- All cases of NASH significantly resolved after 12 weeks of
treatment with Namodenoson 25 mg
- Namodenoson’s safety profile and efficacy in Phase II
position the drug for advanced clinical trials in the treatment of
NAFLD/NASH, a projected $35 billion market by 2025
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, today announced additional findings from its Phase II
study of Namodenoson in the treatment of patients with
non-alcoholic fatty liver disease (NAFLD) with or without
non-alcoholic steatohepatitis (NASH). On April 7, the Company
reported topline results from the Phase II study indicating
Namodenoson had achieved its efficacy endpoints in a dose dependent
and statistically significant manner, while continuing to
demonstrate a good safety profile. Most significantly, a more
recent in-depth review of the Phase II data reveal 25 mg of
Namodenoson was found to resolve significantly all cases of NASH,
representing 25% of the 25 mg treated group, as compared to an
increase in new NASH cases in the placebo group from a baseline of
0 to 5.9%.
In the Phase II study, 25 mg of Namodenoson was shown to reduce
hepatic fibrosis (scar tissue in the liver resulting from the liver
trying to repair itself), reduce steatosis (fat buildup in the
liver), and improve the FAST score, a measure for NASH (liver
stiffness and an enzymatic biomarker of liver damage).
Patients treated with 25 mg of Namodenoson
had a statistically significant reduction in hepatic fibrosis as
measured by the Fibrosis-4 (FIB-4) score, as compared to placebo.
FIB-4 change from baseline improved by -0.089 in patients dosed
with 25 mg of Namodenoson, as compared to the placebo group which
deteriorated from baseline by 0.042 points, with p=0.026. FIB-4 is
a non-invasive marker of hepatic fibrosis consisting of four
parameters including age, platelet counts, and two liver enzymes,
aspartate aminotransferase (AST) and alanine aminotransferase
(ALT), which are elevated in a damaged liver.
In the Namodenoson 25 mg treated group, the
proportion of patients with high steatosis scores declined from
37.5% to 13.3% of the population, as compared to the placebo
treated group in which the proportion of patients with high
steatosis scores decreased from 37.5% to 35.3% of the population,
with p=0.08. Steatosis was assessed by Controlled Attenuation
Parameter (CAP) measurement of the FibroScan, a non-invasive marker
of hepatic steatosis.
- NASH – All Cases Resolved
25% of patients randomized into the
Namodenoson 25 mg dosed group had NASH at baseline, as compared to
none in the placebo group, which comprised of patients who had
NAFLD without NASH at baseline. Following 12 weeks of treatment,
all NASH cases were resolved in patients treated with 25 mg of
Namodenoson, as compared to new NASH that developed in the placebo
group representing 5% of that population, with p<0.009. NASH was
evaluated by FibroScan-AST (FAST) score, a noninvasive marker of
NASH, the severe form of NAFLD (equivalent to biopsy findings of
NAS≥4, F≥2), measured by FibroScan elastography, CAP and serum
AST.
“The data show that Namodenoson reversed and eliminated NASH,
and may prevent the progression of NAFLD into NASH. We are very
pleased and impressed by these results. Given the clear need for
approved drugs in this indication, we believe Namodenoson is a
strong candidate for advanced stage clinical development as a
treatment for both NAFLD and NASH,” stated Prof. Rifaat Safadi of
Hadassah Medical Center, the Principal Investigator of the
study.
The Phase II double-blind, placebo-controlled, dose-finding
efficacy and safety study enrolled 60 patients with NAFLD with or
without NASH in three clinical sites in Israel. Patients with
evidence of an active inflammation were treated twice daily with
12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs. placebo
(n=20). The patients were treated for 12 weeks and followed-up
until week 16. The study’s end points included alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) blood
level, % of liver fat, liver stiffness, serum adiponectin, leptin
and patient’s weight loss. Based on topline results, 25 mg was
determined to be the optimal dosage.
An estimated 85 million Americans have NAFLD, which may lead to
an exponential rise in incidence of NASH, a more severe form of
NAFLD, to close to 43 million Americans in the next five years. The
NASH treatment market is estimated to reach $35-40 billion by
2025.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multi-billion dollar markets
in the treatment of cancer, inflammatory disease and COVID-19. The
Company's lead drug candidate, Piclidenoson, is currently in Phase
III trials for rheumatoid arthritis and psoriasis. Piclidenoson has
been approved for a pilot clinical trial in Israel to treat
COVID-19 infected patients with moderate-to-severe symptoms.
Can-Fite's liver drug, Namodenoson, is headed into a Phase III
trial for hepatocellular carcinoma (HCC), the most common form of
liver cancer, and successfully achieved its primary endpoint in a
Phase II trial for the treatment of non-alcoholic steatohepatitis
(NASH). Namodenoson has been granted Orphan Drug Designation in the
U.S. and Europe and Fast Track Designation as a second line
treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat
other cancers including colon, prostate, and melanoma. CF602, the
Company's third drug candidate, has shown efficacy in the treatment
of erectile dysfunction. These drugs have an excellent safety
profile with experience in over 1,500 patients in clinical studies
to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite’s expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product
development efforts, business, financial condition, results of
operations, strategies or prospects. In addition, from time to
time, Can-Fite or its representatives have made or may make
forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words
such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or
“anticipate” or their negatives or other variations of these words
or other comparable words or by the fact that these statements do
not relate strictly to historical or current matters. These
forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or
with the approval of one of Can-Fite’s authorized executive
officers. 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 Can-Fite’s actual results
to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause
Can-Fite’s actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ
materially from those expressed or implied in such forward-looking
statements include, but are not limited to: our history of losses
and needs for additional capital to fund our operations and our
inability to obtain additional capital on acceptable terms, or at
all; uncertainties of cash flows and inability to meet working
capital needs; the impact of the recent outbreak of coronavirus;
the initiation, timing, progress and results of our preclinical
studies, clinical trials and other product candidate development
efforts; our ability to advance our product candidates into
clinical trials or to successfully complete our preclinical studies
or clinical trials; our receipt of regulatory approvals for our
product candidates, and the timing of other regulatory filings and
approvals; the clinical development, commercialization and market
acceptance of our product candidates; our ability to establish and
maintain strategic partnerships and other corporate collaborations;
the implementation of our business model and strategic plans for
our business and product candidates; the scope of protection we are
able to establish and maintain for intellectual property rights
covering our product candidates and our ability to operate our
business without infringing the intellectual property rights of
others; competitive companies, technologies and our industry;
statements as to the impact of the political and security situation
in Israel on our business; and risks and other risk factors
detailed in Can-Fite’s filings with the SEC and in its periodic
filings with the TASE. In addition, Can-Fite operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control.
Can-Fite does not undertake any obligation to publicly update these
forward-looking statements, whether as a result of new information,
future events or otherwise.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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