- VALOR is the largest interventional dermatomyositis study ever
conducted.
- Double-blind placebo-controlled study enrolled 241 subjects
randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg, and
placebo.
- Data are expected in the second half of 2025, with potential
dermatomyositis NDA submission to follow.
- Priovant also continues to rapidly progress development of
brepocitinib for non-infectious uveitis, with additional data from
the Phase 2 NEPTUNE study and initiation of an NDA-enabling Phase 3
program expected later this year.
DURHAM,
N.C., July 29, 2024 /PRNewswire/ -- Priovant
Therapeutics today announced completion of enrollment of the Phase
3 VALOR study evaluating brepocitinib in dermatomyositis. The study
enrolled 241 subjects across 90 sites in four continents, making it
the largest interventional dermatomyositis trial ever
conducted.
Dermatomyositis (DM) is a multi-organ idiopathic inflammatory
condition that affects approximately 40,000 adults in the United States. DM is characterized by
debilitating muscle weakness and skin lesions. Approximately half
of patients report falls and one third require mobility aids (e.g.,
canes, walkers, wheelchairs). Dermatomyositis rashes often affect
large portions of a patient's body including the scalp and can be
disfiguring and painful. In addition to skin and muscle
manifestations, DM can also impact other organ systems,
particularly through interstitial lung disease. The only approved
therapies for DM are steroidal products and intravenous
immunoglobulin (IVIg).
Brepocitinib is a dual selective inhibitor of TYK2 and JAK1
administered orally once daily. Through dual TYK2/JAK1 inhibition,
brepocitinib suppresses signaling of multiple pathogenic cytokines
that are understood to drive DM disease activity. Brepocitinib has
been dosed in over 1,400 subjects and generated positive results in
seven Phase 2 studies across multiple autoimmune diseases.
"Dermatomyositis is a highly morbid disease for which we have
limited treatment options available," said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi
and Scott C. Schuster Distinguished Chair in Dermatology, Director
of the Autoimmune Skin Disease Program and Connective Tissue
Disease Clinics at Brigham and Women's Hospital, and Program
Director for the Rheumatology-Dermatology Fellowship at
Harvard Medical School. "Brepocitinib
is a promising investigational therapy with the potential to
transform standard of care treatment for dermatomyositis if
approved. The rapid enrollment of the VALOR study reflects the
myositis medical community's commitment to this crucial goal. We
look forward to seeing the study's results next year and to ideally
having an excellent therapeutic option for our patients with this
debilitating disease."
VALOR is a double-blind placebo-controlled study with subjects
randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg, and
placebo. The primary endpoint in the VALOR study is the Total
Improvement Score (TIS) at 52 weeks. The TIS is a registrational
composite endpoint of six measures of DM disease activity.
Secondary endpoints include additional measurements of skin and
muscle disease, measurements of disease activity in other impacted
organ systems, steroid-sparing benefit, and patient-reported
quality of life outcomes. Data are anticipated in the second half
of calendar year 2025, with a potential NDA submission to
follow.
"The dermatomyositis patient community is optimistic that the
VALOR study will figure prominently in the history of our
collective efforts to improve the lives of people living with
dermatomyositis," said Lynn Wilson,
President of Myositis Support and Understanding (MSU). "Completed
enrollment of the VALOR study represents new medical possibilities
and much needed hope for so many patients and families."
Paula Eichenbrenner, Executive
Director of The Myositis Association (TMA), added "People living
with dermatomyositis experience an ongoing battle with the
debilitating consequences of their disease, and novel treatment
options are desperately needed. Successful enrollment of the VALOR
study brings excitement, and we are grateful to the dermatomyositis
community for embracing the opportunity to advance understanding of
this complex condition."
Priovant also continues to advance brepocitinib's development
for treatment of non-infectious uveitis (NIU), another highly
morbid autoimmune disease with significant unmet need. NIU is the
fourth leading cause of blindness among the working-age population
in the developed world. Primary endpoint data from the successful
Phase 2 NEPTUNE study were recently presented at the American
Society of Retina Specialists (ASRS) meeting, with additional
24-week results on vascular leakage and macular edema accepted as
oral presentations at the upcoming EURETINA Congress September 19-22 and American Academy of
Ophthalmology (AAO) annual meeting October
18-21. Priovant expects to share 52-week top-line results
from the NEPTUNE study and initiate an NDA-enabling Phase 3 program
by the end of 2024.
"Priovant continues to make progress towards our goal of
developing brepocitinib as a transformational therapy for highly
morbid autoimmune diseases where the need for novel efficacious
therapies is greatest," said Ben
Zimmer, Priovant CEO. "We deeply appreciate the time and
commitment of the patients, investigators, and site research staff
who enable this important work. We look forward to providing
further updates as we reach upcoming milestones in 2024 and
2025."
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to
developing novel therapies for autoimmune diseases with high
morbidity and few available treatment options. The company's lead
asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1.
Through dual TYK2/JAK1 inhibition, brepocitinib is able to
distinctively suppress key cytokines linked to
autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and
IL-23—with a single, targeted therapy. Brepocitinib is administered
as a once-daily oral therapy. It has been dosed in over 1,400
subjects and has generated positive data in seven Phase 2 studies.
Brepocitinib is currently being evaluated in a Phase 3 program for
dermatomyositis and is entering a Phase 3 program for
non-infectious uveitis.
Forward-Looking Statements
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about the clinical and therapeutic potential of our products and
product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of
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Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
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affected by a number of risks, uncertainties and assumptions.
Moreover, we operate in a very competitive and rapidly changing
environment in which new risks emerge from time to time. These
forward-looking statements are based upon the current expectations
and beliefs of our management as of the date of this press release
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
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Contact:
Daniel Herz-Roiphe
Priovant Therapeutics
daniel.herz-roiphe@priovanttx.com
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