Urovant Sciences Announces Progression of URO-902 Phase 2a Trial Following Positive Recommendation from the Data & Safety Mon...
February 11 2021 - 8:00AM
Business Wire
Urovant Sciences (Nasdaq: UROV) announced today that the
independent Data and Safety Monitoring Board (DSMB) has recommended
the continuation of the phase 2a study of URO-902, a novel gene
therapy product, in patients with overactive bladder (OAB) and urge
urinary incontinence (UUI).
URO-902 has the potential to be the first gene therapy for
patients with OAB. Following the recommendation of the DSMB,
Urovant is proceeding with opening cohort 2 of the study with a
dose of 48 mg or placebo.
About the Phase 2a Study
This randomized, double blind, placebo-controlled study will
evaluate the efficacy, safety, and tolerability of a single
administration of URO-902, a novel gene therapy being developed for
patients with OAB who have failed oral pharmacologic therapy.
URO-902 is administered via direct intradetrusor injections into
the bladder wall under local anesthesia in patients who are
experiencing OAB symptoms and UUI.
The Phase 2a trial is expected to enroll approximately 80 female
patients in two cohorts: the first cohort received either a single
administration of 24 mg of URO-902 or matching placebo into the
bladder wall, and the second cohort will receive 48 mg of URO-902
or matching placebo into the bladder wall. Patients will be
followed for up to 48 weeks after initial administration. The
primary outcome measure is the change in the average daily number
of UUI episodes from baseline at week 12, as well as assessing the
safety and tolerability of this new potential therapy.
About URO-902
URO-902 has the potential to be the first gene therapy for
patients with OAB. This innovative treatment has the potential to
address an unmet need for patients who have failed oral
pharmacologic therapies and are concerned with potential urinary
retention or surgical interventions related to existing third-line
OAB treatments.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on
developing and commercializing innovative therapies for urologic
conditions. The Company’s lead product, GEMTESA® (vibegron), is an
oral, once-daily (75 mg) small molecule beta-3 agonist approved by
the U.S. FDA in December 2020 for the treatment of adult patients
with overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency and urinary frequency. GEMTESA is also being
evaluated for the treatment of OAB in men with benign prostatic
hyperplasia (OAB+BPH). The Company’s second product candidate,
URO-902, is a novel gene therapy being developed for patients with
OAB who have failed oral pharmacologic therapy. Urovant Sciences, a
subsidiary of Sumitomo Dainippon Pharma Co., Ltd., intends to
develop novel treatments for additional urologic diseases. Learn
more about us at www.urovant.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in
New York City and London. Sumitovant is a wholly owned subsidiary
of Sumitomo Dainippon Pharma. Sumitovant is the majority
shareholder of Myovant Sciences and Urovant Sciences, and wholly
owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant
Sciences. Sumitovant's promising pipeline is comprised of
early-through late-stage investigational medicines across a range
of disease areas targeting high unmet need. For further information
about Sumitovant, please visit https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and the
European Union. Sumitomo Dainippon Pharma is based on the 2005
merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more
than 6,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include all statements that are
not historical statements of fact and statements regarding the
Company’s intent, belief or expectations and can be identified by
words such as “anticipate,” “believe,” “can,” “continue,” “could,”
“estimate,” “expect,” “intend,” “likely,” “may,” “might,”
“objective,” “ongoing,” “plan,” “potential,” “predict,” “project,”
“should,” “strive,” “to be,” “will,” “would,” or the negative or
plural of these words or other similar expressions or variations,
although not all forward-looking statements contain these
identifying words. In this press release, forward-looking
statements include, but are not limited to, statements regarding
Urovant’s plans to advance the clinical development of URO-902 in
patients with OAB. Forward-looking statements are subject to risks
and uncertainties that could cause actual results to differ
materially and reported results should not be considered as an
indication of future performance. These risks and uncertainties
include, but are not limited to, risks associated with: the success
and cost of Urovant’s efforts to commercialize vibegron; Urovant’s
ability to realize the anticipated benefits of the co-promotion
agreement with Sunovion in the manner or timeline expected;
Urovant’s reliance on Sunovion for the co-promotion and
distribution of vibegron and Urovant’s ability to secure
alternative access to commercial infrastructure or strategic
collaborations for the commercialization or distribution of
products if it is unable to continue the relationship with
Sunovion; the success, cost, and timing of Urovant’s development
activities, including the timing of the initiation and completion
of clinical trials and the timing of expected regulatory filings;
the clinical utility and potential attributes and benefits of
vibegron, including reliance on collaboration partners and the
ability to procure additional sources of financing; our
intellectual property position, including the ability to identify
and in-license or acquire third-party patents and licenses, and
associated costs; and other risks and uncertainties listed in the
Company’s filings with the United States Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s most recently filed Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q filed with the SEC, as
such risk factors may be amended, supplemented or superseded from
time to time by other filings with the SEC. Given these risks and
uncertainties, you should not place undue reliance on any
forward-looking statements. These forward-looking statements are
based on information available to Urovant as of the date of this
press release and speak only as of the date of this release.
Urovant disclaims any obligation to update these forward-looking
statements, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210211005224/en/
Investor and Media Inquiries: Ryan Kubota
949.769.2706 ryan.kubota@urovant.com
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