Further analysis of Phase III
COMFORT™ data show Piclidenoson’s superior safety
profile and higher patient compliance compared to
Otezla®
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, announced today that it is planning to submit its
registration plans to the U.S. Food and Drug Administration (FDA)
and a Marketing Authorization Application (MAA) with the European
Medicines Agency (EMA) for its lead drug candidate Piclidenoson in
the treatment of moderate to severe psoriasis.
Can-Fite recently reported topline results from its Phase III
COMFORT™ study which met its primary endpoint with statistically
significant improvement over placebo in psoriasis patients and an
excellent safety profile for Piclidenoson. Further analysis of the
Phase III COMFORT™ data point towards a better safety profile for
Piclidenoson as compared to Otezla, which induced gastro-intestinal
adverse events in 6% of patients compared with 1% in patients
treated with placebo or Piclidenoson. Discontinuation of treatment
amongst patients treated with Otezla was significantly higher
compared to that of the Piclidenoson treated patients.
A sub-analysis of the efficacy data that divided patients into
those who had PASI>25 (more severe psoriasis) and PASI<25
(less severe) at baseline revealed that patients who started with
higher PASI values at entry benefitted more from treatment with
Piclidenoson as compared to placebo. This result demonstrates the
efficacy of Piclidenoson in the treatment of patients with more
severe disease.
In its registration plans, Can-Fite will submit the final
efficacy and safety results from COMFORT™, a multicenter,
randomized, placebo- and active-controlled, double-blind study that
assessed the efficacy and safety of Piclidenoson in more than 400
adults with moderate to severe plaque psoriasis together with a
request for registration advice to the FDA and EMA. Additionally,
current chemistry, manufacturing, and controls (CMC), nonclinical
data, and human pharmacokinetic data will be submitted to the
agencies along with a pivotal Phase III protocol and other
supporting clinical pharmacology plans.
“The additional safety and efficacy data that emerged following
our topline Phase III results point to a strong market positioning
for Piclidenoson among approved oral psoriasis drugs. Today, a
large percentage of people living with psoriasis choose not to be
treated with biologics due to reported serious side effects and the
need to be treated in a clinic. Similarly, a percentage of patients
using Otezla, the leading oral drug for psoriasis, suffer from
gastrointestinal issues and discontinue treatment. We believe that
if Piclidenoson achieves its primary endpoint once again in an
upcoming pivotal Phase III study, Piclidenoson will offer a safe
and effective long-term treatment for people living with psoriasis,
including those with the most severe cases,” stated Can-Fite
Medical Director, Dr. Michael Silverman.
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor
agonist (A3AR) small molecule, orally bioavailable drug with an
excellent safety profile demonstrating evidence of efficacy in
Phase II clinical studies. The drug’s mechanism of action entails
inhibition of the inflammatory cytokines interleukin 17 and 23
(IL-17 and IL-23) and the induction of apoptosis of patients’ skin
cell keratinocytes involved with the disease pathogenicity.
About the Phase III COMFORT™ Study
The COMFORT™ CF101-301PS, is a Phase III randomized,
double-blind, placebo- and active-controlled study of the efficacy
and safety of daily Piclidenoson (CF101) administered orally in
patients with moderate-to-severe plaque psoriasis. The primary
objectives of this study are to evaluate the efficacy of oral
Piclidenoson 2 mg or 3 mg twice daily (BID) in patients with
moderate-to-severe plaque psoriasis, compared with placebo, as
determined by the proportion of subjects who achieve a Psoriasis
Area and Severity Index (PASI) score response of ≥75% (PASI 75) at
Week 16 (superiority); and evaluate the safety of oral Piclidenoson
in this patient population. The secondary objectives of this study
are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID,
compared with placebo, as determined by the proportion of subjects
who achieve, respectively, PASI 50, Physician Global Assessment
(PGA) score of 0 or 1, and improvement on the Psoriasis Disability
Index (PDI) at Week 16 (superiority); evaluate the efficacy of oral
Piclidenoson 2 mg or 3 mg BID, compared with Otezla (apremilast),
as determined by the proportion of subjects who achieve PASI 75,
PGA score of 0 or 1, PASI 50, and improvement in PDI at Weeks 16
and 32 (non-inferiority); and evaluate the efficacy and safety data
for Piclidenoson through the extension period of up to 48 weeks of
treatment.
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, liver, and inflammatory disease. The
Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite's
liver drug, Namodenoson, is being evaluated in a Phase IIb trial
for the treatment of non-alcoholic steatohepatitis (NASH), and
enrollment is expected to commence in a Phase III trial for
hepatocellular carcinoma (HCC), the most common form of liver
cancer. 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 COVID-19 pandemic; 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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