Cipher Pharmaceuticals Inc. recently announced that the company has secured the license to distribute CF101 in Canada. CF101 is a new chemical being advanced by Can-Fite Biopharma to address rheumatoid arthritis and moderate to severe plaque psoriasis.
CF101 has recently completed a Phase 2 and 3 placebo-controlled and double-blinded study thought to evaluate the efficacy of the compound in individuals suffering from moderate to severe plaque psoriasis. 326 patients were enrolled by Can-Fite through 17 clinical centers in the United States, Israel and Europe. Can-Fite will be publishing the outcomes of this trial at the end of March 2015. Interim outcomes from this Phase 2 and 2I trial as well the final results from the previous Phase 2 trial focused on psoriasis revealed to be positive evidencing that CF101 significantly improved the disease symptoms. Furthermore, CF101 finished a Phase 2b evaluation for active rheumatoid arthritis at the end of 2013 and Can-Fite has now completed the design of a Phase 3 program.
Nearly 500,000 people in Canada are under treatment to address psoriasis. The most frequent treatment options for moderate and severe cases are systemic biologic drugs; these are delivered through intravenous (IV) infusion or injection and have well-established shortcomings that include higher risks for infection.
CF101 is a small molecule drug to be taken orally and has a very good safety profile for humans that has been demonstrated in over 1,000 patients. CF101, commercially known as IB-MECA, is a potent anti-inflammatory drug, the effectiveness of which was previously tested in several inflammatory disease models. The drug acts on A3 adenosine receptor (A3AR), a subtype of the adenosine receptor family, whose expression is increased in inflammatory diseases and cancer, while maintaining a low expression in normal cells. CF101 is an agonist of A3AR and induces a specific anti-inflammatory response by modulating the expression of key signalling pathways, including the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB).
“This transaction deepens our Canadian portfolio with a high-potential, novel treatment option for two important indications. As an orally bioavailable drug, we believe CF101 has the potential to offer a much-needed treatment alternative to patients living with psoriasis and rheumatoid arthritis. We see CF101 as being complementary to our Beteflam Patch, giving us two products targeting psoriasis, one of the most common autoimmune diseases in Canada,” concluded the CEO and President of Cipher, Shawn O’Brien.