SetPoint Medical Announces Positive Topline Results from Landmark RESET-RA Study Evaluating Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis
2024年7月10日 - 9:00PM
ビジネスワイヤ(英語)
The SetPoint System is the first neuroimmune
modulation device to demonstrate a clinical benefit in adults
living with moderate-to-severe rheumatoid arthritis
Study results will be presented at upcoming
medical meetings and will support FDA submission for approval of
SetPoint System as a novel treatment approach for rheumatoid
arthritis
SetPoint Medical, a clinical-stage healthcare company dedicated
to people living with chronic autoimmune diseases, today announced
positive topline results from the landmark RESET-RA clinical study.
RESET-RA is evaluating the SetPoint System as a potential
first-of-its-kind neuroimmune modulation treatment for adults
living with moderate-to-severe rheumatoid arthritis (RA) who are
incomplete responders or are intolerant to biologic or targeted
synthetic disease-modifying anti-rheumatic drugs (DMARDs).
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The study met its primary endpoint with a statistically
significant greater proportion of study participants achieving an
ACR20 response in the treatment group compared with the control
group at 12 weeks (p=0.0209). An ACR20 response is a composite
measure of the effectiveness for RA treatments set forth by the
American College of Rheumatology. Additionally, no safety concerns
have been observed during the first 12 weeks and long-term
follow-up, as available. Adverse event rates were low for both the
implant procedure and stimulation therapy, and overall treatment
was effective and well-tolerated.
“Despite multiple treatment options, including biologic
therapies and oral Janus kinase (JAK) inhibitors, there continue to
be challenges and unmet medical needs in managing rheumatoid
arthritis,” said David Chernoff, M.D., Chief Medical Officer of
SetPoint Medical. “A significant proportion of patients either do
not adequately respond to or are intolerant to currently approved
treatment options. Approved therapies can also have serious
immunosuppressive risks leading to safety concerns, poor patient
satisfaction, and low treatment adherence.”
More than 1.5 million Americans live with RA, a disease in which
the body’s immune system attacks its own tissue, often causing
pain, bone erosion, joint deformity, diminished function, and
long-term disability. There is no cure for RA, and current
therapies are associated with poor patient satisfaction and low
persistence rates. The majority of patients discontinue their
prescribed medication within two years, primarily due to lack or
loss of efficacy, and intolerance to side effects.1,2
The SetPoint System includes an implantable, rechargeable
neurostimulation device that electrically stimulates the vagus
nerve once daily to activate innate anti-inflammatory and
immune-restorative pathways, providing the potential to treat
autoimmune conditions like RA without the immunosuppressive risks
associated with pharmacological therapies. After placement during
an outpatient procedure, the SetPoint System is programmed to
automatically deliver therapy on a preset schedule to improve
compliance and persistence with therapy.
“We are thrilled with the results from the RESET-RA study as
they highlight the potential of the SetPoint System for providing
rheumatologists and their patients with a safe and effective
treatment alternative to current rheumatoid arthritis therapies,”
said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of
SetPoint Medical. “As next steps, we look forward to submitting the
data for presentation at upcoming rheumatology and neurosurgical
medical meetings, and completing our premarket approval submission
to the FDA.”
RESET-RA, a two-staged, multicenter, randomized,
sham-controlled, double-blind pivotal trial, enrolled a total of
242 patients across 41 sites in the U.S. Following the completion
of the primary endpoint at 12 weeks, the study continues to
evaluate the long-term safety and effectiveness of the device in an
open-label extension study. More information about RESET-RA is
available at ClinicalTrials.gov.
The SetPoint System has Breakthrough Device Designation from the
U.S. Food and Drug Administration (FDA) for patients with
moderate-to-severe RA with an incomplete response or intolerance to
one or more biological DMARDs or targeted synthetic DMARDs, such as
JAK inhibitors.
SetPoint's neuroimmune modulation platform was also granted
Breakthrough Device Designation and accepted into the Total Product
Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for
the treatment of relapsing-remitting multiple sclerosis (RRMS)
based on evidence demonstrating that the device has the potential
to reduce demyelination and promote remyelination in people living
with multiple sclerosis.
About SetPoint Medical
SetPoint Medical is a privately held clinical-stage healthcare
company dedicated to treating people living with chronic autoimmune
diseases. The company is developing a novel platform designed to
stimulate the vagus nerve to activate a neuroimmune pathway to
produce a systemic immune-restorative effect. SetPoint Medical’s
platform technology is designed to offer patients and providers a
treatment alternative for rheumatoid arthritis, multiple sclerosis,
inflammatory bowel disease and other chronic autoimmune conditions
with potentially less risk and cost than drug therapy. For more
information, visit www.setpointmedical.com.
1 Strand V, Miller P, Williams SA, et al. Discontinuation of
Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona
RA Registry. Rheumatol Ther 4, 489–502 (2017).
https://doi.org/10.1007/s40744-017-0078-y
2 Pope JE, Keystone E, Jamal S, et al. Persistence of
Tofacitinib in the Treatment of Rheumatoid Arthritis in Open-Label,
Long-Term Extension Studies up to 9.5 Years. ACR Open Rheumatol.
2019 Mar 28;1(2):73-82. doi: 10.1002/acr2.1010. PMID: 31777783;
PMCID: PMC6857988
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Emma Yang Health+Commerce media@setpointmedical.com