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 that the United
States Patent and Trademark Office (USPTO) has issued patent No.
11,813,257 for methods of treating erythropoietic protoporphyrias
(EPPs) with glycine transport inhibitors.
“We are pleased to have been issued this patent that further
secures IP protection for bitopertin for the treatment of
erythropoietic protoporphyria as we work to deliver a potentially
transformative therapy to patients,” said John Quisel, J.D., Ph.D.,
President and Chief Executive Officer of Disc. “This patent further
highlights the innovative approach we are taking to treat EPP, as
demonstrated by the data we shared in June, which we will update at
ASH in December.”
This patent covers uses of bitopertin, a glycine transport
inhibitor, in treating erythropoietic protoporphyria (EPP) or
X-linked protoporphyria (XLP) with an anticipated expiration in
2041, before any available term extensions or adjustments. Disc
intends to continue to prosecute additional patent applications to
support use of bitopertin in treating hematologic disorders.
About BitopertinBitopertin is an
investigational, clinical-stage, orally-administered inhibitor of
glycine transporter 1 (GlyT1) that is designed to modulate heme
biosynthesis. GlyT1 is a membrane transporter expressed on
developing red blood cells and is required to supply sufficient
glycine for heme biosynthesis and support erythropoiesis. Disc is
planning to develop bitopertin as a potential treatment for a range
of hematologic diseases including erythropoietic porphyrias, where
it has potential to be the first disease-modifying therapy. There
are currently two ongoing Phase 2 clinical trials of bitopertin in
patients with erythropoietic porphyria, including an open-label
trial called BEACON and a randomized, double-blind
placebo-controlled trial called AURORA.
Bitopertin is an investigational agent and is not approved for
use as a therapy in any jurisdiction worldwide. Disc obtained
global rights to bitopertin under a license agreement from Roche in
May 2021.
About Erythropoietic Protoporphyria (EPP) and X-linked
Protoporphyria (XLP)Erythropoietic protoporphyria (EPP)
and X-linked Protoporphyria (XLP) are rare, debilitating and
potentially life-threatening diseases caused by mutations that
affect heme biosynthesis, resulting in the accumulation of a toxic,
photoactive intermediate called protoporphyrin IX (PPIX). This
causes severe reactions when patients are exposed to sunlight,
characterized by excruciating pain, edema, burning sensations and
potential blistering and disfigurement. PPIX also accumulates in
the hepatobiliary system and can result in complications including
gallstones, cholestasis, and liver damage in 20-30% of patients and
in extreme cases liver failure. Current standard of care involves
extreme measures to avoid sunlight, including restricting outdoor
activities to nighttime, use of protective clothing and opaque
shields, and pain management. This has a significant impact on the
psychosocial development, quality of life, and daily activities of
patients, particularly in young children and families. There is
currently no cure for EPP and only one FDA-approved therapy, a
surgically implanted synthetic hormone designed to stimulate
melanin production called Scenesse® (afamelanotide).
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 patent portfolio
for bitopertin; its AURORA Phase 2 and BEACON Phase 2 clinical
studies of bitopertin and the results thereof; projected timelines
for the initiation and completion of its clinical trials,
anticipated timing of release of data, and other clinical
activities; and Disc’s business plans and objectives. 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 patent portfolio for bitopertin for the treatment of EPP;
Disc’s ability to further enhance patent protection for bitopertin
in treating disorders of heme biosynthesis; the nature, strategy
and focus of Disc; Disc’s plans to research, develop and
commercialize its current and future product candidates; that the
issuance of a patent for Disc’s methods of treating EPPs may not
necessarily be predictive of an innovative approach to treat EPP;
the timing of the availability of data from Disc’s clinical trials;
the timing and anticipated results of Disc’s preclinical studies
and clinical trials and the risk that the results of Disc’s
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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