First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
02 Ottobre 2024 - 2:00PM
Business Wire
- Anticipated advantages of UGN-103 include a shorter
manufacturing process and a simpler reconstitution procedure
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced that the first
patient was dosed in the Phase 3 clinical trial of investigational
drug UGN-103 (mitomycin) for intravesical solution in development
for the treatment of low-grade intermediate-risk non-muscle
invasive bladder cancer (LG-IR-NMIBC). UGN-103 is a next-generation
novel mitomycin-based formulation.
“Reaching this Phase 3 trial milestone for UGN-103 highlights
our drive to innovate and bring forward cutting-edge treatments for
low-grade intermediate-risk non-muscle invasive bladder cancer,”
said Liz Barrett, President and Chief Executive Officer, UroGen.
“UGN-103 represents a significant step forward, offering potential
improvements in manufacturing, convenience, and cost. We are
excited about the potential of this next-generation formulation and
look forward to furthering its development to advance the care of
patients.”
The UGN-103 formulation uses UroGen’s RTGel® platform
technology, a proprietary sustained-release, reverse-thermal
hydrogel with the potential to improve the therapeutic profiles of
existing drugs. The U.S. Food and Drug Administration (FDA)
accepted the Investigational New Drug Application for UGN-103 in
April 2024, permitting the drug’s investigational use in adults
with LG-IR-NMIBC, a highly recurrent disease. UGN-103 is planned to
follow the potential FDA approval and launch of UGN-102 (mitomycin)
for intravesical solution for LG-IR-NMIBC. UroGen completed the New
Drug Application (NDA) submission for UGN-102 ahead of schedule
with potential FDA approval in early 2025, if the NDA is accepted
for filing by the FDA and priority review is granted.
The UTOPIA study is a single-arm, multicenter study that will
evaluate the efficacy and safety of UGN-103. UroGen is aiming to
enroll 87 patients with LG-IR-NMIBC in the UTOPIA study. Patients
will receive 75 mg of UGN-103 via intravesical instillation once a
week for 6 weeks. Efficacy will be assessed by the complete
response rate at the three-month visit. Patients who have a
complete response at the three-month visit, defined as having no
detectable disease in the bladder, will enter the follow-up period
of the study. During the follow-up period, patients will return to
the clinic every three months for evaluation of response. Patients
will remain on study until disease recurrence, disease progression,
death, or the last patient completes 12 months of follow-up (i.e.,
15 months after the first instillation), whichever occurs first. To
learn more about the UTOPIA trial, visit
clinicaltrials.gov/NCT06331299.
About UGN-103
UGN-103 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin being developed for the treatment of
LG-IR-NMIBC. Anticipated advantages of UGN-103 include a new
formulation of mitomycin that may considerably shorten the
manufacturing process and simplify the reconstitution procedure.
UroGen announced on September 16, 2024, that it received from the
United States Patent and Trademark Office (USPTO), a Notice of
Allowance covering, among other things, the use of UGN-103 in the
treatment of LG-IR-NMIBC. The U.S. patent, once issued, will have
an expiration date in December 2041. UGN-103 will utilize UroGen’s
proprietary RTGel technology, a sustained release, hydrogel-based
formulation designed to enable longer exposure of bladder tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical
means.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin, currently in Phase 3 development for
the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel
technology, a sustained release, hydrogel-based formulation,
UGN-102 is designed to enable longer exposure of bladder tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical
means. UGN-102 is delivered to patients using a standard urinary
catheter in an outpatient setting by a trained healthcare
professional. UroGen completed the NDA submission for UGN-102 in
August 2024, ahead of schedule, with a potential FDA decision as
early as the first quarter of 2025, if the NDA is accepted for
filing by the FDA and priority review is granted.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S. bladder cancer is the second most common urologic
cancer in men. LG-IR-NMIBC represents approximately 22,000 newly
diagnosed bladder cancer patients each year and an estimated 60,000
recurrences annually among patients diagnosed from previous years.
Bladder cancer primarily affects older populations with the median
age of diagnosis 73 years and an increased risk of comorbidities.
Guideline recommendations for the management of NMIBC include TURBT
as the standard of care. Up to 70 percent of NMIBC patients
experience at least one recurrence and LG-IR-NMIBC patients are
even more likely to recur and face repeated TURBT procedures.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat low-grade upper tract urothelial cancer, and our
investigational treatment UGN-102 (mitomycin) for intravesical
solution for patients with LG-IR-NMIBC are designed to ablate
tumors by non-surgical means. UroGen is headquartered in Princeton,
NJ with operations in Israel. Visit www.UroGen.com to learn more or
follow us on X (Twitter), @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: the
belief that UGN-103, if approved, will provide several advantages
related to production, cost, supply, product convenience, and
intellectual property protection; UroGen’s anticipated receipt of a
U.S. patent with an expiration date in December 2041; the potential
for UGN-102 to introduce a new non-surgical treatment option for
LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology
to improve therapeutic profiles of existing drugs and UroGen’s
sustained release technology making local delivery potentially more
effective as compared to other treatment options; the potential
timing for a decision from the FDA on the UGN-102 NDA submission
and the potential for priority review, as well as plans for UGN-103
to follow; the design and objectives of the UTOPIA study of
UGN-103; and the estimated annual U.S. patient population and
demographics for LG-IR-NMIBC. Words such as “aim,” “anticipate,”
“can,” “plan,” “potential,” “will,” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to: the anticipated advantages of UGN-103 have not yet been
demonstrated or achieved, as applicable, and it is possible one or
more of these anticipated advantages will not be realized;
preliminary results may not be indicative of results that may be
observed in the future; the timing and success of clinical trials
and potential safety and other complications thereof; unforeseen
delays that may impact the timing of progressing clinical trials,
reporting data and initiating product launches; the ability to
obtain regulatory approval within the timeframe expected, or at
all; even if an NDA for UGN-102 is accepted for filing by the FDA,
there is no guarantee that such NDA will be given priority review
or that such NDA will be sufficient to support approval of UGN-102
on the timeframe expected, or at all; the ability to maintain
regulatory approval; the ability to obtain and maintain adequate
intellectual property rights and adequately protect and enforce
such rights; complications associated with commercialization
activities; UroGen’s RTGel technology may not perform as expected;
and UroGen may not successfully develop and receive regulatory
approval of any other product that incorporates RTGel technology.
In light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of
UroGen’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2024, filed with the SEC on August 13, 2024 (which is available
at www.sec.gov), the events and circumstances discussed in such
forward-looking statements may not occur, and UroGen’s actual
results could differ materially and adversely from those
anticipated or implied thereby. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to UroGen as of the date of this release.
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version on businesswire.com: https://www.businesswire.com/news/home/20241002363009/en/
INVESTOR CONTACT: Vincent Perrone Senior Director,
Investor Relations vincent.perrone@UroGen.com 609-460-3588 ext.
1093
MEDIA CONTACT: Cindy Romano Director, Communications
cindy.romano@urogen.com 908-963-7827
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