The competition between pharmaceutical company trials to help the 2% to 3% of the population suffering from chronic psoriasis is heating up.
Psoriasis is a chronic inflammatory skin disease caused by genetic disposition or environmental factors and is a burgeoning $16 billion global market, according to Prophecy Market Insights. Pharmaceutical companies are racing to develop new proprietary psoriasis pill options. Bristol-Myers Squibb Co. BMY just saw its stock soar on news of FDA approval of oral Sotykty, joining Amgen Inc.’s AMGN Otezla which has been the dominant oral pill for psoriasis.
But in addition to the expense of injectables and pills used to bring relief to people living with psoriasis, some of the pill options have so many side effects that many people have decided they aren’t worth ingesting.
Can-Fite’s Piclidenoson Shows Positive Trial Results
Another biotechnology company developing its own proprietary small-molecule drugs has presented new positive data from its Phase III COMFORT study that its Piclidenoson drug has shown a “statistically significant improvement over placebo in psoriasis patients.”
Dr. Kim A. Papp, a world-renowned dermatologist, presented the news from Israel-based Can-Fite BioPharma Ltd. CANF at the 31st European Academy of Dermatology and Venerology Congress. The company reports that Piclidenoson is now advancing into a Phase III psoriasis registration trial. Developed by Papp, the protocol will be submitted this year to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance.
Can-Fite is an advanced clinical-stage drug development company with a pipeline of proprietary drugs designed to help multibillion-dollar markets in treating inflammatory, cancer and liver diseases.
Among its Piclidensoson drug study findings, Can-Fite reported:
- Its COMFORT Phase III study met its primary endpoint of superiority versus placebo at 16 weeks
- Patients treated with Piclidenoson showed an improving progressive response over time
- Piclidenoson demonstrated an excellent safety profile, overlapping the placebo-treated group.
Piclidenoson, a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule drug which is orally bioavailable, has an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies, according to Can-Fite.
"The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options — especially given the chronic nature of psoriasis, which can necessitate long-term treatment,” Papp said.
Piclidenoson Versus Otezla
The Can-Fite study also found the discontinuation rate by patients taking Amgen’s Otezla was significantly higher than for Piclidenoson, based on what the company referred to as “a significantly better safety profile than Otezla including gastro intestinal-related adverse events that were only 1% for patients on Piclidenoson versus 6% for those on Otezla.” Nervous system disorders were also found to be 0.7% for people taking Piclidenoson compared to 3.3% for patients taking placebo and nearly 10% for those on Otezla.
In the study, Piclidenoson demonstrated a favorable safety profile, showing results were better than the placebo-treated group, as 25.5% of patients treated with placebo had a treatment-emergent adverse event compared to only 14.8% of patients treated with Piclidenoson.
The primary objective of the Can-Fite study was to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily in patients with moderate-to-severe plaque psoriasis compared with a placebo.
Based on the results, analysts have set new price targets for Can-Fite, including Alliance Global Partners ($8.25), CG Capital ($6) and Dawson James Securities and H.C. Wainwright & Co. ($5).
For more information on Can-Fite BioPharma, visit www.canfite.com.
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