Can-Fite Completes Patient Enrollment in Phase III Psoriasis Study
September 02 2021 - 7:00AM
Business Wire
- Positive interim analysis data was released in October 2020
based on results from 200 patients
- Topline results expected Q1 2022
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 it has completed enrollment of all
patients (>400) planned for its Phase III Comfort™ study in
patients with moderate to severe plaque psoriasis.
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Image from prior Phase II clinical trial
of Piclidenoson of patient’s skin before treatment and at week 12
following treatment (Photo: Business Wire)
Positive interim data analysis from this Phase III study was
released by Can-Fite in October 2020. The Independent Data
Monitoring Committee (IDMC) conducted a pre-planned interim
analysis of 200 patients’ data and recommended, based on the
positive data, to continue the study. At this point, the Company
has completed the enrolment of all patients for this study and
plans to release topline results in Q1 2022.
The randomized, double blind, active and placebo controlled
study is being conducted in Europe, Israel, and Canada. The study’s
primary endpoint is the proportion of patients who achieve a PASI
score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary
endpoints include non-inferiority to Otezla® in weeks 16 and 32.
Patients enrolled in the study have been selected based on their
over-expression of the A3 adenosine receptor (A3AR), Can-Fite’s
therapeutic target.
“Because psoriasis is a chronic condition, it’s important for
effective treatments to also show good safety and minimal side
effects as they are used long term. While injectable biologics have
been effective, their potential side effects make them less optimal
for long-term use. We believe that based on the positive interim
analysis, Piclidenoson, as a small molecule oral drug, shows great
potential to demonstrate both efficacy and safety. We look forward
to announcing topline results in the first quarter of 2022,” stated
Can-Fite CEO Dr. Pnina Fishman.
Otezla generated $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 Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor
agonist (A3AR) small molecule, orally bioavailable drug with a
favorable therapeutic index demonstrated in Phase II clinical
studies. It is currently being evaluated in a multinational Phase
III study as a treatment for moderate to severe psoriasis and a
Phase II U.S. study for the treatment of moderate to severe
COVID-19.
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, inflammatory disease and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for psoriasis and a Phase II study
in the treatment of moderate COVID-19. 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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