Can-Fite BioPharma Ltd. announced it received a Notice of Allowance from Brazil's National Institute of Industrial Property for its patent application covering CF602, a novel erectile dysfunction treatment targeting patients with diabetes and those who do not respond to current standard-of-care medications. The patent, titled "An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction," expands intellectual property protection for the drug candidate beyond existing patents in the U.S. and Europe.
Addressing Significant Treatment Gaps
The erectile dysfunction market, valued at $3.2 billion, faces substantial treatment limitations with current therapies. Standard-of-care medications including Viagra, Cialis, Levitra, and Stendra are phosphodiesterase type 5 (PDE5) inhibitors that demonstrate efficacy in approximately 65%-70% of patients. However, an estimated 30% to 35% of erectile dysfunction patients are non-responders to these treatments.
The treatment gap becomes more pronounced for diabetic patients, as PDE5 inhibitors can be contraindicated for people living with diabetes, representing 16 million men in the U.S. alone. "Given the large percentage of non-responders and those living with diabetes who are contraindicated for taking the most widely prescribed ED medications, we believe CF602 has the potential to meet a large and unmet need," stated Motti Farbstein, Can-Fite CEO.
Novel Mechanism of Action
CF602 represents a departure from current erectile dysfunction treatments through its unique mechanism as an A3 adenosine receptor (A3AR) allosteric modulator. Unlike PDE5 inhibitors, CF602 enhances receptor activity in the presence of the native ligand while maintaining high selectivity at the A3AR. The molecule is designed to avoid receptor desensitization, thereby magnifying agonist activity at low doses.
This mechanism enables CF602 to be administered both topically and orally, providing flexibility in treatment delivery that current oral-only PDE5 inhibitors cannot offer.
Preclinical Efficacy Data
A study published in the journal Andrologia by Can-Fite scientists demonstrated CF602's therapeutic potential in diabetic rat models. The research showed that a single dose of CF602 achieved full erectile recovery with restored muscle collagen ratio and endothelial cell function.
When applied topically or orally in the diabetic rat model, CF602 resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM). Additional benefits included improvements in smooth muscle/collagen ratio, vascular endothelial growth factor, and endothelial nitric oxide synthase.
Expanding Patent Portfolio
The Brazilian patent allowance represents a strategic expansion of Can-Fite's intellectual property protection for CF602 in erectile dysfunction applications. "This latest patent in Brazil geographically expands intellectual property protection for CF602 in ED beyond the major markets of the U.S. and Europe where patents have already been granted," Farbstein noted.
Can-Fite BioPharma is an advanced clinical-stage biotechnology company with a platform technology designed to address multi-billion-dollar markets in cancer, liver, and inflammatory diseases. The company's pipeline includes Piclidenoson, which reported topline results in a Phase III psoriasis trial, and Namodenoson, currently in Phase III trials for hepatocellular carcinoma and Phase IIb trials for MASH treatment.
