Full Press Release Details
Enlivex Announces the Dosing of the First Patient
in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis
Nes-Ziona, Israel, November 14, 2024 (GLOBE NEWSWIRE)
-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company,
today announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating
the safety, tolerability and potential therapeutic effect of Allocetra following injection into an affected joint in patients with
psoriatic arthritis. No safety concerns were recorded following the dosing of the first patient.
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 .
Dr. Oren Hershkovitz, CEO, commented, "Complementing
our ongoing clinical trial in osteoarthritis, which is a low-grade chronic inflammatory joint disease, this new study provides an opportunity
to assess Allocetra in a high-grade inflammatory joint disease such as psoriatic arthritis, which is another indication with poor
treatment alternatives that we believe potentially presents a substantial market opportunity for 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, with certain projections indicating 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.
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 https://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 market opportunities for the results of current clinical studies and preclinical experiments and
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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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