TEL AVIV (Reuters) – Can-Fite BioPharma expects to publish positive data at the end of the third quarter regarding the safety and efficacy of its CF101 drug under development for the treatment of psoriasis, the Israeli company‘s acting CEO said on Wednesday.
CF101, a small molecule oral drug, is in advanced clinical development for the treatment of autoimmune inflammatory diseases such as psoriasis, which affects the skin, and rheumatoid arthritis.
Can-Fite acting CEO and founder Pnina Fishman said the company was conducting a Phase II/III clinical study involving 300 patients in the United States, Europe and Israel.
“We are going to have the interim analysis clinical data towards the end of the third quarter,” Fishman told Reuters. “The data is positive … in terms of safety and efficacy.”
Shares in Can-Fite were up 3.8 percent in midday Tel Aviv trade after the clinical trial’s investigators presented their findings to investors.
The most effective treatments for psoriasis on the market are biological drugs focused on blocking the inflammatory factor in the body that causes the disease.
Though the drugs are effective, patients may suffer from adverse events that can cause inflammatory conditions as well as depression and sepsis, Fishman said. The cost of treatment per patient is about $20,000 a year and over time patients can stop responding to the drugs.
“There is a need for another type of drug that won’t be so expensive and will not induce adverse events,” Fishman said.
CF101 is administered as a tablet twice daily while the biological drugs must be administered intravenously.
“We will position it in the market so that the margin of profit will be high for the company but the cost will be much, much lower than for the biological drugs,” Fishman said.
Can-Fite will need to conduct a Phase III study in addition to the Phase II/III study underway to obtain approval from the U.S. Food and Drug Administration. Fishman estimated it would take three to four years to register the drug.
About 2 percent of the world’s population suffers from psoriasis and the market for treatment of the disease is valued at $3.6 billion a year worldwide. This is estimated to grow to $8.5 billion by 2017.
Can-Fite has licensed CF101 for the treatment of autoimmune diseases to Seikagaku Corp in Japan and for rheumatoid arthritis to Kwang Dong in South Korea. Can-Fite so far has received $8.5 million in upfront payments.
“There never will be a cure for psoriasis but we would like to turn it into a disease where the clinical manifestations will be minimal,” Fishman said.
(Reporting by Tova Cohen; Editing by Helen Massy-Beresford)
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