Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study
29 Enero 2024 - 6:00AM
Business Wire
Piclidenoson is a small molecule safe oral
drug suitable for the chronic treatment of patients who
suffer from moderate to severe plaque psoriasis.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncological and inflammatory diseases,
today announced that the Journal of the European Academy of
Dermatology and Venereology (EADV) published an article titled
“Efficacy and safety of piclidenoson in plaque psoriasis: Results
from a randomized phase 3 clinical trial (COMFORT-1)”. EADV is a
top ranked peer reviewed journal (impact factor 9.2) that publishes
articles on clinical and basic science topics in dermatology.
Article Link.
The article’s first author, Dr. K.A Papp, is an internationally
renowned key opinion leader in the psoriasis field and was the
engine for some registered drugs on the market for this devastating
skin disease.
The EADV article presents the safety and efficacy of
Piclidenoson in the randomized, placebo- and active-controlled,
double-blind Phase III COMFORT-1 trial. As previously reported, the
study met its primary endpoint which was the proportion of patients
achieving ≥75% improvement in Psoriasis Area and Severity Index
(PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75
rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037).
Piclidenoson’s efficacy continued to increase throughout the study
period in a linear manner with an excellent safety and tolerability
profile.
Currently, Piclidenoson is being evaluated in COMFORT-2 a
pivotal Phase III study that has been approved by both the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA).
“We are very much encouraged by the excellent data in the first
Phase III study demonstrating the significant effect of
Piclidenoson in psoriasis,” stated Dr. Fishman, Can-Fite’s Chief
Scientific Officer and Executive Chairman. “We plan to start
treating patients in our pivotal trial very shortly and hope that
Piclidenoson, with its safety and efficacy profile, given orally to
psoriasis patients will become a drug of choice.”
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 and III psoriasis 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 disease pathogenicity. Based
on preclinical efficacy data, Piclidenoson is also being
co-developed for the treatment of Lowe Syndrome, a rare genetic
disease.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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 and is expected
to commence a pivotal Phase III. Can-Fite's cancer and liver drug,
Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of steatotic liver disease (SLD), a Phase III pivotal
trial for hepatocellular carcinoma (HCC), and the Company is
planning a Phase IIa study in pancreatic 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
1,600 patients in clinical studies to date. For more information
please visit: www.canfite.com.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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