Study showed clinically meaningful impact on
common symptoms of overactive bladder (OAB) compared to placebo
from baseline to week 12
Urovant Sciences, a wholly-owned subsidiary of Sumitovant
Biopharma Ltd., today announced positive topline results from its
Phase 2a, double-blind, placebo-controlled exploratory study of
URO-902, an investigational, novel, locally injected gene therapy
product (plasmid human cDNA encoding maxi-K channel), in patients
with overactive bladder (OAB), who were not well managed by oral
therapies.
“URO-902 showed a clinically meaningful and statistically
significant effect on a number of relevant outcome measures in OAB
including number of micturitions, urgency episodes, and quality of
life indicators compared to placebo, 12 weeks post-administration,”
said Cornelia Haag-Molkenteller, MD, PhD, executive vice president
and chief medical officer of Urovant Sciences. “URO-902 was well
tolerated, compared to placebo. The most common adverse event was
urinary tract infection, in both treatment groups.” We are
encouraged by these positive results and pending the completion of
the study in Fall 2022 and we look forward to discussing next steps
for the URO-902 clinical development plan.”
The Phase 2a study included 80 female patients and was designed
to evaluate the efficacy, safety, and tolerability of a single,
physician administered dose of URO-902 of 24 milligrams (mg) and 48
mg, compared with placebo with a primary timepoint at week 12
post-administration. Patients were followed for up to 48 weeks
post-administration. URO-902 has the potential to be the first gene
therapy for patients with OAB.
“These promising results suggest that URO-902 could potentially
offer a new treatment option for patients with overactive bladder
who have been inadequately managed by oral pharmacologic therapy,”
said Kenneth Peters, MD, principal investigator, and chief of the
department of urology at Beaumont Hospital, Royal Oak; Medical
director of the Beaumont Women’s Urology and Pelvic Health Center
and professor and chair of urology of the Oakland University
William Beaumont School of Medicine in Rochester, Michigan.
The company plans to present the topline results of the study at
the American Urological Association annual meeting being held May
13-16, 2022 in New Orleans, LA.
About the Phase 2a Study
The study was a randomized, double blind, placebo-controlled
trial to evaluate the efficacy, safety, and tolerability of a
single physician administered dose of URO-902, a novel gene therapy
being developed for patients with OAB who have not been adequately
managed with oral or transdermal pharmacologic therapy for OAB.
URO-902 is administered via direct intradetrusor injections into
the bladder wall under local anesthesia in patients who are
experiencing OAB symptoms and urge urinary incontinence (UUI).
The Phase 2a trial enrolled 80 female patients in two cohorts:
the first cohort received either a single administration of 24 mg
of URO-902 or matching placebo, and the second cohort received 48
mg of URO-902 or matching placebo into the bladder wall. Multiple
outcome measures were explored, including the effect on the number
of micturitions, urgency episodes, and quality of life indicators
compared to placebo, 12 weeks post-administration, as well as an
assessment of the safety and tolerability of this potential new
therapy. Patients were followed for up to 48 weeks after initial
administration.
About URO-902
URO-902 has the potential to be the first gene therapy for
patients with OAB. If approved, this innovative treatment may
address an unmet need for patients who have not been adequately
managed by oral or transdermal pharmacologic OAB therapies and are
concerned with potential urinary retention with other minimally
invasive therapies 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 areas of
unmet need, with a dedicated focus in Urology. The Company’s lead
product, GEMTSA®(vibegron), is an oral, once-daily (75 mg) small
molecule beta-3 agonist for the treatment of adult patients with
overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency, and urinary frequency. GEMTESA was approved
by the U.S. FDA in December 2020 and launched in the U.S. in April
2021. GEMTESA is also being evaluated for the treatment of OAB in
men with benign prostatic hyperplasia. 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 wholly owned subsidiary of Sumitovant Biopharma
Ltd., intends to bring innovation to patients in need in urology
and other areas of unmet need. Learn more about us at
www.urovant.com or follow us on Twitter or LinkedIn.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging
data-driven insights to rapidly accelerate development of new
potential therapies for unmet patient conditions. Through our
unique portfolio of wholly-owned “Vant” subsidiaries—Urovant,
Enzyvant, Spirovant, Altavant—and use of embedded computational
technology platforms to generate business and scientific insights,
Sumitovant has supported the development of FDA-approved products
and advanced a promising pipeline of early-through late-stage
investigational assets for other serious conditions. Sumitovant, a
wholly-owned subsidiary of Sumitomo Dainippon Pharma, is also the
majority-shareholder of Myovant (NYSE: MYOV). For more information,
please visit our website at www.sumitovant.com or follow us on
Twitter and LinkedIn.
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 other
Asian countries. 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 7,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
About GEMTESA®
GEMTESA is a prescription medicine for adults used to treat the
following symptoms due to a condition called overactive
bladder:
- urge urinary incontinence: a strong need to urinate with
leaking or wetting accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if GEMTESA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or any of
the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your medical
conditions, including if you have liver problems; have kidney
problems; have trouble emptying your bladder or you have a weak
urine stream; take medicines that contain digoxin; are pregnant or
plan to become pregnant (it is not known if GEMTESA will harm your
unborn baby; talk to your doctor if you are pregnant or plan to
become pregnant); are breastfeeding or plan to breastfeed (it is
not known if GEMTESA passes into your breast milk; talk to your
doctor about the best way to feed your baby if you take
GEMTESA).
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Know the medicines you take. Keep a list of them to
show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability
to empty your bladder (urinary retention). GEMTESA may increase
your chances of not being able to empty your bladder, especially if
you have bladder outlet obstruction or take other medicines for
treatment of overactive bladder. Tell your doctor right away if you
are unable to empty your bladder.
The most common side effects of GEMTESA include headache,
urinary tract infection, nasal congestion, sore throat or runny
nose, diarrhea, nausea and upper respiratory tract infection. These
are not all the possible side effects of GEMTESA. For more
information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please click here for full Product Information for GEMTESA.
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version on businesswire.com: https://www.businesswire.com/news/home/20220307005756/en/
Urovant Sciences Alana Darden Powell Vice President,
Corporate Communications 949-436-3116
alana.darden@Urovant.com media@urovant.com Sumitovant
Biopharma Maya Frutiger Head of Corporate
Communications media@sumitovant.com
Urovant Sciences (NASDAQ:UROV)
過去 株価チャート
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Urovant Sciences (NASDAQ:UROV)
過去 株価チャート
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