- Results confirm 25 mg Namodenoson as optimal dose based on
MRI-PDFF analysis and liver enzymes, reduction of liver fibrosis
and resolving all cases of NASH; Namodenoson continues to
demonstrate a very good safety profile after drug
treatment
- Prof. Rifaat Safadi, study principal investigator: "I am
very pleased with these compelling data. The next clinical trial
protocol to advance Namodenoson in the treatment of NASH and NAFLD
is now being developed"
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 that the final data analysis 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) has been completed. As a
whole, the data show that Namodenoson at the 25 mg dose produced
statistically significant results in all measures of efficacy,
while also having a strong safety profile and well tolerated.
New data resulting from the final analysis included additional
results from MRI-PDFF (proton density fat fraction on magnetic
resonance imaging) and liver stiffness measured by CAP Fibroscan.
An evaluation based on per patient liver volume revealed that liver
fat volume decreased in the Namodenoson treated groups vs. the
placebo (12.5 mg=81.2; 25 mg =102.1, vs. placebo= 33.0) with a high
significance (12.5mg p=0.036; 25mg p=0.027, respectively). The
percentage of fat volume decrease was also statistically
significant, with the Namodenoson 12.5 mg group declining by 3.68%,
and the 25 mg group declining by 4.33% vs. the placebo at 2.61% (25
mg p=0.036). This provides additional support for the
anti-steatotic effect of Namodenoson and additional assurance that
25 mg is the more efficacious dose.
Namodenoson significantly reduced two liver
enzymes, aspartate aminotransferase (AST) and alanine
aminotransferase (ALT), which are elevated in a damaged liver, and
increased the anti-inflammatory cytokine adiponectin known also to
act as an anti-fibrotic factor. Serum adiponectin levels increased
in the 25 mg dose group by 220 ng/mL and the 12.5 mg dose group by
539 ng/mL (p=0.03). Adiponectin is a cytokine with robust
anti-inflammatory and anti-fibrotic effects that is used as a
biomarker in NAFLD/NASH trials. In addition, a dose response
decrease compared to placebo was observed, indicating a reduction
of hepatic inflammation was achieved:
- % of patients who reached ALT normalization
at follow up was 36.8% in the 25 mg dose vs. 10% in the placebo
(p=0.038). In the 12.5 mg dose, 23.8% was recorded at follow
up;
- ALT Change from baseline (CFB) and % change
from baseline (PCFB) - in the 25 mg group, CFB decreased by 15.4
U/L (p=0.066) and PCFB by 22% (p=0.079) compared to placebo (1.7
U/L, 3.0%, respectively). In the 12.5 mg group, a decrease CFB of
10.4 U/L and PCFB of 8.2% was recorded; and
- AST CFB and PCFB - in the 25 mg group, CFB
decreased by 8.1 U/L (p=0.03) and PCFB by 17.9% (p=0.05) compared
to placebo (increase of 0.3 U/L, decrease of 1.3%, respectively).
In the 12.5 mg group, a decrease in CFB of 7.4 U/L and PCFB of 8.1
% was recorded.
- Reduction of Liver Fibrosis
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 AST and ALT.
- Reduction of Liver Steatosis
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.
A linear decrease in body weight was recorded
in the 25 mg and 12.5 mg Namodenoson groups.
- A3 Adenosine Receptor (A3AR)
The A3AR biomarker was stable, demonstrating
the presence of the receptor after chronic treatment and reflecting
the validity of the target.
Namodenoson continued to be safe and very
well tolerated with no drug emergent severe adverse effects and no
hepatotoxicity.
“We are very pleased with these compelling data. The next
clinical trial protocol to advance Namodenoson in the treatment of
NASH and NAFLD is now being developed. With the clear need for
approved drugs in this indication, I believe distribution partners
for Can-Fite will likely take notice of these results,” 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. 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20200630005422/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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