Tourmaline Bio Announces Expected Upcoming Key Milestones for the Clinical Development of TOUR006, a Long-Acting Subcutaneous Inhibitor of IL-6 with Best-in-Class Potential, in Thyroid Eye Disease (TED) and Atherosclerotic Cardiovascular Disease (ASCVD)
08 Enero 2024 - 6:00AM
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, announced today that:
- It is planning
to commence a pivotal Phase 3 trial for TOUR006 in TED in 2024.
This second pivotal trial will replace the previously planned TED
basket trial and does not impact Tourmaline’s expected cash runway
through 2026. Topline data from the ongoing Phase 2b spiriTED trial
are expected in the first half of 2025 and topline data from the
planned Phase 3 trial in TED are expected in 2026.
- Alignment has
been reached with the U.S. Food & Drug Administration (FDA) on
the ASCVD clinical development program, including a Phase 2 trial
evaluating the reduction of C-reactive protein (CRP), a validated
biomarker for inflammation, with quarterly dosing of TOUR006 in
patients with elevated cardiovascular risk. This trial is targeted
to commence in the first half of 2024, with topline data expected
in the first half of 2025. Pending success, the results from the
Phase 2 trial are expected to position Tourmaline to be ready in
2025 to commence a pivotal Phase 3 trial in cardiovascular
disease.
TOUR006 is a long-acting, fully-human, anti-IL-6
monoclonal antibody with best-in-class potential and differentiated
properties including a naturally long half-life, low
immunogenicity, and high binding affinity to IL-6. To date, TOUR006
has been studied in 448 participants, including patients with
autoimmune disorders, across six clinical trials.
“It is an exciting time in the IL-6 field, as
new insights and evidence emerge identifying a central role for
this validated drug target in TED and across many autoantibody and
inflammation-driven diseases,” said Sandeep Kulkarni, MD,
Co-Founder and Chief Executive Officer of Tourmaline. “We
believe TOUR006 offers the potential to fulfill the promise of this
IL-6 renaissance as we are aiming to achieve a best-in-class and
best-in-disease profile by addressing IL-6 mediated autoantibody
production and inflammation, while providing a patient-friendly
treatment through long-acting, low-volume subcutaneous
injections.”
Planned TED Development
Tourmaline’s pivotal Phase 3 trial is expected
to evaluate first-line use of TOUR006 in patients with TED. Subject
to FDA and other regulatory feedback, this trial is planned to be a
randomized, double-masked, placebo-controlled trial evaluating
TOUR006 administration on an eight-week dosing schedule. The
primary endpoint is expected to be proptosis response, or reduction
of abnormal eye protrusion, as measured at week 20 following three
subcutaneous (SC) administrations. Other efficacy endpoints are
anticipated to include additional measures such as clinical
activity score (CAS), diplopia and quality of life (QoL).
The ongoing spiriTED Phase 2b trial is the first
of two pivotal trials in TED evaluating TOUR006. This randomized,
double-masked, placebo-controlled trial is evaluating 20 mg and 50
mg doses versus placebo given by low-volume SC injections every
eight weeks. The study is enrolling a planned 81 participants with
moderate-to-severe TED who are in the active (inflammatory) phase
of disease. The primary endpoint is proptosis response as measured
at week 20 following three SC administrations. Other endpoints
include important additional efficacy measures such as CAS,
diplopia and QoL, as well as safety, pharmacokinetics,
pharmacodynamics, and immunogenicity.
Planned ASCVD Development
TOUR006 is also being developed for ASCVD using
quarterly, low-volume, SC administrations, in contrast to other
IL-6 pathway inhibitors that are in development that have more
frequent dosing regimens. The Phase 2 clinical trial of TOUR006 in
patients with elevated cardiovascular risk is expected to be a
randomized, double-blind, placebo-controlled trial with 120
patients across four different SC treatment arms: 50 mg quarterly,
25 mg quarterly, 15 mg monthly, and placebo. The primary endpoint
for this trial is change from baseline in high-sensitivity
C-reactive protein (hsCRP), a validated marker of IL-6 mediated
inflammation in ASCVD. The study will also evaluate other
biomarkers of IL-6 pathway activation as well as safety,
pharmacokinetics, and immunogenicity.
“Despite important advances in the management of
atherosclerotic cardiovascular disease, there continues to be a
large number of patients worldwide who remain at high risk for
major adverse cardiovascular events”, said Yung Chyung, MD,
Chief Medical Officer of Tourmaline. “We believe TOUR006
has the potential to address this significant unmet medical need by
targeting the IL-6 pathway as well as by offering a
patient-friendly, quarterly, low-volume subcutaneous dosing
regimen.”
About Tourmaline Bio, Inc.
Tourmaline 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.
About TOUR006
TOUR006 is a long-acting, fully-human, anti-IL-6
monoclonal antibody with best-in-class potential and differentiated
properties including a naturally long half-life, low
immunogenicity, and high binding affinity to IL-6. To date, TOUR006
has been studied in 448 participants, including patients with
autoimmune disorders, across six clinical trials. Tourmaline is
developing TOUR006 in TED and ASCVD as its first two indications,
with additional diseases under consideration.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995, including but
not limited to, express or implied statements regarding the
potential of, and expectations regarding, Tourmaline’s product
candidates, including TOUR006; the timing, initiation and success
of ongoing and new clinical trials for TOUR006 in TED and ASCVD;
expectations concerning decisions of regulatory bodies, including
the FDA, and the timing thereof; other drug candidates in
development; expectations regarding the sufficiency of Tourmaline’s
capital resources and cash runway; and other statements that are
not historical fact. All statements other than statements of
historical fact contained in this press release are forward-looking
statements. These forward-looking statements are made as of the
date they were first issued, and were based on the then-current
expectations, estimates, forecasts, and projections, as well as the
beliefs and assumptions of management. There can be no assurance
that future developments affecting Tourmaline will be those that
have been anticipated.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond Tourmaline’s control. Tourmaline’s actual results could
differ materially from those stated or implied in forward-looking
statements due to a number of factors, including but not limited to
(i) the uncertainties associated with Tourmaline’s platform
technologies, as well as risks associated with the clinical
development and regulatory approval of product candidates,
including potential delays in the commencement, enrollment and
completion of clinical trials; (ii) risks related to the
inability of Tourmaline to obtain sufficient additional capital to
continue to advance its product candidates and its preclinical
programs; (iii) uncertainties in obtaining successful clinical
results for product candidates of Tourmaline and unexpected costs
that may result therefrom; (iv) risks related to the failure
to realize any value from product candidates and preclinical
programs being developed and anticipated to be developed by
Tourmaline in light of inherent risks and difficulties involved in
successfully bringing product candidates to market; and
(v) the impacts of general macroeconomic and geopolitical
conditions, rising inflation, and uncertain credit and financial
markets on Tourmaline’s business, clinical trials and financial
position. These and other risks and uncertainties are more fully
described in periodic filings with the Securities and Exchange
Commission (the “SEC”), including the factors described in the
section titled “Risk Factors” in Tourmaline’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023. You should not
place undue reliance on these forward-looking statements, which are
made only as of the date hereof or as of the dates indicated in the
forward-looking statements. Except as may be required under
applicable law, Tourmaline expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
This press release does not purport to summarize all of the
conditions, risks and other attributes of an investment in
Tourmaline.
Investor Contact:
Lee M. SternMeru Advisorslstern@meruadvisors.com
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