Psoriasis Drug Providers Looking Over Shoulders At Upcoming Competitor?

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Pharmaceutical companies involved in psoriasis drug treatment will likely be casting an eye on the outcome of clinical trial data later in the first quarter for a possible new kid on the block.

While several companies offer injectable biologics as their treatment for the chronic condition — AbbVie Inc.’s ABBV Skyrizi and Humira and Novartis AG’s NVS Cosentyx are just a few examples — oral solutions are not so common. Only Amgen Inc.’s AMGN Otezla is currently approved in the United States for oral treatment.

Amgen paid $13.4 billion to buy Otezla when it purchased the drug from then Celgene Corp. in August 2019. Bristol-Myers Squibb Co. BMY purchased Celgene later that year.

That’s why the results from a Phase III trial of Can-Fite Biopharma Ltd.’s CANF Piclidenoson may be of particular interest. The Israel-based company is hoping to sell its oral treatment drug as a direct competitor to Amgen’s Otezla product.

If the Phase III results of the trial confirm such positive data, the company is optimistic that this could transform the value of Can-Fite based on what Amgen paid for Otezla. The placebo results are expected in the first quarter, while the direct comparison with Otezla and the 32-week treatment data will be later in 2022.

The company is awaiting final efficacy data from the trial. Until now, the drug has shown to be safe with use by more than 1,500 patients as well as being superior to a placebo and not inferior to Otezla, according to the company.

Prior data shows that Piclidenoson potentially has better-sustained efficacy compared to Otezla, showing robust anti-inflammatory activity. Data from a published study suggests Piclidenoson's efficacy continues to improve over time whereas Otezla appears to plateau in efficacy beyond week 16.

Biological injectable drugs, meanwhile, are shown to possibly cease to be effective over time with two-thirds of discontinuations attributed to loss of efficacy.

Will Oral Treatment Challenge Injectables?

The $23 billion psoriasis drug market in the U.S. is dominated by the makers of injectable biologics. That said, Amgen’s product has an estimated market share of 35%.

Can-Fite is hoping positive data from the trial will allow it to be a potential competitor offering oral treatment for the chronic condition that accounts for about 3 million new cases annually in the U.S.

The oral treatment option also offers another advantage over the injectable biologics in that such treatment is more affordable.

While the biologics sometimes cost more than $100,000 annually per patient, according to Can-Fite estimates, the company says Otelza costs about $42,000 as a direct comparison.

Piclidenoson, if approved, will likely be another more affordable option for patients, according to Can-Fite.

“As an oral small-molecule drug, Piclidenoson is likely to cost a fraction of the price of injectable biologics sold today,” the company said. “Upon marketing approval, this favorable cost may help Piclidenoson to gain reimbursement and market share.”

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