- Phase III COMFORT™ study met its primary endpoint with
statistically significant improvement and Piclidenoson had an
excellent safety profile
- Can-Fite has licensing deals for the marketing of
Piclidenoson for the treatment of Psoriasis in multiple global
regions
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 positive top-line results from the
COMFORT™ trial, a Phase III, multicenter, randomized, placebo- and
active-controlled, double-blind study to assess the efficacy and
safety of Piclidenoson in more than 400 adults with moderate to
severe plaque psoriasis.
The study data show that patients treated with oral Piclidenoson
2 mg or 3 mg twice daily, had clinically equivalent efficacy
responses. At week 16, patients receiving Piclidenoson 3mg
demonstrated statistically significant improvement when compared
with placebo, as measured by the Psoriasis Area and Severity Index
(PASI) 75 response: Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P<
0.04). Secondary endpoint parameters at week 32 comparing
Piclidenoson to the active control drug, Otezla, revealed
inferiority with respect to PASI 75 (17% vs. 26.2%, respectively)
and PASI 50 (34.1% vs. 49.5%, respectively), but revealed
superiority of Piclidenoson as compared to Otezla in the Psoriasis
Disability Index (PDI) (20.5% vs. 10.3%, respectively, P<0.05).
A linear increase in the response of patients to Piclidenoson was
achieved along the study period, on week 48 reaching PASI 50 in 90%
of patients, PASI 90 in 10% of patients and PDI improvement in 60%
of patients.
Piclidenoson had an excellent safety profile overlapping that of
the placebo treated patients, showing a better safety profile when
compared to Otezla.
“Based on Piclidenoson’s safety and efficacy data revealed in
this trial, we plan to approach the U.S. FDA and the European EMA
with a protocol for a pivotal Phase III study for drug approval and
registration,” stated Can-Fite CEO, Dr. Pnina Fishman.
Dr. Michael T Goldfarb, MD, dermatologist and attending
physician, Beaumont Hospital, Dearborn, Michigan, who has performed
numerous psoriasis clinical trials over the last 38 years,
commented, “Psoriasis causes skin inflammation, which impacts
quality of life for patients. Our aim is to support more patients
in achieving control of their symptoms, and especially using drugs
with a good safety profile in this chronic disease which may
require lifelong treatment. The clinically meaningful improvements
seen in this trial, in both skin symptoms and quality of life,
underline the highly favorable therapeutic index of Piclidenoson in
psoriasis. Taken together, the results of the COMFORT™ trial
strengthen our belief that oral Piclidenoson can address important
unmet needs for patients with psoriasis, where the goal is an
efficacious drug with an excellent safety profile to treat this
chronic and devastating disease.”
Full results from the COMFORT™ Phase III study will be presented
at an upcoming medical conference and published in a peer-reviewed
medical journal.
Can-Fite has five out-licensing deals for marketing and
distribution of Piclidenoson for the treatment of psoriasis in
markets including Canada, Eastern Europe, Central Europe (Austria,
Swiss, Spain), China, and South Korea.
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 has 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
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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
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statements can be identified by the use of forward-looking words
such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or
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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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