samples were collected over 2 weeks for
analysis of serum drug concentrations and various PD and safety
biomarkers.
A single dose of drug delivered via either
transenteric or SC routes elicited rapid decreases in body weight
and serum lipids. Weight loss observed following transenteric
delivery was 9.7 ± 2.5 % versus 6.9 ± 2.1 % following SC injection
and is believed to be due to early satiety leading to reduced
caloric intake. Additionally, the bioavailability of drug delivered
via the transenteric route was comparable to that of drug delivered
via the SC route at the same dose. The drug was well tolerated in
both groups with no serious adverse events (SAEs) observed or
changes in safety markers examined.
Transenteric delivery via the RaniPill yielded
80% relative bioavailability versus SC and differences between PK
parameters (AUC, Cmax, Tmax) were not statistically
significant.
|
AUC (nmol*h/L) |
Cmax
(nmol/L) |
Tmax (h) |
Transenteric |
26963.3 ± 5520.0 |
334.3 ± 32.8 |
16.7 ± 10.4 |
SC |
33509.5 ± 1576.1 |
311.5 ± 26.1 |
24 ± 0.0 |
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 has successfully conducted several preclinical and
clinical studies to evaluate safety, tolerability and
bioavailability using RaniPill® capsule technology. For more
information, visit ranitherapeutics.com.
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 opportunity for the RaniPill platform to enable
oral delivery of multiple obesity drug products, the potential for
the transenteric delivery via endoscope of an incretin triagonist
to mimic the RaniPill route of delivery, the expected initiation of
a Phase 1 trial of RT-114 in 2025, the potential for the RaniPill
to serve as a novel delivery platform for incretin triagonists, the
likelihood that weight loss in the preclinical study of the
incretin triagonist was caused by early satiety leading to reduced
caloric intake, the belief that the preclinical data are reflective
of the potential contributions the RaniPill capsule can make to the
GLP-1 receptor agonist space and the broader obesity market, and
the potential for Rani to use the RaniPill platform to replace
painful injections with oral alternatives with differentiated
dosing flexibility for multiple obesity drug candidates. 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 “believed,”
“potential,” “expected,” “looking ahead,” “intended” 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
Securities and Exchange Commission, including Rani’s annual report
on Form 10-K for the year ended December 31, 2023, and subsequent
filings and reports by Rani. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. Rani undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
TrademarksTrade names,
trademarks and service marks of other companies appearing in this
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for convenience, the trademarks and trade names referred to in this
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those references are not intended to indicate, in any way, that we
will not assert, to the fullest extent under applicable law, our
rights, or the right of the applicable licensor to these trademarks
and tradenames.
Investor
Contact:investors@ranitherapeutics.com
Media
Contact:media@ranitherapeutics.com
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Rani Therapeutics (NASDAQ:RANI)
過去 株価チャート
から 11 2024 まで 12 2024
Rani Therapeutics (NASDAQ:RANI)
過去 株価チャート
から 12 2023 まで 12 2024