Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the
“Company”) today announced that two abstracts detailing next steps
in the development of the Company’s investigational antisense
oligonucleotide (ASO), AMX0114, for the potential treatment of
amyotrophic lateral sclerosis (ALS) and findings from a
pharmacokinetic and pharmacodynamic study of AMX0035 (sodium
phenylbutyrate [PB] and taurursodiol [TURSO]) in people with ALS
will be presented at the Muscular Dystrophy Association (MDA)
Clinical and Scientific Conference on March 3-6, 2024 in Orlando,
Florida. AMX0035 is marketed by Amylyx as RELYVRIO® and is approved
to treat ALS in adults in the U.S. and approved with conditions as
ALBRIOZA™ for the treatment of ALS in Canada.
Details of the poster presentations are as follows:
Title: Next Steps in Development for AMX0114: An
Antisense Oligonucleotide Targeting Calpain-2, a Critical Effector
of Axonal Degeneration The Company is advancing AMX0114, our
internally developed ASO targeting calpain-2, a critical effector
of axonal degeneration in ALS and other neurodegenerative diseases,
through investigational new drug enabling studies, with the goal of
entering the clinic in 2024. This poster shares details on
pre-clinical efficacy studies as well as introduces the design
approach for the first-in-human study, anticipated to begin later
this year. The Company is studying multiple cellular pathways
implicated in disease pathogenesis as we believe that it is going
to take a combination approach to find a cure for ALS. Date and
Time: March 4, 2024, from 6:00PM – 8:00PM EST
Title: Findings From a Pharmacokinetic and
Pharmacodynamic Study of Sodium Phenylbutyrate and Taurursodiol in
Participants With Amyotrophic Lateral Sclerosis This poster
provides results from a Phase 2a, open-label, sequential period
study of AMX0035 pharmacokinetics in participants with ALS and
includes safety data in addition to pharmacokinetics of AMX0035 and
its major metabolites. No new safety signals were identified during
this study. Date and Time: March 4, 2024, from 6:00PM –
8:00PM EST
For conference information, visit:
https://www.mdaconference.org/
Additional information, including copies of the poster
presentations, will be made available on the “Publications” tab of
the Amylyx website, following the conclusion of the poster
presentations.
About RELYVRIO®/ ALBRIOZA™ / ALBRIOZA® / AMX0035
RELYVRIO®, an oral, fixed-dose combination of sodium
phenylbutyrate and taurursodiol (known as ursodoxicoltaurine
outside of the U.S.), is approved to treat amyotrophic lateral
sclerosis (ALS) in adults in the U.S. and approved with conditions
as ALBRIOZA™ for the treatment of ALS in Canada. AMX0035 is being
studied for the potential treatment of other neurodegenerative
diseases, and Amylyx is exploring its treatment in other
populations and regions. The formulation of RELYVRIO, ALBRIOZA, and
AMX0035 are identical.
RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety
Information for United States
WARNINGS AND PRECAUTIONS
Risk in Patients with Enterohepatic Circulation Disorders,
Pancreatic Disorders, or Intestinal Disorders
RELYVRIO contains taurursodiol, which is a bile acid. In
patients with disorders that interfere with bile acid circulation,
there may be an increased risk for worsening diarrhea, and patients
should be monitored appropriately for this adverse reaction.
Pancreatic insufficiency, intestinal malabsorption, or intestinal
diseases that may alter the concentration of bile acids may also
lead to decreased absorption of either of the components of
RELYVRIO. Because different enterohepatic circulation, pancreatic,
and intestinal disorders have varying degrees of severity, consider
consulting with a specialist. Patients with disorders of
enterohepatic circulation (e.g., biliary infection, active
cholecystitis), severe pancreatic disorders (e.g., pancreatitis),
and intestinal disorders that may alter concentrations of bile
acids (e.g., ileal resection, regional ileitis) were excluded from
the study; therefore, there is no clinical experience in these
conditions.
Use in Patients Sensitive to High Sodium Intake
RELYVRIO has a high salt content. Each initial daily dosage of 1
packet contains 464 mg of sodium; each maintenance dosage of 2
packets daily contains 928 mg of sodium. In patients sensitive to
salt intake (e.g., those with heart failure, hypertension, or renal
impairment), consider the amount of daily sodium intake in each
dose of RELYVRIO and monitor appropriately.
ADVERSE REACTIONS
The most common adverse reactions (at least 15% and at least 5%
greater than placebo) with RELYVRIO were diarrhea, abdominal pain,
nausea, and upper respiratory tract infection.
Gastrointestinal-related adverse reactions occurred throughout the
study but were more frequent during the first 3 weeks of
treatment.
Please click here for RELYVRIO Full U.S.
Prescribing Information.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is committed to supporting and
creating more moments for the neurodegenerative community through
the discovery and development of innovative new treatments. Amylyx
is headquartered in Cambridge, Massachusetts and has operations in
Canada, EMEA, and Japan. For more information, visit amylyx.com and
follow us on LinkedIn and X, formerly known as Twitter. For
investors, please visit investors.amylyx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, the potential of
AMX0114 as a treatment for ALS and the Company’s plans to develop
AMX0114, the potential of AMX0035 as a treatment for ALS and the
Company’s plans to explore the use of AMX0035 for other
neurodegenerative diseases including PSP, the timelines for the
ORION study in PSP, and expectations regarding our longer-term
strategy. Any forward-looking statements in this press release are
based on management’s current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include: Amylyx’ ability to fund operations, the
success, cost, and timing of Amylyx’ program development
activities, Amylyx’ ability to execute on its commercial and
regulatory strategy, regulatory developments, expectations
regarding the timing and outcome of EMA’s review of AMX0035 for the
treatment of ALS, Amylyx’ reliance on third parties, including to
conduct clinical trials and manufacture products, and the effect of
global economic uncertainty and financial market volatility caused
by economic effects of rising inflation and interest rates, the
COVID-19 pandemic, geopolitical instability, changes in
international trade relationships and military conflicts, as well
as the risks and uncertainties set forth in Amylyx’ United States
Securities and Exchange Commission (SEC) filings, including Amylyx’
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023, and subsequent filings with the SEC. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Subject to any obligations under
applicable law, Amylyx undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240215456558/en/
Media Amylyx Media Team +1 (857) 799-7274
amylyxmediateam@amylyx.com Investors Lindsey Allen +1 (857)
320-6244 Investors@amylyx.com
Amylyx Pharmaceuticals (NASDAQ:AMLX)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Amylyx Pharmaceuticals (NASDAQ:AMLX)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024