Can-Fite Announces Positive Phase III Psoriasis Interim Data Analysis
October 06 2020 - 7:30AM
Business Wire
- Independent Data Monitoring Committee (IDMC) conducted a
pre-planned interim analysis of the Company’s Phase III Comfort™
trial of Piclidenoson for the treatment of psoriasis and
recommended to continue with this psoriasis study
- A separate IDMC for the pre-planned interim analysis of the
Acrobat™ Rheumatoid Arthritis (RA) Phase III study recommended not
to continue this study. The Company plans to undertake a detailed
analysis of the data of the RA study and decide on the next
steps.
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 Independent Data Monitoring
Committee (IDMC) which conducted an interim analysis of the
Company’s Phase III Comfort™ trial of Piclidenoson in the treatment
of moderate-to-severe plaque psoriasis, recommended, based on the
positive data, to continue the study with the original sample size
and drop one dose group. This means that an optimal dose has been
found and that the study can be concluded earlier than has been
originally planned.
A separate IDMC for the interim analysis of the Acrobat™
Rheumatoid Arthritis Phase III study recommended not to continue
this study. The Company plans to undertake a detailed analysis of
the data of the RA study and decide on the next steps.
Can-Fite’s Comfort™ Phase III psoriasis study is designed to
establish Piclidenoson’s superiority compared to placebo and
non-inferiority compared to Apremilast (Otezla®) in patients with
moderate to severe plaque psoriasis. The randomized, double blind
study is being conducted in Europe, Israel, and Canada. Patients
were randomized into four groups: 2 mg Piclidenoson, 3 mg
Piclidenoson, Otezla®, and placebo. 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. The secondary endpoints
include non-inferiority to Otezla® on weeks 16 and 32.
“While the interim analysis data continue to be blinded to
Can-Fite, and the results have only been available to the IDMC,
their recommendation to continue the Phase III psoriasis study and
also to drop one of the dosing groups are highly encouraging. There
is a real market need for an efficacious and safe oral drug for
this devastating disease. We thank the members of both of the IDMCs
for their diligence in reviewing our Phase III interim data and for
making their recommendations.” stated Can-Fite CEO Dr. Pnina
Fishman.
The majority of costs associated with the Phase III Comfort™
study were previously paid, and based on the Company’s current cash
and its anticipated uses, the Company believes it has sufficient
runway to cover the completion of this study.
Piclidenoson has been out-licensed for the indication of
psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong
Kong, Macau, Taiwan, and China. According to iHealthcareAnalyst,
the psoriasis therapeutic market is estimated to reach $11.3
billion by 2025.
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. Piclidenoson is currently under development for the
treatment of autoimmune inflammatory diseases and for the treatment
of COVID-19. It is being evaluated in multinational Phase III
studies as a first line treatment to replace methotrexate in the
treatment of rheumatoid arthritis, and as a treatment for
moderate-to-severe psoriasis.
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 Phase III trials for rheumatoid arthritis and
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 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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