Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biopharma company
developing cellular therapies for aging-related illnesses, chronic
disorders, and other specific life-threatening conditions,
announced the publication of results from a Phase 1 trial testing
Lomecel-B on patients with mild Alzheimer’s disease (AD) in
Alzheimer’s & Dementia®: The Journal of the Alzheimer’s
Association. The trial met its primary endpoint, demonstrating that
Lomecel-B was well tolerated in this patient population. In
addition, the data provided indications supporting further
exploration of Lomecel-B, particularly the therapeutic potential to
slow cognitive decline and improve quality of life in patients with
AD.
“We are pleased and encouraged by the
publication of our study in this high-impact journal,” said Geoff
Green, CEO of Longeveron. “The Lomecel-B study was funded by two
competitive Part the Cloud Neuroinflammation Challenge grants
awarded to Longeveron from the Alzheimer’s Association, for which
we are extremely grateful.”
The article, titled “Results and Insights from a
Phase 1 Clinical Trial of Lomecel-B for Alzheimer’s disease,”
details the study findings on Longeveron’s lead investigational
product, Lomecel-B, an allogeneic bone marrow-derived medicinal
signaling cell (MSC) product, given to patients with mild
Alzheimer’s disease.
“What makes this study unique is the use of a
cellular therapy that may potentially target multiple pathological
features of Alzheimer’s disease simultaneously,” said Dr. Mark
Brody, lead author of the manuscript. “Not only did the study meet
its primary endpoint of safety, but it also suggests the potential
that Lomecel-B could have in treating patients with Alzheimer’s
disease. We found data suggesting that Lomecel-B could have effects
ranging from increasing blood vessel health to reducing
inflammation, which could yield promising results.”
The double-blinded, randomized,
placebo-controlled trial was conducted on thirty-three patients at
four clinical sites. Each patient received a single intravenous
infusion of low- or high-dose Lomecel-B, or a placebo. The findings
from this study are being tested in a new larger Phase 2 study,
which commenced in December 2021, and has already treated the first
patient and continues to enroll others. The new trial is
double-blinded, randomized, and placebo-controlled, and is designed
to evaluate single versus multiple doses of Lomecel-B for mild
Alzheimer’s disease.
The major findings of the Phase 1 study as
reported in Alzheimer’s & Dementia are as follows:
-
The primary endpoint -- safety -- was met. The Lomecel-B infusion
was well-tolerated, and there were no treatment-related safety
concerns. Importantly, patients receiving Lomecel-B were not
reported to develop a serious side-effect called amyloid-related
imaging abnormalities (ARIA) as assessed by magnetic resonance
imaging (MRI). Other classes of Alzheimer’s drugs being tested have
been reported to cause ARIA.
-
Other exploratory findings included:
-
The Mini Mental State Exam (MMSE), used to evaluate cognitive
status, showed a slower decline in the low-dose Lomecel-B group
versus the placebo group.
-
The Quality of Life in Alzheimer Disease (QOL-AD), used to evaluate
patient well-being, showed a significantly higher (better) score in
the low-dose Lomecel-B group versus the placebo group at six months
after the single treatment.
-
Brain imaging by magnetic resonance imaging (MRI) showed an
increase in left hippocampus volume three months after a Lomecel-B
infusion in the high-dose Lomecel-B arm versus placebo. The
hippocampus is a brain region critical for memory formation, which
normally undergoes rapid neuron formation known as neurogenesis.
This process is damaged in Alzheimer’s disease, leading patients to
have reductions in the size of their hippocampus.
“We are encouraged by these results,” said Dr.
Anthony Oliva, Senior Scientist at Longeveron, and principal
investigator on the grants. “With a single dose of Lomecel-B, we
observed several lines of preliminary evidence supporting multiple
mechanisms of action of Lomecel-B, and most importantly, the data
supports the potential of Lomecel-B as disease modifying for
Alzheimer’s.”
The results of this study could have important
implications for combatting this devastating disease that is also
taking a significant toll on healthcare systems. According to a
recent report by the Alzheimer’s Association, an estimated 6.5
million Americans age sixty-five and older are living with dementia
due to Alzheimer’s disease. Seventy-three percent are age
seventy-five or older. Of the total U.S. population, about 1in 9
people (11.3%) age sixty-five and older has dementia due to
Alzheimer’s disease.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology
company developing cellular therapies for specific aging-related
and life-threatening conditions. The Company’s lead investigational
product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”),
which is derived from culture-expanded medicinal signaling cells
(MSCs) that are sourced from bone marrow of young, healthy adult
donors. Longeveron believes that by using the same cells that
promote tissue repair, organ maintenance, and immune system
function, it can develop safe and effective therapies for some of
the most difficult disorders associated with the aging process and
other medical disorders. Longeveron is currently sponsoring Phase 1
and 2 clinical trials in the following indications: Aging Frailty,
Alzheimer’s disease, and hypoplastic left heart syndrome (HLHS).
The Company’s mission is to advance Lomecel-B and other cell-based
product candidates into pivotal Phase 3 trials, with the goal of
achieving regulatory approvals, subsequent commercialization and
broad use by the healthcare community. Additional information about
the Company is available at http://www.longeveron.com/.
Forward-Looking Statements
Certain statements in this press release that
are not historical facts are forward-looking statements that
reflect management's current expectations, assumptions, and
estimates of future 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. Moreover,
forward-looking statements in this release include, but are not
limited to, statements about the ability of our clinical trials to
demonstrate safety and efficacy of our product candidates, and
other positive results; the timing and focus of our ongoing and
future preclinical studies and clinical trials; the size of the
market opportunity for our product candidates, the beneficial
characteristics, safety, efficacy and therapeutic effects of our
product candidates; our need and ability to raise additional
capital to fund operations; our ability to obtain and maintain
regulatory approval of our product candidates, our plans and
ability to obtain or protect intellectual property rights,
including extensions of existing patent terms where available and
our ability to avoid infringing the intellectual property rights of
others. 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 SEC. 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.
Media Contacts:
Eric KimSenior Vice PresidentOffice Direct:
212-805-3052ekim@rubensteinpr.com
Brigit Hennaman Vice PresidentOffice Direct:
212-805-3005bhennaman@rubensteinpr.com
Investor Contact:
Brendan PayneStern Investor Relations,
Inc.Office Direct: 212-698-8695 | Office Main:
212-362-1200brendan.payne@sternir.com | www.sternir.com
Source: Longeveron IncSource: LGVN
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