Can-Fite: Positive New Data from it’s Phase III Psoriasis Study will be Presented Today at an Industry Expert Summit in Boston

Rhea-AI Summary

Can-Fite BioPharma (NYSE American: CANF) announced positive results from the Phase III COMFORT study for its drug Piclidenoson, targeting psoriasis. The study showed significant efficacy, surpassing placebo and demonstrating a safety profile comparable to that of placebo and better tolerated than Otezla®. CEO Dr. Pnina Fishman will present the findings at the 6th Annual Dermatology Drug Development Summit in Boston on November 2, 2022. With over 400 adults assessed, the promising outcomes set the stage for an upcoming pivotal Phase III registration trial.

Positive

• Phase III COMFORT study met primary efficacy endpoint for Piclidenoson.
• Piclidenoson demonstrated superior tolerability compared to Otezla®.
• Significant efficacy improvement compared to placebo.

Negative

• None.

• The Summit will host industry drug development experts, all in the dermatology arena, who will present their technologies, exchange views and look at potential collaborations and partnerships.
• Phase III COMFORT study successfully met its primary efficacy endpoint with Piclidenoson showing a safety profile similar to placebo and better tolerated than Otezla^® at the 6^th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases in Boston
• Piclidenoson set for upcoming pivotal Phase III registration trial

PETACH TIKVA, Israel--(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, announced today the Company’s CEO, Dr. Pnina Fishman, will deliver a presentation titled “Piclidenoson for the Treatment of Psoriasis: Clinical Development and Mechanism of Drug Action” at the 6^th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases on November 2, 2022. The Summit takes place in Boston from November 1-3, 2022.

COMFORT™, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis. Piclidenoson demonstrated a statistically significant improvement when compared with placebo as measured by the Psoriasis Area and Severity Index (PASI) 75 response and the Physician Global Assessment (PGA) response index calculated based on the Erythema + Infiltration + Desquamation. The study further showed that in patients with severe disease, Piclidenoson’s efficacy is similar to Otezla^®, currently the top selling oral psoriasis drug. Piclidenoson’s safety profile in the study was similar to placebo and it was better tolerated than Otezla^®.

The Summit will host industry drug development experts, all in the dermatology arena, who will present their technologies, exchange views and look at potential collaboration and partnerships.

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 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.

Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. 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 known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, 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 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; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 24, 2022 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

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Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What are the results of the Phase III COMFORT study conducted by Can-Fite (CANF)?

The Phase III COMFORT study for Can-Fite's Piclidenoson met its primary efficacy endpoint, showing significant improvement compared to placebo.

When will Can-Fite present the results of the COMFORT study?

Can-Fite's CEO, Dr. Pnina Fishman, will present the results at the 6th Annual Dermatology Drug Development Summit on November 2, 2022.

What is the safety profile of Piclidenoson based on the recent study?

Piclidenoson showed a safety profile similar to placebo and was better tolerated than the current leading psoriasis drug, Otezla®.

What is the significance of Piclidenoson in dermatology?

Piclidenoson is positioned for a pivotal Phase III registration trial after demonstrating significant efficacy and safety for treating moderate to severe plaque psoriasis.