Can-Fite anti-Obesity Drug Namodenoson Received Patent Allowance in Australia
Can-Fite BioPharma (NYSE American: CANF) has received patent allowance in Australia for its drug Namodenoson for anti-obesity treatment, valid until 2040. The patent covers methods of treating obese patients using oral Namodenoson, which has shown promising results in reducing fat levels by increasing adiponectin hormone. In a Phase IIa study for MASH patients, the drug demonstrated a 2.3% weight loss after 3 months with significant increases in adiponectin levels. The drug is currently in Phase IIb trials for MASH treatment, where most patients are obese. The global obesity treatment market was valued at USD 12 billion in 2023, with Australia alone expecting approximately 1.85 Million MASH patients.
Can-Fite BioPharma (NYSE American: CANF) ha ricevuto l'approvazione del brevetto in Australia per il suo farmaco Namodenoson per il trattamento dell'obesità, valido fino al 2040. Il brevetto copre i metodi di trattamento dei pazienti obesi utilizzando Namodenoson orale, che ha mostrato risultati promettenti nella riduzione dei livelli di grasso aumentando l'ormone adiponectina. In uno studio di Fase IIa per pazienti MASH, il farmaco ha dimostrato una perdita di peso del 2,3% dopo 3 mesi, con significativi aumenti nei livelli di adiponectina. Attualmente, il farmaco è in fase di sperimentazione IIb per il trattamento della MASH, dove la maggior parte dei pazienti è obesa. Il mercato globale del trattamento dell'obesità è stato valutato 12 miliardi di dollari nel 2023, con l'Australia che si aspetta circa 1,85 milioni di pazienti MASH.
Can-Fite BioPharma (NYSE American: CANF) ha recibido la concesión de patente en Australia para su medicamento Namodenoson para el tratamiento de la obesidad, válido hasta 2040. La patente cubre métodos para tratar a pacientes obesos utilizando Namodenoson oral, que ha mostrado resultados prometedores en la reducción de los niveles de grasa al aumentar la hormona adiponectina. En un estudio de Fase IIa para pacientes MASH, el medicamento demostró una pérdida de peso del 2,3% después de 3 meses, con aumentos significativos en los niveles de adiponectina. Actualmente, el medicamento se encuentra en ensayos de Fase IIb para el tratamiento de MASH, donde la mayoría de los pacientes son obesos. El mercado global de tratamiento de la obesidad fue valorado en 12 mil millones de dólares en 2023, y se espera que Australia tenga aproximadamente 1,85 millones de pacientes MASH.
Can-Fite BioPharma (NYSE American: CANF)는 호주에서 비만 치료를 위한 약물 Namodenoson에 대해 2040년까지 유효한 특허 허가를 받았습니다. 이 특허는 경구용 Namodenoson을 사용하여 비만 환자를 치료하는 방법을 포함하고 있으며, adiponectin 호르몬을 증가시켜 지방 수치를 줄이는 데 유망한 결과를 보여주었습니다. MASH 환자를 위한 2상 IIa 연구에서 이 약물은 3개월 후 2.3%의 체중 감소를 보여주고 adiponectin 수준의 상당한 증가를 기록했습니다. 현재 이 약물은 비만 환자가 대부분인 MASH 치료를 위한 2상 IIb 임상 시험 중에 있습니다. 2023년 글로벌 비만 치료 시장은 120억 달러로 평가되었으며, 호주에서만 약 185만 명의 MASH 환자가 있을 것으로 예상됩니다.
Can-Fite BioPharma (NYSE American: CANF) a reçu l'autorisation de brevet en Australie pour son médicament Namodenoson destiné au traitement de l'obésité, valable jusqu'en 2040. Le brevet couvre les méthodes de traitement des patients obèses en utilisant Namodenoson par voie orale, qui a montré des résultats prometteurs pour réduire les niveaux de graisse en augmentant l'hormone adiponectine. Dans une étude de Phase IIa pour les patients MASH, le médicament a démontré une perte de poids de 2,3% après 3 mois, avec des augmentations significatives des niveaux d'adiponectine. Le médicament est actuellement en essais de phase IIb pour le traitement de la MASH, où la majorité des patients sont obèses. Le marché mondial du traitement de l'obésité a été évalué à 12 milliards de dollars en 2023, l'Australie s'attendant à environ 1,85 million de patients MASH.
