Can-Fite’s Phase III Psoriasis Study Data Expected Q2 2022
March 08 2022 - 07:00AM
Business Wire
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 top line data from its Phase III
Comfort™ study of Piclidenoson in the treatment of
moderate-to-severe plaque psoriasis are scheduled to be released in
Q2 2022 due to an unanticipated delay in the collection of study
data. The study enrolled more than 400 patients across 30 sites in
Europe, Israel, and Canada.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor
agonist (A3AR) small molecule, orally bioavailable drug with a
mechanism of action involving inhibition of 2 cytokines,
interleukin-17 and interleukin-23, both pivotal for the formation
of skin lesions. Piclidenoson has also recently shown to induce
death of pathological skin cells.
The Comfort randomized, double blind, active and
placebo-controlled study’s primary endpoint is the proportion of
patients who achieve a PASI score response of ≥75% (PASI 75) vs.
placebo at week 16, and secondary endpoints include non-inferiority
to Otezla®, a leading oral drug on the market, at week 32.
Piclidenoson is administered twice daily orally.
“While we had been expecting to announce topline results in the
first quarter of 2022, it is taking longer than expected to gather
and tabulate the data from this 400-plus person international
study. We now expect to report results in the second quarter of
2022. We look forward to analyzing the data and are hopeful that
Piclidenoson may prove to be an effective treatment with minimal to
no side effects in the $11 billion psoriasis market,” stated
Can-Fite CEO Dr. Pnina Fishman.
Otezla reported generating $2.2 billion in sales in 2020.
According to iHealthcareAnalyst, the psoriasis therapeutic market
is estimated to reach $11.3 billion by 2025. Piclidenoson has been
out-licensed for the indication of psoriasis in major markets
including Canada, Europe, and Asia with deal terms including
potential upcoming milestone payments and double-digit royalties
upon regulatory approval.
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, is currently in a
Phase III trial for psoriasis. 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 a Phase IIb 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 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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