Can-Fite: New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by KOL Dr. Papp at the 31st European Academy of Dermatology
September 12 2022 - 7:00AM
Business Wire
- Dr. Papp: “The safety results on Piclidenoson and its
progressive effectiveness over the study period position it as
unique among the current treatment options especially given the
chronic nature of psoriasis which can necessitate long-term
treatment.”
- Piclidenoson has a safety profile similar to placebo and is
better tolerated than Otezla®
- Efficacy of Piclidenoson is similar to Otezla in psoriasis
patients with severe disease
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 Dr. Kim A. Papp, MD, PhD, presented
new data from the Company’s recently completed Phase III COMFORT™
study at the late-breaking news session of the 31st European
Academy of Dermatology and Venerology (EADV) Congress. Can-Fite
previously reported the COMFORT™ study met its primary endpoint
with Piclidenoson showing a statistically significant improvement
over placebo in psoriasis patients. Piclidenoson is advancing into
a pivotal Phase III psoriasis registration trial. The protocol,
which is being designed by Dr. Papp, will be submitted to the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) for market clearance of Piclidenoson in the treatment
of moderate to severe psoriasis.
The following is a summary of key findings presented at EADV on
September 10, 2022 in Milan, Italy during Dr. Papp’s presentation
titled “Treatment of plaque psoriasis with piclidenoson: Efficacy
and safety results from a phase 3 clinical trial (COMFORT)”:
- The COMFORT™ Phase III study met its primary endpoint of
superiority vs. placebo at 16 weeks, p=0.037
- Patients treated with Piclidenoson showed an improving
progressive response over time, and as psoriasis is a chronic
disease that may require long-term treatment, this is an important
finding
- Piclidenoson demonstrated an excellent safety profile,
overlapping that of the placebo-treated group.
- Piclidenoson had a significantly better tolerability profile
than Otezla, as GI-related adverse events were 1% for Piclidenoson
vs. 6% for Otezla, nervous system disorders were 0.7% for
Piclidenoson, 9.9% for Otezla and 3.3% for the placebo. The
discontinuation rate was significantly higher for Otezla vs.
Piclidenoson
- In the secondary endpoint of achieving a PASI 75 response
(representing a 75% reduction in psoriasis severity) at week 32, in
the whole patient population, Piclidenoson was inferior to Otezla;
however, in a sub-group analysis of patients who had PASI>25
(more severe psoriasis) at baseline, Piclidenoson had a comparable
response to Otezla
- In the secondary endpoint of achieving psoriasis disability
index (PDI) response at week 32, Piclidenoson was comparable to
Otezla
Dr. Papp commented, “The safety results on Piclidenoson and its
progressive effectiveness over the study period position it as
unique among the current treatment options especially given the
chronic nature of psoriasis which can necessitate long-term
treatment.”
Dr. Papps’s presentation was based on a study co-performed by
numerous dermatology investigators, in Europe, Israel, and
Canada.
Based in Waterloo, Ontario, Canada, Dr. Papp has over 25 years’
experience as a Principal Investigator. Internationally renowned as
a Key Opinion Leader in clinical research, Dr. Papp has conducted
over 70 international dermatology studies on a wide range of
dermatological disorders. The K. Papp Clinical Research center is
considered one of the top clinical research centers in the world.
Instrumental in improving and refining study designs, Dr. Papp has
completed over 150 research studies on 50 compounds and has worked
on new treatments that are now available and helping tens to
hundreds of thousands of patients with their condition.
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.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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