Can Fite BioPharma Ltd (CANF)

[midastouch017]

Can-Fite is Developing a Topical Piclidenoson Psoriasis Treatment that Shows Efficacy in a Preclinical Model: Potential Complementary Product to its Phase III Oral Psoriasis Drug

https://finance.yahoo.com/news/fite-developing-topical-piclidenoson-psoriasis-110000789.html

Topical psoriasis treatments account for 42% of the $11.37 billion psoriasis drug market

Topline results from Phase III oral Piclidenoson study expected Q2 2022

Piclidenoson has been out-licensed for the systemic indication of psoriasis in certain major markets

PETACH TIKVA, Israel, April 05, 2022--(BUSINESS WIRE)--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 it is developing a topical psoriasis treatment with Piclidenoson, its Phase III psoriasis oral drug candidate. The Company’s scientists reported that in a preclinical model, imiquimod-induced skin psoriasis, daily treatment with topical Piclidenoson significantly inhibited the disease as measured by the psoriasis area severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

The Company expects to announce topline results during Q2 2022 from its Phase III randomized, double blind, active and placebo-controlled study conducted in Europe, Israel, and Canada. 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 and secondary endpoints include non-inferiority vs. Otezla®.

"The current preclinical data are important and serve as a basis for further development of a topical Piclidenoson treatment for psoriasis skin lesions, as it may serve as a good complementary product to our oral Piclidenoson drug. We are encouraged by the positive interim analysis reported last year from our Phase III oral Piclidenoson study based on data from 200 patients, and we hope that the data will be reproducible, offering patients safe and long term relief from the symptoms of psoriasis," stated Can-Fite CEO Dr. Pnina Fishman.

According to Persistence Market Research, topical psoriasis treatments account for 41.7% of the psoriasis drug market which was valued at $11.37 billion in 2021 and is projected to grow at a CAGR of 6.5% to $21.48 billion by 2031.

Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.