Rani Therapeutics Receives Feedback from Pre-IND Meeting with FDA; Provides Pipeline Update
January 05 2023 - 4:05PM
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 that it
completed a pre-Investigational New Drug (IND) meeting with the
U.S. Food and Drug Administration (“FDA”) with respect to RT-102,
the RaniPill™ GO containing a proprietary formulation of human
parathyroid hormone (1-34) analog (PTH) for the potential treatment
of osteoporosis, and provided a corporate update.
Pipeline Updates:
-
Preliminary feedback received from the FDA on future
development of RT-102. Following feedback from a pre-IND
meeting with the FDA, Rani believes that a 505(b)(2) pathway is
suitable for the development of RT-102 in the U.S. In addition,
Rani obtained guidance from the FDA on its preclinical and clinical
development plans for RT-102, including the Phase 2 clinical trial
which is expected to initiate in the second half of 2023.
-
Announced topline results from Phase 1 study of
RT-102. In December 2022, Rani announced positive topline
results from Part 2 (repeat-dose portion) of the Phase 1 study of
RT-102. RT-102 is being developed for the treatment of
osteoporosis. The study achieved all of its endpoints, with repeat
doses of RT-102 being generally well tolerated and delivering drug
with high reliability to participants via the RaniPill™ GO.
“We thank FDA for its feedback and helping us
chart the path forward for RT-102. As we enter 2023, Rani has
multiple upcoming clinical milestones that we believe could be
transformative for the company, including the initiation of a Phase
2 trial for RT-102 - our first Phase 2 trial - and the
initiation of three additional Phase 1 studies, including two
antibody programs,” said Talat Imran, Chief Executive Officer of
Rani. “We are delighted by the recent results from our RT-102
program, with positive Phase 1 single and repeat-dose data
reinforcing the potential of the RaniPill platform as an oral
delivery solution for biologics. We plan to carry this momentum
forward, and I look forward to providing further updates in coming
months.”
Near-Term Milestone
Expectations:
- RT-102 – Phase 2
initiation in the second half of 2023
- Initiation of
three additional Phase 1 studies in 2023 with pipeline molecules:
- RT-105
containing an adalimumab biosimilar
- RT-110
containing PTH for hypo-parathyroidism
- RT-111
containing an ustekinumab biosimilar for psoriatic arthritis,
ulcerative colitis, Crohn’s disease and psoriasis
Preliminary Unaudited Cash
Position:
- Rani has
approximately $99 million in cash, cash equivalents, restricted
cash equivalents and marketable securities as of December 31, 2022.
This estimate of the Company’s cash, cash equivalents, restricted
cash equivalents and marketable securities as of December 31, 2022
is preliminary, unaudited and is subject to change upon completion
of the Company’s financial statement closing procedures and the
audit of the Company’s consolidated financial statements.
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™ capsules, which are 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™ capsules. 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 trial of RT-102 in 2023, the
expected initiation of additional Phase 1 trials of other product
candidates in 2023, the impact achievement of upcoming clinical
milestones could have on the business of the Company, the potential
suitability of the 505(b)(2) pathway for RT-102 or other Rani
programs, the ability of the data from the Phase 1 study of RT-102
to support progressing to a Phase 2 trial of RT-102, and the
preliminary cash position of the 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 “may,” “could,” “anticipate,” “believe,”
“look forward,” “progress,” “advance,” “potential”, “be able to”
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, the impact of the COVID-19
pandemic, and the other risks described in Rani’s filings with the
Securities and Exchange Commission. 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.
Investor Contact:
investors@ranitherapeutics.com
Media Contact:
media@ranitherapeutics.com
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