Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis
25 Abril 2024 - 7:00AM
Business Wire
- Namilumab is a fully human monoclonal antibody that inhibits
granulocyte-macrophage colony-stimulating factor (GM-CSF), a
pro-inflammatory cytokine believed to play a key role in the
pathogenesis of sarcoidosis
- RESOLVE-Lung is a randomized, double-blind, placebo-controlled
Phase 2 study designed to be supportive of registration that
enrolled 107 pulmonary sarcoidosis patients whose disease is not
well-controlled despite currently available treatments
- Topline results are expected by the end of calendar year
2024
Roivant (Nasdaq: ROIV) and Kinevant Sciences, a clinical-stage
biopharmaceutical company developing new medicines for rare
inflammatory and autoimmune diseases, today announced the
successful completion of enrollment in its Phase 2 study evaluating
namilumab for the treatment of chronic pulmonary sarcoidosis
(RESOLVE-Lung). 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. Namilumab is
a potent anti-GM-CSF monoclonal antibody formulated to be
conveniently administered once-monthly as a subcutaneous injection
that has the potential to be the first disease-modifying therapy
for sarcoidosis. Potentially supportive of registration,
RESOLVE-Lung is a randomized, double-blind, placebo-controlled
Phase 2 study designed to enroll a minimum of 100 pulmonary
sarcoidosis patients whose disease is not well-controlled despite
currently available treatment options.
“People living with pulmonary sarcoidosis clearly need new
therapeutic options that can more safely and effectively control or
resolve their disease,” said Bill Gerhart, CEO of Kinevant.
“Completing enrollment for this study is an important milestone in
our journey to develop a new therapy for those living with
pulmonary sarcoidosis. I am grateful for the patients who
volunteered to participate in the study, as well as for the
extraordinary efforts of the Kinevant team, our industry partners,
clinical trial site staff, and patient advocacy groups, all of whom
came together to overcome the unique challenges of this disease to
successfully enroll this study. We are very hopeful about the
outcome, and we look forward to reporting topline results by the
end of the year.”
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.
Evidence from non-clinical studies indicate that GM-CSF is a key
cytokine driving granuloma formation and inflammation in
sarcoidosis, and that inhibiting GM-CSF can reduce granuloma
activity and the resulting inflammation, leading potentially to a
reduction in symptoms and resolution of the underlying disease.
Namilumab is a potent inhibitor of GM-CSF that has been observed to
be generally safe and well-tolerated in more than 350 participants
across multiple clinical trials. Thus, namilumab has the potential
to be the only well-tolerated and effective therapy for
sarcoidosis, as well as the first therapy approved specifically for
pulmonary sarcoidosis.
“Pulmonary sarcoidosis is a complex and challenging condition,
with limited treatment options, and many unacceptable side effects.
There is a need for new and better therapies to be developed,” said
Mary McGowan, CEO of the Foundation for Sarcoidosis Research. “We
are proud to have worked with Kinevant on the successful enrollment
of this clinical trial. We are grateful to the sarcoidosis patient
community who embraced this opportunity to lead us toward a
potential new therapy as well as a deeper understanding of
sarcoidosis.”
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 being conducted at multiple sites in the U.S.
and Europe. The study has enrolled 107 pulmonary sarcoidosis
patients considered not well-controlled despite available
therapeutic options. Patients in the study receive a once-monthly
subcutaneous injection of namilumab or placebo (following the
initial dosing period) for approximately six months. The goal of
the study is to assess the efficacy and safety of namilumab in
patients with pulmonary sarcoidosis during the 6-month blinded
treatment period. The primary endpoint is the difference in the
proportion of patients with a rescue event due to worsening of
their pulmonary sarcoidosis. Secondary endpoints include changes in
pulmonary function, patient reported outcomes, steroid use, safety,
and tolerability. All patients who complete the 26-week
double-blind treatment period are eligible to participate in a
28-week open-label extension treatment period on namilumab. More
information can be found at www.sarcoidosistrial.com.
About Namilumab
Namilumab is an investigational, fully human monoclonal antibody
formulated to be conveniently administered once a month as a
subcutaneous injection. Namilumab is a potent GM-CSF inhibitor that
has been well-tolerated so far in more than 350 participants across
multiple clinical trials. Evidence from non-clinical studies
indicate that GM-CSF promotes macrophage and dendritic cell
activity which contributes to granuloma formation. Inhibiting
GM-CSF can reduce the presence of granulomas and the resulting
inflammation, potentially leading to a reduction in symptoms and
resolution of the underlying disease.
About Kinevant Sciences
Kinevant Sciences, a subsidiary of Roivant, is a clinical-stage
biopharmaceutical company developing new medicines for rare
autoimmune and inflammatory diseases. The company takes a
patient-first approach to drug development, advancing candidates
with the potential to resolve the underlying disease and create
life-changing benefit for patients. Kinevant is initially focused
on the development of namilumab for the treatment of sarcoidosis, a
multi-organ systemic disease with a high unmet medical need. For
more information, visit www.kinevant.com or follow us on
LinkedIn.
About Roivant
Roivant is a commercial-stage biopharmaceutical company that
aims to improve the lives of patients by accelerating the
development and commercialization of medicines that matter. Today,
Roivant’s pipeline includes VTAMA®, a novel topical approved for
the treatment of psoriasis and in development for the treatment of
atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal
antibodies targeting the neonatal Fc receptor (“FcRn”) in
development across several IgG-mediated autoimmune indications;
brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development
for dermatomyositis, non-infectious uveitis, and other autoimmune
conditions, in addition to other clinical stage molecules. 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.
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