Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis
July 23 2024 - 8:00AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a
clinical-stage macrophage reprogramming immunotherapy company,
today announced that the Israeli Ministry of Health has authorized
the initiation of a Phase I clinical trial to evaluate the safety
and tolerability of Allocetra™ following injection into an affected
joint in patients with psoriatic arthritis.
The trial currently plans to recruit six patients who have
insufficiently responded to conventional therapies for psoriatic
arthritis. The primary safety endpoint will measure the frequency
and severity of adverse events and serious adverse events, and
secondary endpoints will include assessments of change from
baseline in pain and other parameters of disease activity for up to
12 months following administration of Allocetra™.
“There are many psoriatic arthritis patients with poor response
to existing treatments. The mode of action of AllocetraTM may
become a new modality in treating these patients. We are pleased to
announce the initiation of a new clinical program in psoriatic
arthritis and are looking forward to commencing the study as a
first step to our future development of a potentially effective
treatment option for these patients” stated Oren Hershkovitz,
Ph.D., CEO of Enlivex.
ABOUT PSORIATIC ARTHRITIS1
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis
that typically occurs in individuals with psoriasis, a skin
condition characterized by red, scaly patches. PsA can affect any
joint in the body, leading to pain, stiffness, and swelling. It can
also cause inflammation in other parts of the body, including the
eyes, heart, and gastrointestinal tract. The global market for
psoriatic arthritis (PsA) treatments, valued at approximately $10.8
billion in 2023, is estimated to grow substantially. Certain
projections indicate the market will reach $20.5 billion by 2032,
growing at a compound annual growth rate (CAGR) of 7.4% from 2024
to 2032. Other analysis anticipates the PsA treatment market will
increase from $9.97 billion in 2023 to $24.87 billion by 2031,
representing a CAGR of 12.1% from 2024 to 2031. The current
landscape of PsA treatment is marked by significant challenges,
including limited efficacy, side effects, high costs, long-term
safety concerns, underdiagnosis, and issues with patient adherence.
Addressing these challenges requires ongoing research and
development of more effective, safer, and affordable treatments,
along with efforts to improve diagnosis and patient education.
ABOUT ALLOCETRA™
Allocetra™ is being developed as a universal,
off-the-shelf cell therapy designed to reprogram macrophages into
their homeostatic state. Diseases such as sepsis, osteoarthritis’
psoriatic arthritis and many others reprogram macrophages out
of their homeostatic state. These non-homeostatic macrophages
contribute significantly to the severity of the respective
diseases. By restoring macrophage homeostasis, and harnessing the
healing power of these cells, Allocetra™ has the potential to
provide a novel immunotherapeutic mechanism of action for
life-threatening and life-debilitating clinical indications that
are defined as “unmet medical needs,” as a stand-alone therapy or
in combination with leading therapeutic agents.
ABOUT ENLIVEX
Enlivex is a clinical stage macrophage reprogramming
immunotherapy company developing Allocetra™, a universal,
off-the-shelf cell therapy designed to reprogram macrophages into
their homeostatic state. Resetting non-homeostatic macrophages into
their homeostatic state is critical for immune system rebalancing
and resolution of life-threatening and life-debilitating
conditions. For more information, visit http://www.enlivex.com.
Safe Harbor Statement: This press release contains
forward-looking statements, which may be identified by words such
as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,”
“believes,” “should,” “would,” “could,” “intends,” “estimates,”
“suggests,” “has the potential to” and other words of similar
meaning, including statements regarding expected cash balances,
market opportunities for the results of current clinical studies
and preclinical experiments, the effectiveness of, and market
opportunities for, ALLOCETRATM programs. All such
forward-looking statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. Investors are cautioned that forward-looking statements
involve risks and uncertainties that may
affect Enlivex’s business and prospects, including the
risks that Enlivex may not succeed in generating any
revenues or developing any commercial products; that the products
in development may fail, may not achieve the expected results or
effectiveness and/or may not generate data that would support the
approval or marketing of these products for the indications being
studied or for other indications; that ongoing studies may not
continue to show substantial or any activity; and other risks and
uncertainties that may cause results to differ materially from
those set forth in the forward-looking statements. The results of
clinical trials in humans may produce results that differ
significantly from the results of clinical and other trials in
animals. The results of early-stage trials may differ significantly
from the results of more developed, later-stage trials. The
development of any products using the ALLOCETRATM product line
could also be affected by a number of other factors,
including unexpected safety, efficacy or manufacturing issues,
additional time requirements for data analyses and decision making,
the impact of pharmaceutical industry regulation, the impact of
competitive products and pricing and the impact of patents and
other proprietary rights held by competitors and other third
parties. In addition to the risk factors described above,
investors should consider the economic, competitive,
governmental, technological and other factors discussed
in Enlivex’s filings with the Securities and Exchange
Commission, including in the Company’s most recent Annual Report on
Form 20-F filed with the Securities and Exchange Commission.
The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements,
except as required under applicable law.
ENLIVEX CONTACTShachar Shlosberger, CFOEnlivex
Therapeutics, Ltd. shachar@enlivexpharm.com
INVESTOR RELATIONS CONTACTDave Gentry, CEO
RedChip Companies Inc. 1-407-644-4256 ENLV@redchip.com
1
https://www.yalemedicine.org/conditions/psoriatic-arthritishttps://www.reportsandinsights.com/report/psoriatic-arthritis-psa-treatment-markethttps://www.snsinsider.com/reports/psoriatic-arthritis-treatment-market-3223
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