Tourmaline Bio Presents Phase 2 TRANQUILITY Study Design at American Society of Preventive Cardiology (ASPC) Congress 2024
2024年8月3日 - 5:30AM
Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage
clinical biotechnology company developing transformative medicines
to dramatically improve the lives of patients with life-altering
immune and inflammatory diseases, today presented a poster at the
American Society of Preventive Cardiology (ASPC) Congress in Salt
Lake City, Utah, detailing the rationale and design of the
company’s TRANQUILITY Phase 2 study examining the potential of its
lead candidate, TOUR006, to reduce high-sensitivity C-reactive
protein (hs-CRP), a key biomarker of residual inflammatory
cardiovascular risk, in patients with chronic kidney disease (CKD)
and elevated hs-CRP.
Patients with CKD and elevated hs-CRP are at
heightened risk of atherosclerotic cardiovascular disease (ASCVD),
including heart attack, stroke, and peripheral artery disease,
despite current standard-of-care treatments. The IL-6 pathway has
been identified as a significant contributor to ASCVD risk,
particularly in CKD patients. TOUR006 has previously shown promise
in reducing hs-CRP levels in patients with inflammatory autoimmune
diseases.
“The TRANQUILITY study represents an important
step in understanding the potential of TOUR006 to address unmet
needs in patients with residual inflammatory cardiovascular risk,
despite lifestyle changes and available therapeutic interventions,”
said Emil deGoma, MD, Senior Vice President of Medical Research at
Tourmaline and former Medical Director of the Preventive
Cardiovascular Program at the University of Pennsylvania. “With a
robust clinical dataset from six previous trials involving 448
dosed study participants, comprised of healthy volunteers and
patients with diseases other than cardiovascular disorders, as well
as converging clinical evidence supporting the therapeutic
potential of IL-6 inhibition, we are confident in our approach and
the potential of TOUR006 and look forward to seeing the data from
this study.”
In the poster titled “Evaluating TOUR006
in Participants with Chronic Kidney Disease and Elevated hs-CRP:
Rationale and Design of the TRANQUILITY Phase 2 Study,”
Tourmaline provided an overview of the study design and rationale
behind investigating TOUR006 in patients with CKD and elevated
hs-CRP, highlighting:
- Objective: To
evaluate the hs-CRP-lowering effect, safety, tolerability, and
pharmacokinetics of TOUR006 in patients with CKD and elevated
hs-CRP.
- Design: A
randomized, double-blind, placebo-controlled, multicenter trial
involving approximately 120 patients with CKD stage 3 or 4 and
hs-CRP ≥2 and <15 mg/L.
- Methods:
Participants are stratified by CKD stage and randomized to receive
subcutaneous TOUR006 at doses of 50 mg quarterly, 25 mg quarterly,
15 mg monthly, or placebo. The primary pharmacodynamic endpoint is
the change in hs-CRP levels. Additional biomarkers being measured
include IL-6, lipoprotein(a), oxidized low-density lipoprotein
(LDL), and fibrinogen.
- Timeline: The
treatment and follow-up periods are 180 days and 185 days,
respectively, with the primary completion expected in May
2025.
The Phase 2 TRANQUILITY trial is expected to
inform the dosing regimen and design of any future Phase 3
cardiovascular studies in high-risk patients.
Additional meeting information can be found at
https://www.aspconline.org/2024congress
About the Phase 2 TRANQUILITY
TrialThe Phase 2 TRANQUILITY trial is a randomized,
double-blind, placebo-controlled study designed to evaluate the
safety, pharmacokinetics (PK), and pharmacodynamics (PD), including
CRP-lowering effect, of quarterly and monthly subcutaneous
administration of TOUR006 in patients with elevated
high-sensitivity C-reactive protein (hs-CRP) and chronic kidney
disease (CKD). The selection of dosing regimens being evaluated in
TRANQUILITY was informed by six previously completed Phase 1 and
Phase 2 trials of TOUR006 in healthy volunteers and patients with
rheumatoid arthritis, Crohn’s disease, or systemic lupus
erythematosus as well as PK/PD modeling. For more information on
the TRANQUILITY clinical trial, please visit clinicaltrials.gov
(NCT06362759).
About TOUR006 TOUR006 is a
long-acting, fully human, anti-IL-6 monoclonal antibody with
differentiated properties, including a naturally long half-life,
low immunogenicity, and high binding affinity to IL-6. TOUR006 has
been previously studied in 448 participants, including patients
with autoimmune disorders, across six completed clinical trials.
Tourmaline is developing TOUR006 in thyroid eye disease and
atherosclerotic cardiovascular disease as its first two
indications, with additional diseases under consideration.
About TourmalineTourmaline is a
late-stage clinical biotechnology company driven by its mission to
develop transformative medicines that dramatically improve the
lives of patients with life-altering immune and inflammatory
diseases. Tourmaline’s lead asset is TOUR006.
Cautionary Note Regarding
Forward-Looking Statements:Any statements contained in
this press release that do not describe historical facts may
constitute forward-looking statements as that term is defined in
the Private Securities Litigation Reform Act of 1995. These
statements may be identified by words and phrases such as
“believe,” “designed to,” “expect,” “may,” “plan,” “potential,”
“will” and similar expressions, and are based on Tourmaline’s
current beliefs and expectations. These forward-looking statements
include, but are not limited to, expectations regarding the
development and potential therapeutic benefits of TOUR006,
including the timing of initiation, progress and results of
Tourmaline’s current and future clinical trials for TOUR006, and
reporting of data therefrom, including the anticipation that
topline data from the Phase 2 TRANQUILITY trial will be available
in the first half of 2025, and the expectation that such data, if
successful, will position Tourmaline to be Phase 3-ready in 2025
for ASCVD and other cardiovascular diseases; and patient population
and market opportunities. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include
uncertainties inherent in the development of therapeutic product
candidates, such as the risk that any one or more of Tourmaline’s
current or future product candidates will not be successfully
developed or commercialized; the risk of delay or cessation of any
planned clinical trials of Tourmaline’s current or future product
candidates, including the Phase 2 TRANQUILITY trial; the risk that
prior results, such as signals of safety, activity or durability of
effect, observed from preclinical trials, will not be replicated or
will not continue in ongoing or future studies or clinical trials
involving Tourmaline’s current or future product candidates; the
risk that Tourmaline’s current or future product candidates or
procedures in connection with the administration thereof will not
have the safety or efficacy profile that Tourmaline anticipates;
risks regarding the accuracy of Tourmaline’s estimates of expenses,
capital requirements and needs for additional financing; changes in
expected or existing competition; changes in the regulatory
environment; the uncertainties and timing of the regulatory
approval process; unexpected litigation or other disputes; the
impacts of macroeconomic conditions Tourmaline’s business, clinical
trials and financial position; and other risks and uncertainties
that are described in Tourmaline’s Quarterly Report on Form 10-Q
filed with the U.S. Securities and Exchange Commission (“SEC”) on
May 13, 2024 and other filings that Tourmaline makes with the SEC
from time to time. Any forward-looking statements speak only as of
the date of this press release and are based on information
available to Tourmaline as of the date hereof, and Tourmaline
assumes no obligation to, and does not intend to, update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Media ContactScient PRSarah
MishekSMishek@ScientPR.com
Investor ContactMeru AdvisorsLee M.
Sternlstern@meruadvisors.com
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