This Company Is Racing Toward Providing Comfort And Safety To Millions Of Psoriasis Sufferers By Mark Gilman, Benzinga
Israel
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October 31, 2022 09:15 AM Eastern Daylight Time
The competition between pharmaceutical company trials to help the 2% to 3% of the population suffering from chronic psoriasis is heating up.
Psoriasis is a chronic inflammatory skin disease caused by genetic disposition or environmental factors and is a burgeoning $16 billion global market, according to Prophecy Market Insights. Pharmaceutical companies are racing to develop new proprietary psoriasis pill options. Bristol-Myers Squibb Co. (NYSE: BMY) just saw its stock soar on news of FDA approval of oral Sotykty, joining Amgen Inc.’s (NASDAQ: AMGN) Otezla which has been the dominant oral pill for psoriasis.
But in addition to the expense of injectables and pills used to bring relief to people living with psoriasis, some of the pill options have so many side effects that many people have decided they aren’t worth ingesting.
Can-Fite’s Piclidenoson Shows Positive Trial Results
Another biotechnology company developing its own proprietary small-molecule drugs has presented new positive data from its Phase III COMFORT study that its Piclidenoson drug has shown a “statistically significant improvement over placebo in psoriasis patients.”
Dr. Kim A. Papp, a world-renowned dermatologist, presented the news from Israel-based Can-Fite BioPharma Ltd. (NYSE American: CANF) at the 31st European Academy of Dermatology and Venerology Congress. The company reports that Piclidenoson is now advancing into a Phase III psoriasis registration trial. Developed by Papp, the protocol will be submitted this year to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance.
Can-Fite is an advanced clinical-stage drug development company with a pipeline of proprietary drugs designed to help multibillion-dollar markets in treating inflammatory, cancer and liver diseases.
Among its Piclidensoson drug study findings, Can-Fite reported:
Its COMFORT Phase III study met its primary endpoint of superiority versus placebo at 16 weeks
Patients treated with Piclidenoson showed an improving progressive response over time
Piclidenoson demonstrated an excellent safety profile, overlapping the placebo-treated group.
Piclidenoson, a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule drug which is orally bioavailable, has an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies, according to Can-Fite.
"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,” Papp said.
Piclidenoson Versus Otezla
The Can-Fite study also found the discontinuation rate by patients taking Amgen’s Otezla was significantly higher than for Piclidenoson, based on what the company referred to as “a significantly better safety profile than Otezla including gastro intestinal-related adverse events that were only 1% for patients on Piclidenoson versus 6% for those on Otezla.” Nervous system disorders were also found to be 0.7% for people taking Piclidenoson compared to 3.3% for patients taking placebo and nearly 10% for those on Otezla.
In the study, Piclidenoson demonstrated a favorable safety profile, showing results were better than the placebo-treated group, as 25.5% of patients treated with placebo had a treatment-emergent adverse event compared to only 14.8% of patients treated with Piclidenoson.
The primary objective of the Can-Fite study was to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily in patients with moderate-to-severe plaque psoriasis compared with a placebo.
Based on the results, analysts have set new price targets for Can-Fite, including Alliance Global Partners ($8.25), CG Capital ($6) and Dawson James Securities and H.C. Wainwright & Co. ($5).
For more information on Can-Fite BioPharma, visit www.canfite.com.
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.
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Forward-Looking StatementsThis 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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