Kinevant Sciences, a clinical-stage biopharmaceutical company
developing new medicines for rare inflammatory and autoimmune
diseases, today announced its Phase 2 study failed to show
treatment benefit in patients with chronic active pulmonary
sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated
the efficacy and safety of namilumab, an investigational
anti-GM-CSF monoclonal antibody administered once-monthly as a
subcutaneous injection, in participants with chronic active
pulmonary sarcoidosis.
Primary Endpoint Details: Namilumab failed to
meet the primary endpoint of proportion of subjects with a Rescue
Event during the double-blind period.
Secondary Endpoints Details: Secondary efficacy
endpoints, including change in percent predicted forced vital
capacity, corticosteroid tapering success, and change in the
patient reported King’s Sarcoidosis Questionnaire failed to show a
treatment benefit consistent with the primary endpoint.
Safety Details: The safety profile of namilumab
in RESOLVE-Lung remains similar to previous studies.
With these results, Kinevant will be discontinuing further
development of namilumab for the treatment of sarcoidosis. Kinevant
is committed to publishing the results of RESOLVE-Lung to inform
future sarcoidosis research.
“Although RESOLVE-Lung failed to show a treatment benefit for
namilumab, the significant amount of information produced by the
study will be tremendously helpful to those in the field who are
committed to improving the lives of sarcoidosis patients,” said
Bill Gerhart, CEO of Kinevant. “I would like to thank all the
patients who courageously volunteered to participate in the study,
as well as the Kinevant team, industry partners, principal
investigators, site staff, and patient advocacy groups who all
worked together to successfully conduct this important study for
sarcoidosis.”
“Risk-taking in clinical development is at the heart of our
industry, and core to Roivant’s mission of developing new medicines
for patients in need. It’s evident from our data that the
RESOLVE-Lung study was thoughtfully designed and gave us a clear
read on the potential benefits of namilumab in this patient
population,” said Matt Gline, CEO of Roivant. “Unfortunately
science is sometimes humbling, and we are proud to have made the
attempt, as well as of our successes in other programs this year.
We look forward to taking calculated risks on similar programs in
the future.”
About RESOLVE-Lung
The RESOLVE-Lung study is a Phase 2 randomized, double-blind,
placebo-controlled study of namilumab for the treatment of
pulmonary sarcoidosis at sites in the U.S. and Europe. The study
enrolled 107 patients with pulmonary sarcoidosis considered to have
chronic, active disease not well-controlled despite available
therapeutic options. Patients in the study received a once-monthly
subcutaneous injection of namilumab or placebo (following the
initial dosing period) for approximately six months. All patients
who complete the 26-week double-blind treatment period were
eligible to participate in a 28-week open-label extension treatment
period on namilumab.
The primary endpoint of this study was proportion of subjects
with a Rescue Event during the double-blind period. Rescue Event
was defined as clinically significant worsening of a subject’s
sarcoidosis requiring treatment, failure to adhere to the protocol
defined OCS taper, or premature discontinuation from the study
associated with lack of benefit during the double-blind treatment
period.
Study eligibility did not require subjects to be on high dose
corticosteroids. If subjects were on >5mg/day of oral
corticosteroid (OCS) at baseline, they were required to taper down
to 5mg/day 8-10 weeks after randomization. If patients were on an
immunosuppressive therapy (IST), they were required to stop the IST
at randomization. Notably, all subjects enrolled had evidence of
active pulmonary sarcoidosis disease, defined as a positive HRCT
scan, significant lung inflammation on PET, and moderate to severe
self-reported breathlessness.
About Sarcoidosis
Pulmonary sarcoidosis is a lung disease characterized by the
presence of granulomas (clumps of immune cells) of unknown etiology
that can cause breathlessness, fatigue, and pain. The resulting
inflammation, if not effectively treated, can result in lung tissue
scarring (fibrosis), lung dysfunction, and eventually lung failure.
Approximately 50% of diagnosed patients require chronic therapy to
treat symptoms and prevent progression. Oral steroids (e.g.,
prednisone) and off-label immunosuppressive therapies (e.g.,
methotrexate) are first- and second-line therapies respectively for
sarcoidosis; however, these therapeutic options are often not
effective or can be accompanied by serious side effects.
Approximately 200,000 people in the U.S. (and more than 1
million worldwide) are estimated to have sarcoidosis, an
immune-mediated inflammatory disease that can affect any organ in
the body, with about 90% of cases involving the lung.
About Namilumab
Granulocyte macrophage colony stimulating factor (GM-CSF) is a
pro-inflammatory cytokine over-expressed in several inflammatory
diseases, including sarcoidosis. GM-CSF mediated pro-inflammatory
signaling is thought to play a central role in recruitment of
macrophages and monocytes to the lung and to trigger a
granulomatous response, including the fusion of macrophages into
multinucleated giant cells. Namilumab is an anti-GM-CSF monoclonal
antibody formulated to be administered once-monthly as a
subcutaneous injection being investigated for the treatment of
pulmonary sarcoidosis.
About Roivant
Roivant is a biopharmaceutical company that aims to improve the
lives of patients by accelerating the development and
commercialization of medicines that matter. Roivant’s pipeline
includes IMVT-1402 and batoclimab, fully human monoclonal
antibodies targeting FcRn in development across several
IgG-mediated autoimmune indications; brepocitinib, a potent small
molecule inhibitor of TYK2 and JAK1 in development for the
treatment of dermatomyositis and non-infectious uveitis; and
mosliciguat, an inhaled sGC activator in development for pulmonary
hypertension associated with interstitial lung disease. We advance
our pipeline by creating nimble subsidiaries or “Vants” to develop
and commercialize our medicines and technologies. Beyond
therapeutics, Roivant also incubates discovery-stage companies and
health technology startups complementary to its biopharmaceutical
business. For more information, www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements.
Statements in this press release may include statements that are
not historical facts and are considered forward-looking within the
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the absence of these words does not mean that a statement is not
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Our forward-looking statements include, but are not limited to,
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hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our product
candidates, the availability and success of topline results from
our ongoing clinical trials and any commercial potential of our
product candidates following applicable regulatory approvals. In
addition, any statements that refer to projections, forecasts or
other characterizations of future events, results or circumstances,
including any underlying assumptions, are forward-looking
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Contacts:
InvestorsKeyur Parekhkeyur.parekh@roivant.com
MediaStephanie Leestephanie.lee@roivant.com
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