Rani Therapeutics Announces Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist
December 14 2023 - 8:00AM
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
pharmacodynamic data of an incretin triagonist of the GLP-1, GIP,
and glucagon receptors delivered transenterically, which mimics the
RaniPill route of administration. This follows Rani’s prior study
demonstrating oral delivery of a GLP-1 receptor agonist with high
bioavailability via the RaniPill capsule.
“The preclinical data announced today are highly
encouraging, as the data highlights that transenteric delivery
mimicking the RaniPill’s route of drug administration results in
pharmacodynamics comparable to subcutaneous injection for an
incretin triagonist,” said Talat Imran, Chief Executive Officer of
Rani Therapeutics. “In a previous preclinical study, Rani showed
that the RaniPill capsule can orally deliver a GLP-1 receptor
agonist with bioavailability and pharmacokinetics comparable to a
subcutaneous injection. In the recent study of an incretin
triagonist, Rani obtained pharmacodynamic data showing weight loss
and reduction in serum lipids comparable to that observed via the
subcutaneous injection route. We believe these data are reflective
of the potential contributions our RaniPill capsule can make to the
GLP-1 receptor agonist space and the broader obesity market. With
the RaniPill platform, we have the potential to create oral
alternatives for single and multiagonist drugs with differentiated
dosing flexibility. We are evaluating our options with an intention
to move forward with one or more products in this space.”
Data Highlights
The recent 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=5),
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
subcutaneous 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 is believed to be due to early
satiety leading to reduced caloric intake. The drug was well
tolerated in both groups with no serious adverse events (SAEs)
observed or changes in safety markers examined.
Near-Term Milestone
Expectations:
- Initiation of
Phase 2 clinical trial of RT-102, a RaniPill GO containing
teriparatide for osteoporosis, expected in 2024.
- Topline results
of Phase 1 clinical trial of RT-111, a RaniPill GO containing
ustekinumab biosimilar CT-P43, expected in the first quarter of
2024.
- Development of
RaniPill HC to be ready for potential Phase 1 clinical trials in
the second half of 2024.
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.
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
expected initiation of a Phase 2 clinical trial of RT-102 in 2024,
the potential opportunity for the RaniPill platform to support oral
delivery of multiple obesity drug products, the expected timing of
topline results from the RT-111 Phase 1 clinical trial in the first
quarter of 2024, the expected readiness of the RaniPill HC for
clinical development in the second half of 2024, the potential for
the transenteric delivery via endoscope of an incretin triagonist
to mimic the RaniPill route of delivery, 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 create oral alternatives for single and
multiagonist drugs with differentiated dosing flexibility. 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 “potential,”
“expected,” “believed” 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, 2022, 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.
Trademarks
Trade names, trademarks and service marks of
other companies appearing in this press release are the property of
their respective owners. Solely for convenience, the trademarks and
trade names referred to in this press release appear without the ®
and ™ symbols, but 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/fabfe920-addc-4e80-ad31-cdb2716763c2
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