Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative
medicine biotechnology company developing cellular therapies for
life-threatening and chronic aging-related conditions, announced
that its positive Phase 2a clinical trial data and biomarker
results were featured in two presentations, including a Featured
Research Session oral presentation, at the Alzheimer’s Association
International Conference® (AAIC), taking place July 28 – August 1,
2024, in Philadelphia and online.
“As a medicinal signaling cell therapy that has
multiple potential mechanisms of action to address inflammatory
responses in the brain, Lomecel-B™ offers potential to address the
underlying pathology of Alzheimer’s Disease without the limitations
of previous therapies,” said Wa’el Hashad, Chief Executive Officer
at Longeveron. “We are very encouraged by the safety profile and
efficacy evidence that support the differentiated therapeutic
potential of Lomecel-B™ and lay the foundation for its future
clinical development. We’re pleased to connect with the Alzheimer’s
community at AAIC 2024 and contribute to the growing body of
evidence that fuels the continued development of novel therapeutics
for this devastating disease.”
The randomized, placebo-controlled Phase 2a
CLEAR MIND trial evaluated a total of 48 patients (36 were treated
with Lomecel-B™ and 12 received placebo) who were 60-85 years old
and had a diagnosis of mild Alzheimer’s Disease in accordance with
National Institutes of Health – Alzheimer’s Association (NIA-AA)
criteria, a Mini-Mental State Examination (MMSE) score of 18-24,
and a brain MRI and positron emission tomography (PET) scan
consistent with Alzheimer’s Disease. The clinical trial achieved
its primary safety and secondary efficacy endpoints, and the study
results presented at AAIC 2024 support the therapeutic potential of
Lomecel-B™. Key findings include:
- The established safety profile of
Lomecel-B™ for single and multiple dosing regimens was demonstrated
in study data that showed no incidence of hypersensitivity,
infusion-related reactions, and no cases of amyloid-related imaging
abnormalities (ARIA).
- Patients treated with Lomecel-B™
showed an overall slowing of disease worsening compared to
placebo.
- Positive efficacy results were
demonstrated via a change from baseline at week 39 of the trial at
prespecified levels using the Composite Alzheimer’s Disease Score
(CADS) – a secondary outcome measure that combines information
across cognitive, functional capacity, and brain MRI domains.
- Administration of Lomecel-B™ was
associated with slowing cognitive and functional decline as
demonstrated by statistically significant results in the Montreal
Cognitive Assessment and statistical trending improvements compared
to placebo in CDR-SB and MMSE.
- There was a statistically
significant improvement relative to placebo observed in the
Alzheimer’s Disease Cooperative Study Activities of Daily Living
(ADCS-ADL).
- Lomecel-B™ minimized the loss in
brain volume in areas associated with Alzheimer’s Disease (TBV,
Hippocampus, Ventricles, Thalamus), statistically significant for
left hippocampal volume relative to placebo. Along with positive
changes in brain volumes, there was 20-30% reduction in left and
right ventricular enlargement, respectively.
- Diffusion tensor imaging MRI
supports the concept that Lomecel-B™ has the potential to reduce
neuroinflammation compared to placebo.
- Lomecel-B™ treated patients
demonstrated a numerical improvement relative to placebo in quality
of life observed by caregivers and measured by the Alzheimer’s
Disease Related Quality of Life (ADRQOL) and Quality of life AD
(QOL-AD) scales.
“In recent years, we’ve seen an enhanced
industry focus on bringing novel Alzheimer’s Disease therapeutics
to market to treat the millions of people who suffer each year,”
said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron.
“The emergence of new Alzheimer’s Disease therapies has
demonstrated that we are increasingly capable of treating a
condition once deemed untreatable, and the next step in this
endeavor is to develop a therapeutic that is both safe and
effective in treating this disease. The results from the Phase 2a
CLEAR MIND trial are highly encouraging and demonstrate the
potential of Lomecel-B™ to fulfill this need, and I look forward to
its continued development.”
“We believe these results provide important
validation of both the safety and therapeutic potential of
Lomecel-B™ in the treatment of mild Alzheimer’s Disease and
suggest, with further clinical evaluation, that this cellular
therapy has the potential to have a positive impact on patients
afflicted with this devastating disease,” said Joshua Hare, M.D.,
Co-founder, Chief Science Officer, and Chairman at Longeveron. “We
look forward to meeting the FDA to review this data and discuss the
future development path for Lomecel-B™ in Alzheimer’s Disease.”
The FDA has granted Lomecel-B™ both Regenerative
Medicine Advanced Therapy (RMAT) designation and Fast Track
designation for the treatment of mild Alzheimer’s Disease, which
allow greater access to the FDA during Lomecel-BTM’s development
for Alzheimer’s Disease.
About Lomecel-B™Lomecel-B™ is a
living cell product made from specialized cells isolated from the
bone marrow of young healthy adult donors. These specialized cells,
known as medicinal signaling cells (MSCs), are essential to our
endogenous biological repair mechanism. MSCs have been shown to
perform a number of complex functions in the body, including the
formation of new tissue. They also have been shown to respond to
sites of injury or disease and secrete bioactive factors that are
immunomodulatory and regenerative. We believe that Lomecel-B™ may
have multiple potential mechanisms of action that may lead to
anti-inflammatory, pro-vascular regenerative responses, and
therefore may have broad application for a range of rare and aging
related diseases.
