TEL AVIV, Israel, March 12, 2019 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of the liver targeted SCD1 modulator, Aramchol, an oral therapy for
the treatment of nonalcoholic steatohepatitis ("NASH") and
fibrosis, announced today positive results from a pharmacokinetic
(PK) study showing that dose splitting of Aramchol 600mg to twice
daily 300mg significantly increased plasma levels.
The aim of this Phase I, open-label, two-period, randomized,
crossover PK study was to assess whether dose splitting of Aramchol
600mg to twice daily 300mg will significantly increase plasma
levels. 16 healthy subjects took part in two study periods. Eight
subjects received each regimen in the first period and the
alternate regimen in the second period. A PK profile was obtained
over the dosing interval at steady state on day ten of each
period.
Results of the study showed that the administration of Aramchol
300 mg twice daily resulted in 24-hour plasma concentrations
significantly greater than those observed with the administration
of Aramchol 600 mg once daily (P<0.0001). The average plasma
levels (exposure) were 53% higher and exposure was greater in all
16 subjects with the twice daily dosing. The treatment in both
dosing regimens was similar in terms of safety and was well
tolerated.
"As previously seen in our presentations, a dose response
pattern was observed in the recently completed Phase 2b ARREST study. Aramchol 600mg resulted in
higher efficacy compared to 400mg, with only a 20% elevation in
plasma levels. We find a further increase of 53% highly encouraging
as this implies the potential for significantly higher efficacy on
both NASH resolution and fibrosis improvement," stated Allen
Baharaff, Chief Executive Officer of Galmed.
"The results of this study were recently obtained and submitted
to the FDA. We are planning to discuss these new findings in
our forthcoming end of Phase 2b meeting," added Mr.
Baharaff.
About Aramchol™ and Non-alcoholic
Steatohepatitis (NASH)
Aramchol™ (arachidyl amido cholanoic acid) is a
novel fatty acid bile acid conjugate, inducing beneficial
modulation of intra-hepatic lipid metabolism.
Aramchol™'s ability to modulate hepatic lipid
metabolism was discovered and validated in animal models,
demonstrating down regulation of the three key pathologies of NASH;
steatosis, inflammation and fibrosis. The effect of
Aramchol™ on fibrosis is mediated by down regulation
of steatosis and directly on human collagen producing cells.
Aramchol™ has been granted by the FDA Fast Track
designation status for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5%
of the U.S. population and an estimated 2% to 4% globally. It is
the fastest growing cause of liver cancer and liver transplant in
the U.S. due to the rise in obesity. NASH is the progressive form
of non-alcoholic fatty liver disease that can lead to
cardiovascular disease, cirrhosis and liver-related mortality.
About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on
the development of Aramchol, a first in class, novel, oral therapy
for the treatment of NASH for variable populations. Galmed recently
announced top-line results of the ARREST Study, a multicenter,
randomized, double blind, placebo-controlled Phase 2b clinical study designed to evaluate the
efficacy and safety of Aramchol in subjects with NASH, who are
overweight or obese, and who are pre-diabetic or type-II-diabetic.
Galmed is currently preparing for an end of Phase 2b meeting with the FDA to discuss the results of
the ARREST Study and a Phase 3/4 study protocol, with a view to
initiating a Phase 3/4 clinical study of Aramchol in 2019.
Forward-Looking Statements:
This press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to Galmed's objectives, plans and strategies,
as well as statements, other than historical facts, that address
activities, events or developments that Galmed intends, expects,
projects, believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Many factors could cause Galmed's actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: the timing and cost of Galmed's
planned Phase 3/4 trial for Aramchol, or whether a Phase 3/4 trial
will be conducted at all; completion and receiving favorable
results of a Phase 3/4 trial for Aramchol or any other pre-clinical
or clinical trial; regulatory action with respect to Aramchol by
the FDA or the EMA; the commercial launch and future sales of
Aramchol or any other future products or product candidates;
Galmed's ability to comply with all applicable post-market
regulatory requirements for Aramchol in the countries in which it
seeks to market the product; Galmed's ability to achieve favorable
pricing for Aramchol; Galmed's expectations regarding the
commercial market for NASH; third-party payor reimbursement for
Aramchol; Galmed's estimates regarding anticipated capital
requirements and Galmed's needs for additional financing; market
adoption of Aramchol by physicians and patients; the timing, cost
or other aspects of the commercial launch of Aramchol; the
development and approval of the use of Aramchol for additional
indications or in combination therapy; and Galmed's expectations
regarding licensing, acquisitions and strategic operations. More
detailed information about the risks and uncertainties affecting
Galmed is contained under the heading "Risk Factors" included in
Galmed's most recent Annual Report on Form 20-F filed with the SEC
on March 13, 2018, and in other
filings that Galmed has made and may make with the SEC in the
future. The forward-looking statements contained in this press
release are made as of the date of this press release and reflect
Galmed's current views with respect to future events, and Galmed
does not undertake and specifically disclaims any obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/galmed-reports-positive-results-from-pharmacokinetic-split-dose-study-of-aramchol-300810755.html
SOURCE Galmed Pharmaceuticals Ltd.