Piclidenoson Takes On Otezla, a $13 Billion Psoriasis Drug

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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.

If you watch TV, chances are you’ve heard about Otezla, a medication used to treat certain types of psoriasis and psoriatic arthritis by Amgen Inc. AMGN.

Can-Fite Biopharma’s CANF drug Piclidenoson may prove to be just as  — or even more — effective than Amgen’s Otezla, which the pharma giant acquired for $13.4 billion from Celgene Corp. CELG in 2019.

Results from a Phase III study comparing Piclidenoson to placebo and Otezla are due in the 1st quarter. Positive results for Piclidenoson may mean a boost for its valuation.

Patients in the Phase III COMFORT study will complete a 16-week cycle of treatment in early January while investors and big pharma alike may be closely watching for the results, which will be released shortly after the trial is complete.

With Can-Fite designing the study to go head-to-head with Otezla, Amgen likely will be particularly interested in the results. Otezla generated $2.2 billion in sales for Amgen in 2020 and is projected to generate sales of $3.4 billion in 2026, according to Evaluate Pharma, a data engineering company that covers the pharmaceutical industry.

Designed to Succeed?

The Can-Fite Phase III study will evaluate the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response greater than or equal to 75%, PASI 75 at week 16. During weeks 16 to 32, the results will determine how Piclidenoson stacks up against Otezla.

Can-Fite reported that Piclidenoson proved to be more effective than Otezla at week 32, suggesting a better long-term outcome for patients with psoriasis, a chronic disease. At 32 weeks, 64% of Piclidenoson patients achieved a response score of PASI 50 versus only 49% of Otezla patients; 35% of Piclidenoson patients achieved PASI 75 versus 26% of Otezla patients; and 25% of Piclidenoson patients achieved PASI 90 versus 8% of Otezla patients.

Studies show that Piclidenoson, which has been tested in more than 2,000 patients with no significant safety issues, is safe and well-tolerated at doses up to 4 milligrams.

Taking on Otezla

The PASI scores comparing Piclidenoson and Otezla reveal that Can-Fite’s quest to take on Amgen makes sense. Both drugs are orally available, which could be a big dosing advantage over injection-based biologics like Humira, Enbrel, and Cosentyx. Oral dosing has allowed Otezla to capture a significant portion of the psoriasis market — 35% of the new-to-brand market share in psoriasis.

If data from Can-Fite’s Phase III COMFORT study confirm Piclidenoson is as effective as Otezla during weeks 16 to 32, the company might be in an excellent position to take on Amgen’s $13 billion blockbuster drug. Analyses from the Otezla clinical trials show a high incidence of gastrointestinal (GI) adverse reactions, including diarrhea and nausea. A higher incidence of adverse GI reactions has not been found in Piclidenoson.

More than 7.5 million American adults have the immune-mediated disease psoriasis — more than 3% of the U.S. adult population. The top 10 psoriasis products are expected to generate more than $32 billion in sales in 2026.

Pfizer Inc. PFE tried and failed to gain approval for the treatment of moderate to severe plaque psoriasis with the Janus kinase (JAK) inhibitor Xeljanz in 2015. The drug is approved for rheumatoid arthritis and psoriatic arthritis, but the Food and Drug Administration recently required warnings for JAK inhibitors, including Xeljanz and Rinvoq, noting the increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death.

The odds point to success could put the company in an excellent position to strike a deal for Piclidenoson in 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.