About Longeveron Inc.Longeveron
is a clinical stage biotechnology company developing regenerative
medicines to address unmet medical needs. The Company’s lead
investigational product is Lomecel-B™, an allogeneic medicinal
signaling cell (MSC) therapy product isolated from the bone marrow
of young, healthy adult donors. Lomecel-B™ has multiple potential
mechanisms of action encompassing pro-vascular, pro-regenerative,
anti-inflammatory, and tissue repair and healing effects with broad
potential applications across a spectrum of disease areas.
Longeveron is currently pursuing three pipeline indications:
hypoplastic left heart syndrome (HLHS), Alzheimer’s Disease, and
Aging-related Frailty. Lomecel-BTM development programs have
received five separate and distinct FDA designations: for the HLHS
program - Orphan Drug designation, Fast Track designation, and Rare
Pediatric Disease designation; and, for the Alzheimer’s Disease
program - Regenerative Medicine Advanced Therapy (RMAT) designation
and Fast Track designation. For more information, visit
www.longeveron.com or follow Longeveron on LinkedIn, X, and
Instagram.
Forward-Looking Statements
Certain statements in this press release that
are not historical facts are forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, which reflect management’s current
expectations, assumptions, and estimates of future operations,
performance and economic conditions, and involve risks and
uncertainties that could cause actual results to differ materially
from those anticipated by the statements made herein.
Forward-looking statements are generally identifiable by the use of
forward-looking terminology such as “believe,” “expects,” “may,”
“looks to,” “will,” “should,” “plan,” “intend,” “on condition,”
“target,” “see,” “potential,” “estimates,” “preliminary,” or
“anticipates” or the negative thereof or comparable terminology, or
by discussion of strategy or goals or other future events,
circumstances, or effects and include, but are not limited to, the
potential for Lomecel-B™ to be an effective treatment for
Alzheimer’s Disease or achieve U.S. FDA approval as a Regenerative
Medicine Advanced Therapy (RMAT). Factors that could cause actual
results to differ materially from those expressed or implied in any
forward-looking statements in this release include, but are not
limited to, market and other conditions, our limited operating
history and lack of products approved for commercial sale; adverse
global conditions, including macroeconomic uncertainty; inability
to raise additional capital necessary to continue as a going
concern; our history of losses and inability to achieve
profitability going forward; the absence of FDA-approved
allogeneic, cell-based therapies for Aging-related Frailty,
Alzheimer’s Disease, or other aging-related conditions, or for HLHS
or other cardiac-related indications; ethical and other concerns
surrounding the use of stem cell therapy or human tissue; our
exposure to product liability claims arising from the use of our
product candidates or future products in individuals, for which we
may not be able to obtain adequate product liability insurance; the
adequacy of our trade secret and patent position to protect our
product candidates and their uses: others could compete against us
more directly, which could harm our business and have a material
adverse effect on our business, financial condition, and results of
operations; if certain license agreements are terminated, our
ability to continue clinical trials and commercially market
products could be adversely affected; the inability to protect the
confidentiality of our proprietary information, trade secrets, and
know-how; third-party claims of intellectual property infringement
may prevent or delay our product development efforts; intellectual
property rights do not necessarily address all potential threats to
our competitive advantage; the inability to successfully develop
and commercialize our product candidates and obtain the necessary
regulatory approvals; we cannot market and sell our product
candidates in the U.S. or in other countries if we fail to obtain
the necessary regulatory approvals; final marketing approval of our
product candidates by the FDA or other regulatory authorities for
commercial use may be delayed, limited, or denied, any of which
could adversely affect our ability to generate operating revenues;
we may not be able to secure and maintain research institutions to
conduct our clinical trials; ongoing healthcare legislative and
regulatory reform measures may have a material adverse effect on
our business and results of operations; if we receive regulatory
approval of Lomecel-B™ or any of our other product candidates, we
will be subject to ongoing regulatory requirements and continued
regulatory review, which may result in significant additional
expense; being subject to penalties if we fail to comply with
regulatory requirements or experience unanticipated problems with
our therapeutic candidates; reliance on third parties to conduct
certain aspects of our preclinical studies and clinical trials;
interim, “topline” and preliminary data from our clinical trials
that we announce or publish from time to time may change as more
data become available and are subject to audit and verification
procedures that could result in material changes in the final data;
the volatility of price of our Class A common stock; we could lose
our listing on the Nasdaq Capital Market; provisions in our
certificate of incorporation and bylaws and Delaware law might
discourage, delay or prevent a change in control of our company or
changes in our management and, therefore, depress the market price
of our Class A common stock; we have never commercialized a product
candidate before and may lack the necessary expertise, personnel
and resources to successfully commercialize any products on our own
or together with suitable collaborators; and in order to
successfully implement our plans and strategies, we will need to
grow our organization, and we may experience difficulties in
managing this growth. Further information relating to factors that
may impact the Company’s results and forward-looking statements are
disclosed in the Company’s filings with the Securities and Exchange
Commission, including Longeveron’s Annual Report on Form 10-K for
the year ended December 31, 2023, filed with the Securities and
Exchange Commission on February 27, 2024, as amended by the Annual
Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports
on Form 10-Q, and its Current Reports on Form 8-K. The
forward-looking statements contained in this press release are made
as of the date of this press release, and the Company disclaims any
intention or obligation, other than imposed by law, to update or
revise any forward-looking statements, whether as a result of new
information, future events, or otherwise.
Investor Contact:Derek ColeInvestor Relations
Advisory Solutionsderek.cole@iradvisory.com
Media Contact:Andrea CohenSam Brown Inc.
Healthcare Communicationsandreacohen@sambrown.com (917)
209-7163
Photos accompanying this announcement are available at
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