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The competitionbetween pharmaceutical company trials to help the 2% to 3% of thepopulation suffering from chronic psoriasis is heating up.
Psoriasis is a chronicinflammatory skin disease caused by genetic disposition orenvironmental factors and is a burgeoning $16 billion global market,according to Prophecy market Insights. Pharmaceutical companies areracing to develop new proprietary psoriasis pill options. Bristol-Myers Squibb Co. (NYSE: BMY) just saw its stock soar onnews of FDA approval of oral Sotykty, joining Amgen Inc. ’s(NASDAQ: AMGN) Otezla which has been the dominant oral pill forpsoriasis.
But in addition to theexpense of injectables and pills used to bring relief to people livingwith psoriasis, some of the pill options have so many side effectsthat many people have decided they aren’t worth ingesting.
Can-Fite’s Piclidenoson Shows Positive Trial Results
Another biotechnologycompany developing its own proprietary small-molecule drugs haspresented new positive data from its Phase III COMFORT study that itsPiclidenoson drug has shown a “statistically significant improvementover placebo in psoriasis patients.”
Dr. Kim A. Papp, a world-renowneddermatologist, presented the news from Israel-based Can-FiteBioPharma Ltd. (NYSE American: CANF) at the 31st European Academyof Dermatology and Venerology Congress. The company reports thatPiclidenoson is now advancing into a Phase III psoriasis registrationtrial. Developed by Papp, the protocol will be submitted this year tothe U.S. Food and Drug Administration (FDA) and the European MedicinesAgency (EMA) for market clearance.
Can-Fite is an advanced clinical-stage drugdevelopment company with a pipeline of proprietary drugs designed tohelp multibillion-dollar markets in treating inflammatory, cancer andliver diseases.
Among its Piclidensoson drug study findings, Can-Fite reported:
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Its COMFORT Phase III study met its primaryendpoint of superiority versus placebo at 16 weeks
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Patients treated with Piclidenoson showed animproving progressive response over time
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Piclidenoson demonstrated an excellentsafety profile, overlapping the placebo-treated group.
Piclidenoson, a novel,first-in-class, A3 adenosine receptor agonist (A3AR) small moleculedrug which is orally bioavailable, has an excellent safety profiledemonstrating evidence of efficacy in Phase II clinical studies,according to Can-Fite.
"Thesafety results on Piclidenoson and its progressive effectiveness overthe study period position it as unique among the current treatmentoptions — especially given the chronic nature of psoriasis, whichcan necessitate long-term treatment,” Papp said.
Piclidenoson Versus Otezla
The Can-Fite study also found the discontinuationrate by patients taking Amgen’s Otezla was significantly higher thanfor Piclidenoson, based on what the company referred to as “asignificantly better safety profile than Otezla including gastrointestinal-related adverse events that were only 1% for patients onPiclidenoson versus 6% for those on Otezla.” Nervous systemdisorders were also found to be 0.7% for people taking Piclidenosoncompared to 3.3% for patients taking placebo and nearly 10% for thoseon Otezla.
Inthe 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 adverseevent compared to only 14.8% of patients treated withPiclidenoson.
Theprimary objective of the Can-Fite study was to evaluate the efficacyof oral Piclidenoson 2 mg or 3 mg twice daily in patients withmoderate-to-severe plaque psoriasis compared with a placebo.
Based on the results,analysts have set new price targets for Can-Fite, including AllianceGlobal Partners ($8.25), CG Capital ($6) and Dawson James Securitiesand 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. (NYSEAmerican: CANF) (TASE: CFBI) is an advanced clinical stage drugdevelopment Company with a platform technology that is designed toaddress multi-billion dollar markets in the treatment of cancer,liver, and inflammatory disease. The Company's lead drugcandidate, Piclidenoson recently reported topline results in a PhaseIII trial for psoriasis. Can-Fite's liver drug, Namodenoson, isbeing evaluated in a Phase IIb trial for the treatment ofnon-alcoholic steatohepatitis (NASH), and enrollment is expected tocommence in a Phase III trial for hepatocellular carcinoma (HCC), themost common form of liver cancer. Namodenoson has been granted OrphanDrug Designation in the U.S. and Europe and Fast Track Designation asa second line treatment for HCC by the U.S. Food and DrugAdministration. Namodenoson has also shown proof of concept topotentially treat other cancers including colon, prostate, andmelanoma. CF602, the Company's third drug candidate, has shownefficacy in the treatment of erectile dysfunction. These drugs have anexcellent safety profile with experience in over 1,500 patients inclinical studies to date. For more information please visit:www.can-fite.com.
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Forward-Looking StatementsThispress release may contain forward-looking statements, aboutCan-Fite’s expectations, beliefs or intentions regarding, amongother things, its product development efforts, business, financialcondition, results of operations, strategies or prospects. Allstatements in this communication, other than those relating tohistorical facts, are "forward looking statements".Forward-looking statements can be identified by the use offorward-looking words such as "believe," "expect,""intend," "plan," "may," "should" or"anticipate" or their negatives or other variations of thesewords or other comparable words or by the fact that these statementsdo 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. Becauseforward-looking statements relate to matters that have not yetoccurred, these statements are inherently subject to known and unknownrisks, uncertainties and other factors that may cause Can-Fite’sactual results, performance or achievements to be materially differentfrom any future results, performance or achievements expressed orimplied by the forward-looking statements. Important factors thatcould cause actual results, performance or achievements to differmaterially from those anticipated in these forward-looking statementsinclude, among other things, our history of losses and needs foradditional capital to fund our operations and our inability to obtainadditional capital on acceptable terms, or at all; uncertainties ofcash flows and inability to meet working capital needs; theinitiation, timing, progress and results of our preclinical studies,clinical trials and other product candidate development efforts; ourability to advance our product candidates into clinical trials or tosuccessfully complete our preclinical studies or clinical trials; ourreceipt of regulatory approvals for our product candidates, and thetiming of other regulatory filings and approvals; the clinicaldevelopment, commercialization and market acceptance of our productcandidates; our ability to establish and maintain strategicpartnerships and other corporate collaborations; the implementation ofour business model and strategic plans for our business and productcandidates; the scope of protection we are able to establish andmaintain for intellectual property rights covering our productcandidates and our ability to operate our business without infringingthe intellectual property rights of others; competitive companies,technologies and our industry; risks related to the COVID-19 pandemicand the Russian invasion of Ukraine; risks related to not satisfyingthe continued listing requirements of NYSE American; and statements asto the impact of the political and security situation in Israel on ourbusiness. More information on these risks, uncertainties and otherfactors is included from time to time in the "Risk Factors"section of Can-Fite’s Annual Report on Form 20-F filed with the SECon March 24, 2022 and other public reports filed with the SEC and inits periodic filings with the TASE. Existing and prospective investorsare cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. Can-Fiteundertakes no obligation to publicly update or review anyforward-looking statement, whether as a result of new information,future developments or otherwise, except as may be required by anyapplicable securities laws.
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