Artelo Biosciences Completes Positive Pre-IND Meeting with FDA for ART26.12
2023年9月7日 - 9:00PM
Artelo Biosciences, Inc. (Nasdaq:
ARTL), a clinical-stage pharmaceutical company
focused on modulating lipid-signaling pathways to develop
treatments for people living with cancer, pain, and neurological
conditions, today announced it has completed a pre-IND
(Investigational New Drug) meeting with the U.S. Food and Drug
Administration (FDA) regarding the manufacturing, preclinical and
clinical development plan for ART26.12. Based on the FDA’s
feedback, the Company also announced that it plans to file an IND
application for the use of ART26.12 in neuropathic pain in the
first half of 2024.
ART26.12 is a potential first-in-class orally administered Fatty
Acid Binding Protein 5 (FABP5) inhibitor drug, initially under
development for the prevention of chemotherapy-induced peripheral
neuropathy, a debilitating and often treatment-altering side effect
of cancer therapy. The FDA reviewed the IND-enabling preclinical
data, manufacturing plans, and clinical study protocol synopses,
provided guidance, and answered Artelo's questions on the
development plan.
“We greatly value the FDA's guidance as we complete our
remaining IND-enabling studies," said Dr. Andrew Yates, Chief
Scientific Officer at Artelo Biosciences. "The guidance we received
was positive and validating as we prepare to advance ART26.12 into
the clinic.”
Gregory Gorgas, CEO of Artelo Biosciences, further noted, “We
look forward to filing an IND application in order to obtain
clearance for the first-in-human ART26.12 Phase 1 clinical trial.
Importantly, based on our preclinical studies, we believe ART26.12
holds the promise to address a variety of painful neuropathies,
whether they are caused by chemotherapy or are disease related such
as diabetic neuropathy.”
According to Persistence Market Research, the global neuropathic
pain market was approximately $7.6 billion in 2022 and is expected
to exceed $14 billion by the end of 2033.
About ART26.12Fatty Acid Binding Proteins
(FABPs) are a family of intracellular proteins that chaperone
lipids including endocannabinoids and fatty acids. Various
inhibitors of FABPs may be particularly useful for the treatment of
specific cancers, neuropathic and nociceptive pain, and anxiety
disorders. ART26.12, Artelo’s lead FABP inhibitor compound, is a
selective inhibitor of FABP5. While developing our lead molecule
for chemotherapy-induced peripheral neuropathy, additional
compounds from our extensive library of potent and selective
inhibitors of FABPs have been identified and selected for
advancement towards regulatory-enabling studies in cancer and other
areas of high-unmet need where inhibition of FABPs show significant
promise.
About Painful NeuropathiesPeripheral neuropathy
refers to a condition in which there is damage to the peripheral
nerves. These nerves are responsible for transmitting signals
between the central nervous system and the rest of the
body. Chemotherapy-induced peripheral neuropathy (CIPN) is a
common and often painfully debilitating complication of cancer
therapies, sometimes resulting in reduction or cessation of
treatment. No currently approved treatment exists for
CIPN. Diabetic neuropathy refers to a type of nerve
damage that occurs as a complication of diabetes. It is caused by
long-term high blood sugar levels, which can lead to damage of the
blood vessels and nerves throughout the body. The
prevalence of diabetic neuropathy is significant due to the
increasing number of people with diabetes worldwide.
About Artelo BiosciencesArtelo Biosciences,
Inc. is a clinical stage pharmaceutical company dedicated to
the development and commercialization of proprietary therapeutics
that modulate lipid-signaling pathways including the
endocannabinoid system. Artelo is advancing a portfolio of broadly
applicable product candidates designed to address significant unmet
needs in multiple diseases and conditions, including anorexia,
cancer, anxiety, pain, neuropathy, and inflammation. Led by proven
biopharmaceutical executives collaborating with highly respected
researchers and technology experts, the company applies leading
edge scientific, regulatory, and commercial discipline to develop
high-impact therapies. More information is available
at www.artelobio.com and Twitter: @ArteloBio.
Forward Looking StatementsThis press release
contains certain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 and Private Securities Litigation
Reform Act, as amended, including those relating to the Company’s
planned IND application, product development, clinical and
regulatory timelines, market opportunity, competitive position,
possible or assumed future results of operations, business
strategies, potential growth opportunities and other statement that
are predictive in nature. These forward-looking statements are
based on current expectations, estimates, forecasts and projections
about the industry and markets in which we operate and management’s
current beliefs and assumptions. These statements may be identified
by the use of forward-looking expressions, including, but not
limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,”
“estimate,” “potential,” “predict,” “project,” “should,” “would”
and similar expressions and the negatives of those terms. These
statements relate to future events or our financial performance and
involve known and unknown risks, uncertainties, and other factors
which may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Such factors include those set forth in the Company’s
filings with the Securities and Exchange Commission, including our
ability to raise additional capital in the future. Prospective
investors are cautioned not to place undue reliance on such
forward-looking statements, which speak only as of the date of this
press release. The Company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events or otherwise, except to the extent
required by applicable securities laws.
Investor Relations Contact:Crescendo
Communications, LLCTel:
212-671-1020Email: ARTL@crescendo-ir.com
Artelo Biosciences (NASDAQ:ARTL)
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Artelo Biosciences (NASDAQ:ARTL)
過去 株価チャート
から 5 2023 まで 5 2024