Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage
biopharmaceutical company focused on the discovery, development,
and commercialization of novel treatments for patients suffering
from serious hematologic diseases, today announced the initiation
of a Phase 1 study of DISC-3405 (formerly MWTX-003) in healthy
volunteers. DISC-3405 is a monoclonal antibody designed to target
TMPRSS6 (Transmembrane Serine Protease 6, also known as
Matriptase-2) to increase hepcidin and decrease iron.
“The initiation of this trial marks the third program that Disc
has brought into the clinic and strengthens our position as leaders
in the field of hepcidin biology and iron homeostasis. We believe
DISC-3405 has potential across a broad range of diseases where
restricting iron may have therapeutic benefit, such as polycythemia
vera, iron overload conditions, and other diseases. We look forward
to pursuing those indications upon the completion of this trial,”
said John Quisel, J.D., Ph.D., President and Chief Executive
Officer of Disc. “This milestone comes at an exciting time for us,
as we plan to share data updates from ongoing clinical studies of
our other two programs, bitopertin and DISC-0974, later this
year.”
The study will be a randomized, double-blind,
placebo-controlled, single- and multiple-ascending dose Phase 1
trial in healthy volunteers and will evaluate safety, tolerability,
pharmacokinetics, and measures of pharmacodynamic activity,
including markers of iron homeostasis and erythropoiesis. The
single-ascending dose portion of the study is planned to enroll
four cohorts at increasing dose levels, starting with intravenous
administration with a plan to move to subcutaneous administration
later in the study. The multiple-ascending dose portion is planned
to enroll two cohorts, each receiving subcutaneous injections of
DISC-3405. Following completion of this study, Disc plans to
initiate a trial in polycythemia vera, for which DISC-3405 has
received Fast Track Designation.
About DISC-3405 (previously MWTX-003)
DISC-3405, formerly known as MWTX-003, is an investigational,
anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as
Matriptase-2) monoclonal antibody designed to increase hepcidin
production and suppress serum iron, that Disc in-licensed from
Mabwell Therapeutics in January 2023. Preclinical studies of
DISC-3405 have demonstrated an increase in hepcidin production and
suppression of serum iron levels in animal models of
beta-thalassemia and polycythemia vera. Disc plans to develop
DISC-3405 initially as a treatment for polycythemia vera as well as
other iron-overload conditions.
DISC-3405 is an investigational agent and is not approved for
use as a therapy in any jurisdiction worldwide.
About Disc Medicine
Disc Medicine (NASDAQ:IRON) is a clinical-stage
biopharmaceutical company committed to discovering, developing, and
commercializing novel treatments for patients who suffer from
serious hematologic diseases. We are building a portfolio of
innovative, potentially first-in-class therapeutic candidates that
aim to address a wide spectrum of hematologic diseases by targeting
fundamental biological pathways of red blood cell biology,
specifically heme biosynthesis and iron homeostasis. For more
information, please visit www.discmedicine.com.
Disc Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, express or implied statements
regarding Disc’s expectations with respect to its AURORA Phase 2
and BEACON Phase 2 clinical studies of bitopertin, and its Phase
1b/2 study of bitopertin in Diamond-Blackfan Anemia, its Phase 1b/2
clinical study of DISC-0974 in NDD-CKD patients with anemia, its
Phase 1 study of DISC-3405 and potential development of DISC-3405
as a treatment for polycythemia vera and other indications,
projected timelines for the initiation and completion of its
clinical trials, anticipated timing of release of data, and other
clinical activities; Disc’s business plans and objectives; and
Disc’s beliefs about operating expenses and that it will have
capital to fund Disc well into 2026. The use of words such as, but
not limited to, “believe,” “expect,” “estimate,” “project,”
“intend,” “future,” “potential,” “continue,” “may,” “might,”
“plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the
negative of these terms and other similar words or expressions that
are intended to identify forward-looking statements.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on Disc’s
current beliefs, expectations and assumptions regarding the future
of Disc’s business, future plans and strategies, clinical results
and other future conditions. New risks and uncertainties may emerge
from time to time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or
implied) are made about the accuracy of any such forward-looking
statements.
Disc may not actually achieve the plans, intentions or
expectations disclosed in these forward-looking statements, and
investors should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the
forward-looking statements as a result of a number of material
risks and uncertainties including but not limited to: the adequacy
of Disc’s capital to support its future operations and its ability
to successfully initiate and complete clinical trials; the nature,
strategy and focus of Disc; the difficulty in predicting the time
and cost of development of Disc’s product candidates; Disc’s plans
to research, develop and commercialize its current and future
product candidates; the timing of initiation of Disc’s planned
preclinical studies and clinical trials; the timing of the
availability of data from Disc’s clinical trials; Disc’s ability to
identify additional product candidates with significant commercial
potential and to expand its pipeline in hematological diseases; the
timing and anticipated results of Disc’s preclinical studies and
clinical trials and the risk that the results of Disc’s preclinical
studies and clinical trials may not be predictive of future results
in connection with future studies or clinical trials and may not
support further development and marketing approval; the other risks
and uncertainties described in the “Risk Factors” section of our
Annual Report on Form 10-K for the year ended December 31, 2022,
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2023 and June 30, 2023, and other documents filed by Disc from time
to time with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in Disc’s subsequent
filings with the SEC. Any forward-looking statement speaks only as
of the date on which it was made. None of Disc, nor its affiliates,
advisors or representatives, undertake any obligation to publicly
update or revise any forward-looking statement, whether as result
of new information, future events or otherwise, except as required
by law.
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Christina TartagliaStern Investor
Relationschristina.tartaglia@sternir.com
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