Can-Fite BioPharma (NYSE American: CANF) hat in Australien die Patenterlaubnis für sein Medikament Namodenoson zur Behandlung von Übergewicht erhalten, gültig bis 2040. Das Patent umfasst Methoden zur Behandlung von adipösen Patienten mit oralem Namodenoson, das vielversprechende Ergebnisse bei der Reduzierung des Fettgehalts durch Erhöhung des Adiponektin-Hormons gezeigt hat. In einer Phase-IIa-Studie bei MASH-Patienten zeigte das Medikament einen Gewichtsverlust von 2,3% nach 3 Monaten mit signifikanten Erhöhungen der Adiponektin-Spiegel. Das Medikament befindet sich derzeit in Phase-IIb-Studien zur Behandlung von MASH, wo die meisten Patienten übergewichtig sind. Der globale Markt für die Behandlung von Übergewicht wurde 2023 mit 12 Milliarden US-Dollar boniert, wobei Australien allein etwa 1,85 Millionen MASH-Patienten erwartet.
- Patent protection secured in Australia until 2040 for anti-obesity treatment
- Demonstrated 2.3% weight loss in Phase IIa MASH study after 3 months
- Proven favorable safety profile in all clinical studies
- Targeting large market opportunity valued at USD 12 billion globally
- None.
Insights
The patent allowance in Australia for Namodenoson's anti-obesity application represents a moderate development for Can-Fite BioPharma. While patent protection until 2040 is valuable, several factors temper the immediate impact: Phase IIb trials are still ongoing and the 2.3% weight loss observed in Phase IIa, while promising, requires validation in larger studies.
The Australian market opportunity of 1.85 million MASH patients is notable, but represents only a fraction of the
For investors, this patent strengthens Can-Fite's IP portfolio but doesn't fundamentally alter near-term prospects. The company's
Namodenoson is an oral drug with a proven favorable safety profile
RAMAT GAN, Israel, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced an update related to the intellectual property (IP) status of its lead drug candidate Namodenoson, currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced liver cancer and pancreatic cancer. In all clinical studies that have been conducted, Namodenoson had a very favorable safety profile when administered orally.
The patent application No.2020205042, entitled “An A3 adenosine receptor ligand for use for achieving a fat loss effect”, has been accepted by the Australian Patent Office and expires in 2040.
The patent application covers methods of treating obese patients by administering Namodenoson in an oral formulation. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, including Europe and the US for the different clinical applications of the drug.
The anti-obesity patent application is based on data demonstrating that treatment of fat cells with Namodenoson, reduced fat levels via the increase of the hormone adiponectin, a regulator of fat production in the body. Namodenoson also reduced body weight in an experimental animal model of obesity, induced by a high fat diet. In a Phase IIa study in MASH patients treated with Namodenoson, a 2.3 % weight loss has been observed after 3 months with a significant increase in serum adiponectin levels.
”We are delighted that the product protection of Namodenoson in the area of obesity has been accepted in Australia and will be valid till 2040. Namodenoson is currently being developed for the treatment of MASH in a Phase IIb study, where most patients are obese. We look forward to see the anti-obesity effect in this clinical study”, said Pnina Fishman, Ph.D., Can-Fite CSO and Chairperson.
The global obesity treatment market is lucrative due to the awareness of a link between chronic diseases and obesity and according to Market Research Future was valued at USD 12 billion in 2023. In Australia only, there are expected to be approximately 1.85 Million MASH patients https://pmc.ncbi.nlm.nih.gov/articles/PMC7540570/pdf/JGH-35-1628.pdf
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
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 MASH a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic 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 1,600 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 any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; 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 28, 2024 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.
Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114
FAQ
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