Neumora Therapeutics Announces NMRA-266 IND Clearance and Initiation of Phase 1 Clinical Study
27 Novembre 2023 - 1:00PM
Neumora Therapeutics, Inc. (Neumora), a
clinical-stage biopharmaceutical company redefining neuroscience
drug development, today announced the initiation of a Phase 1
single ascending dose / multiple ascending dose study evaluating
NMRA-266 in healthy adult participants. NMRA-266 is a highly
selective positive allosteric modulator of the M4 muscarinic
receptor that Neumora is developing as a treatment for
schizophrenia and other neuropsychiatric disorders.
“The initiation of this Phase 1 study is an important step in
the development of NMRA-266. In pre-clinical studies NMRA-266
demonstrated a favorable pharmacologic profile that includes high
potency and selectivity for the M4 receptor subtype, meriting its
advancement into the clinic,” said Robert Lenz, M.D. Ph.D.,
executive vice president and head of research and development,
Neumora. “With its pre-clinical profile and clinical validation of
the M4 muscarinic receptor class in treating schizophrenia, we
believe that NMRA-266 has strong potential as a treatment for
neuropsychiatric disorders.”
Neumora believes that as a selective M4 receptor-positive
allosteric modulator, NMRA-266 has the potential to deliver
antipsychotic efficacy, while minimizing the side effects
associated with current antipsychotics and other non-selective
muscarinic agonists.
“Muscarinic receptor-targeting compounds have demonstrated
robust activity in multiple clinical trials, reinforcing the
potential of this class of medicines as an approach to treating
schizophrenia and other neuropsychiatric disorders,” said John H.
Krystal, M.D., Robert L. McNeil, Jr. Professor of Translational
Research and Professor of Psychiatry, of Neuroscience, and
Psychology, and chair of the Yale Department of Psychiatry at Yale
School of Medicine. “Schizophrenia is a serious and debilitating
disorder. Limitations in the effectiveness of existing treatments
result in significant unmet medical need. Pharmacologic treatment
is an integral part of a comprehensive treatment plan, and finding
the right treatment option for each patient is vitally important.
As such, it’s encouraging to see the development of multiple
products within the muscarinic class that may help people with
schizophrenia find a treatment that works for them.”
About NMRA-266NMRA-266 is an investigational
positive allosteric modulator of the M4 muscarinic receptor
subtype. While current antipsychotics approved for schizophrenia
work primarily by blocking D2 dopamine receptors, growing evidence
supports the approach of targeting the M4 muscarinic receptor to
elicit antipsychotic effects, without the side effects associated
with the first- and second-generation antipsychotics. M4 muscarinic
receptor-targeting compounds have shown robust antipsychotic
activity in multiple, placebo-controlled clinical trials,
demonstrating potential as an approach to treating schizophrenia.
Neumora exclusively licensed certain intellectual property rights
related to NMRA-266 from Vanderbilt University, including
composition of matter patent extending to 2042.
About Schizophrenia Schizophrenia is a
debilitating neuropsychiatric disorder characterized by positive
symptoms (such as delusions and hallucinations), negative symptoms
(such as diminished emotional expression) and cognitive symptoms
(such as deficits in types of memory) that impacts approximately 3
million adults in the United States. Currently approved therapies
for schizophrenia are often associated with potentially serious
side effects, including movement and metabolic effects, and no
therapies with a novel mechanism of action have been recently
approved. Significant unmet medical need remains in the treatment
of schizophrenia as a result of this paradigm. A study conducted by
the National Institute of Mental Health found that approximately 75
percent of people with schizophrenia discontinue medication within
18 months due in part to inefficacy or intolerable side
effects.
About NeumoraNeumora Therapeutics, Inc. is a
clinical-stage biopharmaceutical company founded to confront the
global brain disease crisis by taking a fundamentally different
approach to the way treatments for brain diseases are developed.
Our therapeutic pipeline currently consists of seven clinical and
preclinical neuroscience programs that target novel mechanisms of
action for a broad range of underserved neuropsychiatric disorders
and neurodegenerative diseases. Our work is supported by an
integrated suite of translational, clinical, and computational
tools to generate insights that can enable precision medicine
approaches. Neumora’s mission is to redefine neuroscience drug
development by bringing forward the next generation of novel
therapies that offer improved treatment outcomes and quality of
life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about Neumora Therapeutics, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including statements related to: Neumora’s intention to redefine
neuroscience drug development by bringing forward the next
generation of novel therapies that offer improved treatment
outcomes and quality of life for patients suffering from brain
diseases; the timing, progress and plans for its therapeutic
development programs, including the timing of initiation and data
read outs for its programs and studies, as well as its clinical
trial and development plans; the potential for NMRA-266 to be a
treatment for schizophrenia and other neuropsychiatric disorders;
the expected timing of patent protection for NMRA-266 and; other
statements identified by words such as “could,” “expects,”
“intends,” “may,” “plans,” “potential,” “should,” “will,” “would,”
or similar expressions and the negatives of those terms. Other than
statements of historical facts, all statements contained in this
press release, are forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These statements are subject to risks and
uncertainties that could cause the actual results or to be
materially different from the information expressed or implied by
these forward-looking statements, including, among others: the
risks related to the inherent uncertainty of clinical drug
development and unpredictability and lengthy process for obtaining
regulatory approvals; risks related to the timely initiation and
enrollment in our clinical trials; risks related to our reliance on
third parties, including CROs; risks related to serious or
undesirable side effects of our therapeutic candidates; risks
related to our ability to utilize and protect our intellectual
property rights; and other matters that could affect sufficiency of
capital resources to fund operations. For a detailed discussion of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Neumora’s business in general, please
refer to the risk factors identified in the Company’s filings with
the Securities and Exchange Commission (SEC), including but not
limited to its Registration Statement on Form S-1, as amended (File
No. 333-274229), filed with the SEC on September 11, 2023, and
related Prospectus dated September 14, 2023 filed under 424(b)(4)
of the Securities Act of 1933, as amended. Forward-looking
statements speak only as of the date hereof, and, except as
required by law, Neumora undertakes no obligation to update or
revise these forward-looking statements.
Neumora Contact:Helen RubinsteinMobile:
315-382-3979Helen.Rubinstein@neumoratx.com
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