Final publication in Neurology® of Phase 2a Results
Stratified by Plasma Phosphorylated Tau Status at Baseline
Strengthens the Case for Progressing Neflamapimod as a
Disease-Modifying Treatment for Dementia with Lewy Bodies
Research Highlight Article in Molecular Neurodegeneration
Comments That Through Acting on Cholinergic Degeneration
Neflamapimod Has Potential to have Disease-modifying Effects in
Both Dementia with Lewy Bodies and Alzheimer's Disease
BOSTON, Oct. 24,
2023 /PRNewswire/ -- CervoMed Inc. (NASDAQ:
CRVO), a clinical stage company focused on developing treatments
for degenerative diseases of the brain, today announced the
publication of the following two articles that support advancing
neflamapimod as a disease-modifying treatment for Dementia with
Lewy Bodies (DLB) and Alzheimer's Disease (AD):
- Alam JJ, Maruff P, Doctrow S, Chu H-M, Conway J, Gomperts SN,
Teunissen C. Association of plasma phosphorylated tau with the
response to neflamapimod treatment in patients with dementia with
Lewy bodies. Neurology, 2023, Volume 101, pages 1-10.
Neurology® is the medical journal of the
American Academy of Neurology. The journal has released
the final publication, including a Short Version in print, of the
article that was the subject of a press release from CervoMed
dated September 6th,
2023. The major finding is that the magnitude of the
neflamapimod treatment effect in the DLB phase 2a study in the
sub-group with normal plasma ptau181 at study entry (i.e., those
with pure DLB, without biomarker evidence of AD related
co-pathology) was greater than that seen in the overall study
population and substantial, with a treatment effect size relative
to placebo of at least 0.7 (indicative of a large effect) for each
of the measures of dementia severity, attention, recognition
memory, and functional mobility.
- Alam J and Nixon RA, Drug development targeting degeneration of
the basal forebrain cholinergic system: its time has come.
Molecular Neurodegeneration (2023) 18:74. This Research
Highlight article reviews the preclinical and clinical data in the
Neurology® publication and a prior publication in Nature
Communications and concludes that the findings are "a
major translational step forward" towards treating basal forebrain
cholinergic degeneration, the primary pathology in DLB and
considered to be a contributor to disease expression and/or
progression in multiple other CNS disorders, including AD.
"As reported in Nature Communications last year, the
primary analysis of the phase 2a study of DLB showed neflamapimod
significantly improved dementia severity and motor function. As now
published in the major clinical neurology journal,
Neurology, there is consistency and greater magnitude of the
clinical effect seen in patients without AD co-pathology, which
further strengthens the conclusions regarding the clinical effect
in DLB demonstrated in phase 2a," said John
Alam, MD, Chief Executive Officer of CervoMed and first
author of both publications announced today. He added, "The
Molecular Neurodegeneration article provides a combined
evaluation of the findings in the Neurology and Nature
Communications articles that makes the case for advancing
neflamapimod as a treatment for DLB. Further, the Molecular
Neurodegeneration article also comments that the results viewed
in the context of the broader scientific literature indicates that
neflamapimod also has potential to impact disease progression in
Alzheimer's disease, either as a standalone therapy or in
combination with amyloid beta directed therapies."
About CervoMed
CervoMed Inc. is a clinical-stage biotechnology company
advancing CNS-focused therapeutics to benefit patients with a range
of degenerative diseases of the brain. The Company is currently
developing neflamapimod, an investigational orally administered
small molecule brain penetrant that inhibits p38MAP kinase alpha
(p38a). Neflamapimod has the potential to treat synaptic
dysfunction, the reversible aspect of the underlying
neurodegenerative processes that cause disease in dementia with
Lewy bodies (DLB) and certain other major neurological disorders.
Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB (RewinD-LB Study).
CervoMed was formed in August 2023
with completion of the merger of EIP Pharma Inc. with Diffusion
Pharmaceuticals Inc.
For more information, please visit www.cervomed.com or engage
with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release includes express and implied forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, regarding the intentions, plans,
beliefs, expectations or forecasts for the future of CervoMed Inc.
(the "Company"), including, but not limited to, the therapeutic
potential of neflamapimod and anticipated timing of clinical
milestones. Terms such as "believes," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should," "approximately," "potential" or other words that convey
uncertainty of future events or outcomes may identify these
forward-looking statements. Although there is believed to be
reasonable basis for each forward-looking statement contained
herein, forward-looking statements by their nature involve risks
and uncertainties, known and unknown, many of which are beyond the
Company's control and, as a result, actual results could differ
materially from those expressed or implied in any forward-looking
statement. Particular risks and uncertainties include, among other
things, those related to: the Company's available cash resources
and the availability of additional funds on acceptable terms; the
likelihood and timing of any regulatory approval of neflamapimod or
the nature of any feedback the Company may receive from the U.S.
Food and Drug Administration; the ability to implement business
plans, forecasts, and other expectations in the future; general
economic, political, business, industry, and market conditions,
inflationary pressures, and geopolitical conflicts; and the other
factors discussed under the heading "Risk Factors" in Exhibit 99.2
to the Company's Current Report on Form 8-K/A filed with the U.S.
Securities and Exchange Commission (SEC) on September 29, 2023, and other filings that the
Company may file from time to time with the SEC. Any
forward-looking statements in this press release speak only as of
the date hereof (or such earlier date as may be identified).
The Company does not undertake any obligation to update such
forward-looking statements to reflect events or circumstances after
the date of this press release, except to the extent required by
law.
Additional Reference:
Jiang, Y, Alam, JJ, Gomperts SN et al., "Preclinical and
Randomized Clinical Evaluation of the p38α Kinase Inhibitor
Neflamapimod for Basal Forebrain Cholinergic Degeneration,"
Nature Communications, 13, Article number: 5308 (2022).
https://www.nature.com/articles/s41467-022-32944-3
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SOURCE CervoMed Inc.