【Can-Fite BioPharma-Product CF101】New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by Kol Dr. Papp at the 31st European Academy of Dermatology

Partner News

12 September, 2022- Can-Fite BioPharma issued a press release, which is summarized as follows: 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.

The original website link: https://ir.canfite.com/news-events/press-releases/detail/999/can-fite-new-phase-iii-psoriasis-data-showing-superior