OnKai's AI models redefine the methodologies and economics of
clinical trials
TEL
AVIV, Israel, July 10,
2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage
biopharmaceutical company for liver, metabolic and fibrotic
diseases, is delighted to announce the first step in its strategic
partnership with OnKai, where OnKai will apply its artificial
intelligence (AI), models for enrollment and execution of clinical
trials in underserved communities, starting with Galmed's
innovative Primary Sclerosing Cholangitis (PSC) clinical
development program.
PSC is a rare, severe, chronic disease where progression is
predominantly determined by biliary fibrosis. There are currently
no approved drugs for the treatment of the disease, which gradually
progresses to cirrhosis, often requiring liver transplantation.
Aramchol has been shown to have anti-fibrotic effects in
pre-clinical models in NASH idiopathic pulmonary fibrosis (IPF) and
clinical studies in patients with NASH. The clinical development
for PSC is expected to start with a Phase 2a study to be conducted
at Virginia Commonwealth University
beginning in the fourth quarter of 2023, followed by a Phase 2/3
confirmatory adaptive design trial.
OnKai's innovative planning tool is anticipated to generate a
comprehensive enrollment plan for each trial phase utilizing five
new participation models that OnKai designed for integrating
underserved communities in clinical studies. OnKai's Smart-Grid AI
Platform will continuously support the trial in the selected local
clinics. Local clinics will receive the tools and fair compensation
to accompany their patients throughout the process, ensuring
individual needs are not disregarded.
The first of the five models to be applied by OnKai is
TrialBridge. TrialBridge serves as a conduit, seamlessly linking
free and available clinics with their patients to specialist
centers, leveraging the role of the community in a patient's
journey. This model enables patients equal access to quality care
and, where possible, to clinical trials while maintaining
continuity with their local clinic.
This collaboration presents a promising opportunity to foster
mutual benefits between Galmed, its principal sites, and the
relevant clinics in underserved communities.
Noam Smetana, OnKai CEO,
commented, "I am thrilled about the potential of this innovative
partnership to positively impact underserved communities across the
US in the coming years. We believe that our project with Galmed,
along with others at various stages in our pipeline, will
significantly advance health equity within the network of clinics
we collaborate with."
Allen Baharaff, CEO and President of Galmed Pharmaceuticals
commented, "We are enthusiastic about employing OnKai's
groundbreaking AI technology in our trial. The application of
OnKai's AI platform is still emerging but potentially disruptive
for the conduct of clinical trials. Not only does this partnership
allow us to include a diverse population in our trials, but it is
also expected that it will result in the faster approval and better
site performance."
About Galmed Pharmaceuticals Ltd.
We are a clinical stage biopharmaceutical company focused on the
development of Aramchol for liver and fibro-inflammatory diseases.
We have focused almost exclusively on developing Aramchol for the
treatment of NASH and are currently developing Aramchol for PSC and
exploring the feasibility of developing Aramchol for other
fibro-inflammatory indications outside of liver disease. We are
also collaborating with the Hebrew
University in the development of Amilo-5MER, a 5 amino acid
synthetic peptide.
Forward-Looking Statements:
Forward-looking statements relate to anticipated or expected
events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not
yet occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the
forward-looking statements. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, our ability to identify, evaluate and complete any
strategic alternative that yields value for our shareholders; the
timing and cost of our any pre-clinical or clinical trial, for our
product candidates; completion and receiving favorable results of
any pre-clinical or clinical trial; regulatory action with respect
to Aramchol or any other product candidate by the U.S. Food and
Drug Administration, or the FDA, or the European Medicines
Authority, or EMA, including but not limited to acceptance of an
application for marketing authorization, review and approval of
such application, and, if approved, the scope of the approved
indication and labeling; the commercial launch and future sales of
Aramchol and any future product candidates; our ability to comply
with all applicable post-market regulatory requirements for
Aramchol or any other product candidate in the countries in which
we seek to market the product; our ability to achieve favorable
pricing for Aramchol or any other product candidate; our
expectations regarding the commercial market for non-alcoholic
steato-hepatitis, or NASH, in patients or any other targeted
indication; third-party payor reimbursement for Aramchol or any
other product candidate; our estimates regarding anticipated
capital requirements and our needs for additional financing; market
adoption of Aramchol or any other product candidate by physicians
and patients; the timing, cost or other aspects of the commercial
launch of Aramchol or any other product candidate; our ability to
obtain and maintain adequate protection of our intellectual
property; the possibility that we may face third-party claims of
intellectual property infringement; our ability to manufacture our
product candidates in commercial quantities, at an adequate quality
or at an acceptable cost; our ability to establish adequate sales,
marketing and distribution channels; intense competition in our
industry, with competitors having substantially greater financial,
technological, research and development, regulatory and clinical,
manufacturing, marketing and sales, distribution and personnel
resources than we do; the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy; our ability to maintain the listing of
our ordinary share on The Nasdaq Capital Market; and our
expectations regarding licensing, acquisitions and strategic
operations. We believe these forward-looking statements are
reasonable; however, these statements are only current predictions
and are subject to known and unknown risks, uncertainties and other
factors that may cause our or our industry's actual results, levels
of activity, performance or achievements to be materially different
from those anticipated by the forward-looking statements. We
discuss many of these risks in our Annual Report on Form 20-F for
the year ended December 31, 2022
filed with the SEC on March 29, 2023
in greater detail under the heading "Risk Factors." Given these
uncertainties, you should not rely upon forward-looking statements
as predictions of future events. All forward-looking statements
attributable to us or persons acting on our behalf speak only as of
the date hereof and are expressly qualified in their entirety by
the cautionary statements included in this report. We undertake no
obligations to update or revise forward-looking statements to
reflect events or circumstances that arise after the date made or
to reflect the occurrence of unanticipated events. In evaluating
forward-looking statements, you should consider these risks and
uncertainties.
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SOURCE Galmed Pharmaceuticals Ltd.
