Race to Effective Psoriasis Treatment: Can-Fite's Piclidenoson May Edge Over High-Flying Amgen's Otezla. Here's Why

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The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Amgen Inc. (NASDAQ: AMGN) recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla for the treatment of adults with mild to moderate plaque psoriasis.

The company also said the FDA had set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 19.

Amgen’s Otezla is enjoying a lot of publicity, flying high as a potent drug for psoriasis. It is actually one of the top-selling psoriasis oral drugs currently on the market.

According to EvaluatePharma, Otezla® sales in 2020 totaled $1.9 billion, with $1.5 billion of the total coming from the U.S. It is forecasted to generate sales of $3.4 billion in 2026, with $2.5 billion coming from the U.S.

The top 10 psoriasis products are expected to generate sales in excess of $32 billion in 2026. As of the end of 2018, Otezla® held approximately 35% new-to-brand market share in psoriasis, significantly above the major competitors in this field.

An Effective Treatment Option from Can-Fite

A recent Phase 3 psoriasis study results released by Israel-based clinical-stage biopharmaceutical company Can-Fite BioPharma Ltd. (NYSE AMERICAN: CANF) CFBI for its Piclidenoson drug has changed the narrative. Piclidenoson may instead be a more compelling option to treat psoriasis.

Psoriasis has been on the radar of several pharmaceutical and drug manufacturers for years now because of the debilitating effects it has on people. Companies are racing to find better treatments and medications for it, which is good for patients.

Like many chronic diseases, psoriasis is on the rise globally, and several factors can be blamed. While scientists don’t know yet what exactly causes psoriasis, we do know that the immune system and genetics play major roles in its development.

Additionally, using biologics over the long-term to treat and cope with psoriasis can have dangerous and unfortunate side effects — all biologics work by suppressing the patient’s immune system and can increase the overall risk of infections.

More than 7.5 million American adults currently have the immune-mediated disease psoriasis — that’s more than 3% of the U.S. adult population.

Unfortunately, psoriasis, a skin disease that causes red, itchy, scaly patches, most commonly on the knees, elbows, trunk and scalp, has no cure. In addition to Otezla, there are a few other drugs such as Humira (adalimumab) from AbbVie Inc. (NYSE: ABBV) and Cosentyx (secukinumab) by Novartis International AG (NYSE: NVS) available on the market that help manage symptoms.

As with other chronic diseases, psoriasis may affect several areas of a person's life in addition to physical health. However, psoriasis can cause social, emotional, and physical distress, especially when it’s visible on the skin in social settings. Read more about psoriasis here.

Piclidenoson More Effective Than Otezla?

Piclidenoson is a novel, first-in-class A3 adenosine receptor agonist (A3AR), small-molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies in autoimmune diseases. The drug is also currently under development to treat COVID-19. Presenting a $20 billion commercial market opportunity in psoriasis, Piclidenoson has some potential advantages over existing treatment options, including oral dosing, outstanding safety and tolerability, and durability of effect that position the drug for success.

A scientific paper reported results from prior Phase 2/3 studies with graphs showing Piclidenoson being more effective than Otezla with longer-term use.

Piclidenoson’s excellent safety profile is key because psoriasis is a chronic condition, and medication needs to be taken long term; in contrast, biologics generally used to treat psoriasis can have serious side effects.

Can-Fite’s Phase 3 study has a positive interim analysis that showed both efficacy and safety based on the Internal Data Monitoring Committee (IDMC) to continue patient enrollment. Topline results from the study are expected Q1 2022.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.