Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the United States
May 31 2022 - 8:30AM
Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative
biopharmaceutical company focused on efficiently acquiring,
developing and commercializing or monetizing promising therapeutic
products and product candidates, today announced that its
subsidiary company, UR-1 Therapeutics, Inc. (“UR-1”), dosed the
first patient in a Phase 1 clinical trial evaluating Dotinurad for
the treatment of gout in the United States.
The principal objective of this Phase 1 clinical
trial is to study the safety, tolerability, pharmacokinetics and
pharmacodynamics of multiple doses of Dotinurad in Western
subjects. Subjects will be randomized into a placebo-controlled
crossover clinical trial design to evaluate a wide range of
Dotinurad doses.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman
and Chief Executive Officer, said, “The successful dosing of the
first patient in this Phase 1 clinical trial to evaluate Dotinurad
for the treatment of gout is an important milestone for UR-1 and
Fortress and we expect to announce topline data in the second half
of 2022. Our goal is to leverage the exceptional clinical efficacy
and safety profile of Dotinurad to create a superior treatment
option for the nearly 10 million patients suffering from gout in
the U.S. If approved in the U.S., Dotinurad has the potential to be
the most potent oral therapy for lowering serum uric acid levels
with an excellent safety and efficacy profile vis-à-vis earlier
generations of URAT inhibitors. There is also further potential to
evaluate this product candidate in other diseases, including
chronic kidney disease and heart failure.”
About DotinuradIn May 2021,
Fortress announced an exclusive license agreement between its
subsidiary, UR-1, and Fuji Yakuhin Co. Ltd. to develop Dotinurad in
North America and Europe. Dotinurad is a potential best-in-class
urate transporter (URAT1) inhibitor for gout and possibly other
hyperuricemic indications including chronic kidney disease and
heart failure. It can lower blood uric acid levels by selectively
inhibiting URAT1 and uric acid reabsorption in the kidneys.
Dotinurad (URECE® tablet) was approved in Japan in 2020 as a
once-daily oral therapy for gout and hyperuricemia. Dotinurad was
efficacious and well-tolerated in more than 500 Japanese patients
treated for up to 58 weeks in Phase 3 clinical trials. Its efficacy
was non-inferior to Febuxostat, which has a black box warning for
increased risk of cardiovascular death, and was well-tolerated with
low safety risk and drug interaction.1,2,3 Over 1,000 Japanese
patients have been treated safely with Dotinurad.
About GoutGout is a serious,
progressive and debilitating inflammatory arthritis caused by
deposits of uric acid crystal in and around the connective tissue
of joints, tendons and the kidneys. There are nearly 20 million
diagnosed patients with gout in the US, Europe and Canada as of
2021,4,5,6 and it is estimated that two to three million U.S.
patients are unsatisfied with their urate-lowering therapy and
their serum uric acid levels remain inadequately controlled.7,8
About UR-1 TherapeuticsUR-1
Therapeutics, Inc. (“UR-1”) is a clinical-stage biopharmaceutical
company that focuses on the development and commercialization of
pharmaceutical products to treat gout and chronic kidney disease.
UR-1 acquired the rights to develop and commercialize Dotinurad, a
potentially best-in-class URAT1 inhibitor, in the United States,
United Kingdom, European Union and Canada from Fuji Yakuhin.
Dotinurad has been approved to treat gout and hyperuricemia in
Japan and is currently in a Phase 1 clinical trial in the United
States. UR-1 was founded by Fortress Biotech, Inc. (NASDAQ:
FBIO).
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical
company focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug
candidates. The company has nine marketed prescription
pharmaceutical products and over 30 programs in development at
Fortress, at its majority-owned and majority-controlled partners
and subsidiaries and at partners and subsidiaries it founded and in
which it holds significant minority ownership positions. Such
product candidates span six large-market areas, including oncology,
rare diseases and gene therapy, which allow it to create value for
shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug
development. The Fortress model is driven by a world-class business
development team that is focused on leveraging its significant
biopharmaceutical industry expertise to further expand the
company’s portfolio of product opportunities. Fortress has
established partnerships with some of the world’s leading academic
research institutions and biopharmaceutical companies to maximize
each opportunity to its full potential, including AstraZeneca plc,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude
Children’s Research Hospital, Nationwide Children’s Hospital and
Sentynl Therapeutics, Inc. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “we”, “us” and
“our” may refer to Fortress individually or together with one or
more partner companies, as dictated by context. Such statements
include, but are not limited to, any statements relating to our
growth strategy and product development programs, ability to
generate shareholder value, ability of our products to receive
necessary approvals, including FDA, ability of our products and
therapies to help patients and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; risks relating to the
timing of starting and completing clinical trials, including
disruptions that may result from hostilities in Europe; our
dependence on third-party suppliers; risks relating to the COVID-19
outbreak and its potential impact on our employees’ and
consultants’ ability to complete work in a timely manner and on our
ability to obtain additional financing on favorable terms or at
all; our ability to attract, integrate and retain key personnel;
the early stage of products under development; our need for
substantial additional funds; government regulation; patent and
intellectual property matters; competition; as well as other risks
described in our SEC filings. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as may
be required by law, and we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contacts:Jaclyn Jaffe and Bill
BegienFortress Biotech, Inc.(781)
652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
References
- Clin Exp Nephrol . 2020
Mar;24(Suppl 1):71-79.
- Clin Exp Nephrol. 2020 Mar;24(Suppl
1):62-70.
- Clin Exp Nephrol. 2020 Mar;24(Suppl
1):80-91.
- Rheumatology (Oxford) . 2019 Dec
1;58(12):2177-2180.
- Semin Arthritis Rheum. 2017 Feb;
46(4): 451–456.
- GlobalData. Gouty Arthritis (Gout):
Competitive Landscape in 2021.
- Arthritis Rheumatol. 2019 Jun;
71(6): 991–999.
- J Rheumatol . 2016
Oct;43(10):1897-1903.
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