Can-Fite: EMA Gives Green Light for Piclidenoson Pivotal Phase III Clinical Trial for Psoriasis Treatment

Rhea-AI Summary

Can-Fite BioPharma (NYSE American: CANF) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding its registration plan for a pivotal Phase III clinical trial targeting moderate to severe psoriasis. The trial will evaluate the safety and efficacy of Piclidenoson, the company's lead drug candidate. This follows the recent successful topline results from the Phase III COMFORT™ study, which demonstrated significant improvement over placebo. Can-Fite is also preparing a comparable data package for the US FDA. The CEO emphasized the drug's oral dosage, safety profile, and potential in a large market for effective psoriasis treatments.

Positive

• Received positive opinion from EMA for a pivotal Phase III trial on Piclidenoson.
• Topline results from Phase III COMFORT™ study showed significant improvement over placebo.
• Excellent safety profile of Piclidenoson established, with data supporting its efficacy.

Negative

• None.

The Pivotal Study is Aimed to Support a Marketing Authorization Application

PETACH TIKVA, Israel,--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency.

The Company intends to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application.

The agency also commented on the registration plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration.

Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson.

“Piclidenoson’s oral dosage and excellent safety record combined with its progressive effectiveness over time make it ideally suited for the treatment of psoriasis, a chronic disease. Should this market registration study produce positive results similar to our COMFORT study, we believe Piclidenoson will be well positioned in a very large market which needs more safe and effective oral drug options,” stated Can-Fite CEO Dr. Pnina Fishman.

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. 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230410005137/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What is the purpose of Can-Fite's Phase III clinical trial?

The Phase III clinical trial aims to demonstrate the clinical safety and efficacy of Piclidenoson for treating moderate to severe psoriasis.

What were the results of the COMFORT™ study?

The COMFORT™ study met its primary endpoint, showing statistically significant improvement over placebo in psoriasis patients.

What is Piclidenoson, and what is its significance in the market?

Piclidenoson is Can-Fite's lead drug candidate, notable for its oral dosage and excellent safety record, offering a potential new option for treating psoriasis.

What are the next steps for Can-Fite after receiving the EMA opinion?

Can-Fite plans to initiate the pivotal Phase III trial and submit a comparable data package to the US FDA for further regulatory review.

How might the results of the Phase III trial impact Can-Fite's stock?

Positive results in the Phase III trial could enhance investor confidence and potentially increase the stock price, given the market demand for effective psoriasis treatments.