Industry Analysts Seemingly Sing Praises For This Stock After Phase III Trial Results

Psoriasis is a common chronic disease mediated by the immune system. It’s characterized by red, scaly patches that form on the skin. Psoriasis affects more than 3% of the U.S. adult population — over 7.5 million people.

Like most chronic diseases that affect physical health, psoriasis can impede a sufferer’s mental and emotional health and relationships, and treatment can be stressful.

Shame And Anxiety

A study on the physical and social functioning impacts among people with psoriasis as of 2014 revealed that about 58% of individuals with the disease claimed to experience some feelings of shame and anxiety.

The physical and psychological impacts have seemingly prompted a race to find effective treatment regimens to enable patients to have their lives back in full.

This has reportedly opened up a $4.4 billion psoriasis drug market opportunity for big players like Pfizer Inc. PFE, Johnson & Johnson JNJ and Merck & Co. Inc. MRK, which are actively ramping up research, trials and drug development to aid treatment.

Trial Of Hope?

But recent top-line results from the Phase III COMFORT™ trial by Can-Fite BioPharma Ltd. CANF CFBI could trigger some excitement and hope for patients and the industry as a whole.

The Israeli biopharmaceutical company is not new to such trials and drug developments. Can-Fite has, over the years, advanced a pipeline of proprietary small-molecule drugs that address inflammatory, cancer and liver diseases.

According to a company release, the positive top-line Phase III results were from a multicenter, randomized, placebo- and active-controlled, double-blind study to assess the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.

The study data, Can-Fite said, showed that patients treated with oral 2 milligrams or 3 mg of Piclidenoson twice daily had clinically equivalent efficacy responses.

At week 16, patients receiving 3 mg of Piclidenoson demonstrated statistically significant improvement when compared with placebos, as measured by the Psoriasis Area and Severity Index (PASI) 75 response: Piclidenoson 3 mg: 9.7% versus placebo: 2.6% (P< 0.04).

Secondary endpoint parameters at week 32 comparing Piclidenoson to the active control drug Otezla revealed inferiority with respect to PASI 75 (17% versus 26.2%, respectively) and PASI 50 (34.1% versus 49.5%, respectively), but revealed superiority of Piclidenoson as compared to Otezla in the Psoriasis Disability Index (P.D.I.) (20.5% versus 10.3%, respectively, P<0.05).

A linear increase in patients’ response to Piclidenoson was achieved during the study period, on week 48, reaching PASI 50 in 90% of patients, PASI 90 in 10% of patients and P.D.I. improvement in 60% of patients.

Piclidenoson had an excellent safety profile overlapping that of the placebo-treated patients, showing a better safety profile when compared to Otezla, Can-Fite claimed.

Industry Analyst Reports

Reacting to the Phase III COMFORT™ trial, H.C. Wainwright & Co. said, “We believe Can-Fite’s five out-licensing agreements for marketing and distribution of Piclidenoson for marketing and distribution in Canada, Eastern Europe, Central Europe (Austria, Switzerland, Spain), China and South Korea suggest the potential for signing a lucrative out-licensing deal for the U.S., U.K. and rest of the EU markets.”

A.G.P./Alliance Global Partners noted: “Confirmatory Phase III next in the first quarter of 2023. With the COMFORT trial complete, the company plans to meet with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the protocol for a second, confirmatory Phase III clinical trial for Piclidenoson.”

“Otezla sold over $2 billion in 2021, showing the significant market opportunity should Piclidenoson ultimately be approved. Can-Fite is also looking to develop a topical version of Piclidenoson that has shown promising potential in preclinical models to inhibit psoriasis.”

GC Capital said: “Believe pace of commercialization will quicken. Can-Fite management has historically partnered with leading global Rx players to speed potential commercialization and marketing of their compounds. Historically, these agreements include upfront, non dilutive payments and double-digit royalty rates.”

“Currently, Can-Fite has five out-licensing deals for marketing and distribution of Piclidenoson for psoriasis in Canada, Eastern Europe, Central Europe, China and South Korea. There remain opportunities for further agreements in key markets such as the United States, South America, United Kingdom, France, Japan and Australia, among others. As such, we believe the COMFORT data release will provide a key catalyst for new licensing transactions and the potential for further material non-dilutive financing.”

Can-Fite says it plans to present full results from the COMFORT™ Phase III study at an upcoming medical conference and publish them in a peer-reviewed medical journal.

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